{
"NDC": [
{
"NDCCode": "59779-264-66",
"PackageDescription": "48 g in 1 JAR (59779-264-66)",
"NDC11Code": "59779-0264-66",
"ProductNDC": "59779-264",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Revitalift Complete With Spf-15",
"NonProprietaryName": "Ensulizole And Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100719",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ENSULIZOLE; OCTINOXATE",
"StrengthNumber": "17; 75",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "12634-264-66",
"PackageDescription": "6 TABLET in 1 BLISTER PACK (12634-264-66)",
"NDC11Code": "12634-0264-66",
"ProductNDC": "12634-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040099",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each tablet contains: Hydrocodone Bitartrate...... 5 mg Acetaminophen.................. 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD&C Yellow #6. Meets USP Dissolution Test 1."
},
{
"NDCCode": "59779-010-66",
"PackageDescription": "177 mL in 1 BOTTLE, PLASTIC (59779-010-66)",
"NDC11Code": "59779-0010-66",
"ProductNDC": "59779-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Anti-gas",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Demithicone",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090429",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "CVS",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE",
"StrengthNumber": "200; 200; 20",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-09"
},
{
"NDCCode": "59779-458-66",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (59779-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59779-0458-66",
"ProductNDC": "59779-458",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"ProprietaryNameSuffix": "Indoor And Outdoor Allergies",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078336",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130614",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "59779-735-66",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-735-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "59779-0735-66",
"ProductNDC": "59779-735",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Dm Extended Release",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091070",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "60; 1200",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "59779-948-66",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-948-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "59779-0948-66",
"ProductNDC": "59779-948",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Extended Release",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091009",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0074-2108-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2108-03",
"ProductNDC": "0074-2108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2282-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2282-03",
"ProductNDC": "0074-2282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-2440-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-2440-03",
"ProductNDC": "0074-2440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3346-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3346-03",
"ProductNDC": "0074-3346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3346-55",
"PackageDescription": "1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3346-55",
"ProductNDC": "0074-3346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3473-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3473-03",
"ProductNDC": "0074-3473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3473-55",
"PackageDescription": "1 KIT in 1 CELLO PACK (0074-3473-55) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3473-55",
"ProductNDC": "0074-3473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3575-01",
"PackageDescription": "1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) ",
"NDC11Code": "00074-3575-01",
"ProductNDC": "0074-3575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3642-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3642-03",
"ProductNDC": "0074-3642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19890126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019732",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19890127",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3642-55",
"PackageDescription": "1 KIT in 1 CELLO PACK (0074-3642-55) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3642-55",
"ProductNDC": "0074-3642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19890126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019732",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3683-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3683-03) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3683-03",
"ProductNDC": "0074-3683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951223",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3683-55",
"PackageDescription": "1 KIT in 1 CELLO PACK (0074-3683-55) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-3683-55",
"ProductNDC": "0074-3683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19951222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020517",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260315",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-3779-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-3779-03) * 1 SWAB in 1 PACKET * 1.5 mL in 1 SYRINGE",
"NDC11Code": "00074-3779-03",
"ProductNDC": "0074-3779",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0074-9694-03",
"PackageDescription": "1 KIT in 1 CARTON (0074-9694-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET",
"NDC11Code": "00074-9694-03",
"ProductNDC": "0074-9694",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "19930416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930416",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "25021-801-66",
"PackageDescription": "1 VIAL in 1 CARTON (25021-801-66) > 5 mL in 1 VIAL",
"NDC11Code": "25021-0801-66",
"ProductNDC": "25021-801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091493",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": ".8",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141229",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .",
"Description": "Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. : 1 Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg of zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP. ."
},
{
"NDCCode": "76333-264-01",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (76333-264-01) > 10 CAPSULE in 1 BLISTER PACK (76333-264-26) ",
"NDC11Code": "76333-0264-01",
"ProductNDC": "76333-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210729",
"LabelerName": "Orient Pharma Co.,Ltd Yunlin Plant",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190725",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) : 1 C. difficile -associated diarrhea , 2 Enterocolitis caused by Staphylococcus aureus (including methicillin- resistant strains) .",
"Description": "Vancomycin Hydrochloride Capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The capsules contain 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride).These capsules also contain polyethylene glycol 6000, FD&C Yellow No. 5, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate and gelatin. The capsules contain 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, yellow iron oxide, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate, gelatin. Both 125 mg and 250 mg capsules are imprinted with ink which may contain titanium dioxide, carnauba wax, white shellac, glyceryl monooleate. Vancomycin hydrochloride has the structural formula:."
},
{
"NDCCode": "76333-264-17",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (76333-264-17) ",
"NDC11Code": "76333-0264-17",
"ProductNDC": "76333-264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210729",
"LabelerName": "Orient Pharma Co.,Ltd Yunlin Plant",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190725",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) : 1 C. difficile -associated diarrhea , 2 Enterocolitis caused by Staphylococcus aureus (including methicillin- resistant strains) .",
"Description": "Vancomycin Hydrochloride Capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The capsules contain 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride).These capsules also contain polyethylene glycol 6000, FD&C Yellow No. 5, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate and gelatin. The capsules contain 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, yellow iron oxide, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate, gelatin. Both 125 mg and 250 mg capsules are imprinted with ink which may contain titanium dioxide, carnauba wax, white shellac, glyceryl monooleate. Vancomycin hydrochloride has the structural formula:."
},
{
"NDCCode": "0006-0568-40",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (0006-0568-40) ",
"NDC11Code": "00006-0568-40",
"ProductNDC": "0006-0568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolinza",
"NonProprietaryName": "Vorinostat",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20061006",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021991",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "VORINOSTAT",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20061006",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLINZA® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.",
"Description": "ZOLINZA contains vorinostat, which is described chemically as N-hydroxy-N'-phenyloctanediamide. The empirical formula is C14H20N2O3. The molecular weight is 264.32 and the structural formula is. Vorinostat is a white to light orange powder. It is very slightly soluble in water, slightly soluble in ethanol, isopropanol and acetone, freely soluble in dimethyl sulfoxide and insoluble in methylene chloride. It has no chiral centers and is non-hygroscopic. The differential scanning calorimetry ranged from 161.7 (endotherm) to 163.9°C. The pH of saturated water solutions of vorinostat drug substance was 6.6. The pKa of vorinostat was determined to be 9.2. Each 100 mg ZOLINZA capsule for oral administration contains 100 mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The capsule shell excipients are titanium dioxide, gelatin and sodium lauryl sulfate."
},
{
"NDCCode": "0009-0046-01",
"PackageDescription": "264 VIAL in 1 CONTAINER (0009-0046-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0009-0046-40) ",
"NDC11Code": "00009-0046-01",
"ProductNDC": "0009-0046",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Parecoxib Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "PARECOXIB SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "03-JUL-14"
},
{
"NDCCode": "0143-9150-10",
"PackageDescription": "10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) ",
"NDC11Code": "00143-9150-10",
"ProductNDC": "0143-9150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combogesic Iv",
"NonProprietaryName": "Acetaminophen And Ibuprofen Injection",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215320",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ACETAMINOPHEN; IBUPROFEN",
"StrengthNumber": "1000; 300",
"StrengthUnit": "mg/100mL; mg/100mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240205",
"SamplePackage": "N",
"IndicationAndUsage": "COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for: the relief of mild to moderate pain the management of moderate to severe pain as an adjunct to opioid analgesicsLimitations of Use COMBOGESIC IV is indicated for short-term use of five days or less.",
"Description": "COMBOGESIC IV (acetaminophen and ibuprofen) injection contains acetaminophen and ibuprofen, a nonsteroidal anti-inflammatory drug. Acetaminophen chemical name is N-acetyl-p-aminophenol. Acetaminophen is a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is soluble in boiling water and 1N sodium hydroxide and is freely soluble in alcohol. Acetaminophen has a molecular weight of 151.16. The molecular formula is C8H9NO2 and the structural formula is. Ibuprofen sodium dihydrate chemical name is 2-(4-isobutyl phenyl) propionic acid sodium salt dihydrate. Ibuprofen sodium dihydrate is a white powder. It has a molecular weight of 264.29. It is freely soluble in water. The molecular formula is C13H21NaO4 and the structural formula of ibuprofen sodium dihydrate is represented below. COMBOGESIC IV injection is a sterile, clear, colorless, non-pyrogenic, isotonic solution, intended for intravenous infusion with a pH stability range of 6.3-7.3. Each single-dose 100 mL vial contains 1,000 mg of acetaminophen and 300 mg of ibuprofen base (equivalent to 385 mg of ibuprofen sodium dihydrate), 25 mg of Cysteine hydrochloride monohydrate, 13 mg of Disodium phosphate dihydrate, 3,285 mg of Mannitol, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injection."
},
{
"NDCCode": "0143-9642-01",
"PackageDescription": "5 mL in 1 VIAL (0143-9642-01) ",
"NDC11Code": "00143-9642-01",
"ProductNDC": "0143-9642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202182",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130603",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic acid injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) .",
"Description": "Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2 H2O and its molar mass is 290.1 g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic acid injection is available in 5 mL vials as a sterile liquid concentrate solution for intravenous infusion. Each 5 mL concentrate vial contains 4.264 mg zoledronic acid monohydrate, equivalent to 4 mg zoledronic acid on an anhydrous basis, 220 mg of Mannitol, USP, Water for Injection, USP, and 24 mg of Sodium Citrate, USP. Inactive Ingredients: Mannitol, USP, as bulking agent, Water for Injection, and Sodium Citrate, USP, as buffering agent."
},
{
"NDCCode": "0409-4215-01",
"PackageDescription": "1 VIAL, PLASTIC in 1 CARTON (0409-4215-01) / 5 mL in 1 VIAL, PLASTIC",
"NDC11Code": "00409-4215-01",
"ProductNDC": "0409-4215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoledronic Acid",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090621",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171019",
"SamplePackage": "N",
"IndicationAndUsage": "Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 1 Hypercalcemia of malignancy. (1.1), 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2).",
"Description": "Zoledronic acid is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2∙H2O and its molar mass is 290.1 g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic acid is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. : 1 Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and sodium citrate, to adjust pH."
},
{
"NDCCode": "0615-8434-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-8434-39) ",
"NDC11Code": "00615-8434-39",
"ProductNDC": "0615-8434",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202330",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220714",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge\", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "0904-6899-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-6899-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-6899-61",
"ProductNDC": "0904-6899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140503",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>59779-264-66</NDCCode>
<PackageDescription>48 g in 1 JAR (59779-264-66)</PackageDescription>
<NDC11Code>59779-0264-66</NDC11Code>
<ProductNDC>59779-264</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Revitalift Complete With Spf-15</ProprietaryName>
<NonProprietaryName>Ensulizole And Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100719</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE</SubstanceName>
<StrengthNumber>17; 75</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12634-264-66</NDCCode>
<PackageDescription>6 TABLET in 1 BLISTER PACK (12634-264-66)</PackageDescription>
<NDC11Code>12634-0264-66</NDC11Code>
<ProductNDC>12634-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040099</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Each tablet contains: Hydrocodone Bitartrate...... 5 mg Acetaminophen.................. 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD&C Yellow #6. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>59779-010-66</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, PLASTIC (59779-010-66)</PackageDescription>
<NDC11Code>59779-0010-66</NDC11Code>
<ProductNDC>59779-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antacid Anti-gas</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Demithicone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090429</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE</SubstanceName>
<StrengthNumber>200; 200; 20</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>59779-458-66</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (59779-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0458-66</NDC11Code>
<ProductNDC>59779-458</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Indoor And Outdoor Allergies</ProprietaryNameSuffix>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078336</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59779-735-66</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-735-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0735-66</NDC11Code>
<ProductNDC>59779-735</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Dm Extended Release</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091070</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>60; 1200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59779-948-66</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-948-66) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0948-66</NDC11Code>
<ProductNDC>59779-948</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Extended Release</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091009</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0074-2108-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2108-03</NDC11Code>
<ProductNDC>0074-2108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
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<NDC>
<NDCCode>0074-2282-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2282-03</NDC11Code>
<ProductNDC>0074-2282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
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<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
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<NDCCode>0074-2440-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
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<ProductNDC>0074-2440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3346-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3346-03</NDC11Code>
<ProductNDC>0074-3346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3346-55</NDCCode>
<PackageDescription>1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3346-55</NDC11Code>
<ProductNDC>0074-3346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3473-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3473-03</NDC11Code>
<ProductNDC>0074-3473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3473-55</NDCCode>
<PackageDescription>1 KIT in 1 CELLO PACK (0074-3473-55) * 1.5 mL in 1 SYRINGE (0074-9945-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3473-55</NDC11Code>
<ProductNDC>0074-3473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3575-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) </PackageDescription>
<NDC11Code>00074-3575-01</NDC11Code>
<ProductNDC>0074-3575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3642-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3642-03</NDC11Code>
<ProductNDC>0074-3642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19890126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019732</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3642-55</NDCCode>
<PackageDescription>1 KIT in 1 CELLO PACK (0074-3642-55) * 1 mL in 1 SYRINGE (0074-9907-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3642-55</NDC11Code>
<ProductNDC>0074-3642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19890126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019732</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3683-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3683-03) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3683-03</NDC11Code>
<ProductNDC>0074-3683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3683-55</NDCCode>
<PackageDescription>1 KIT in 1 CELLO PACK (0074-3683-55) * 1.5 mL in 1 SYRINGE (0074-9930-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-3683-55</NDC11Code>
<ProductNDC>0074-3683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020517</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated for the treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:. LUPRON DEPOT 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 22.5 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS. The front chamber of LUPRON DEPOT 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 30 mg for 4-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 16 WEEKS. The front chamber of LUPRON DEPOT 30 mg for 4-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given ONCE EVERY 24 WEEKS. The front chamber of LUPRON DEPOT 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-3779-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3779-03) * 1 SWAB in 1 PACKET * 1.5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00074-3779-03</NDC11Code>
<ProductNDC>0074-3779</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0074-9694-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-9694-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-9694-03</NDC11Code>
<ProductNDC>0074-9694</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19930416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>25021-801-66</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-801-66) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0801-66</NDC11Code>
<ProductNDC>25021-801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091493</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) , 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2) .</IndicationAndUsage>
<Description>Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2H2O and its molar mass is 290.1g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic Acid Injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. : 1 Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg of zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP. .</Description>
</NDC>
<NDC>
<NDCCode>76333-264-01</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (76333-264-01) > 10 CAPSULE in 1 BLISTER PACK (76333-264-26) </PackageDescription>
<NDC11Code>76333-0264-01</NDC11Code>
<ProductNDC>76333-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210729</ApplicationNumber>
<LabelerName>Orient Pharma Co.,Ltd Yunlin Plant</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) : 1 C. difficile -associated diarrhea , 2 Enterocolitis caused by Staphylococcus aureus (including methicillin- resistant strains) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The capsules contain 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride).These capsules also contain polyethylene glycol 6000, FD&C Yellow No. 5, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate and gelatin. The capsules contain 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, yellow iron oxide, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate, gelatin. Both 125 mg and 250 mg capsules are imprinted with ink which may contain titanium dioxide, carnauba wax, white shellac, glyceryl monooleate. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>76333-264-17</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (76333-264-17) </PackageDescription>
<NDC11Code>76333-0264-17</NDC11Code>
<ProductNDC>76333-264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210729</ApplicationNumber>
<LabelerName>Orient Pharma Co.,Ltd Yunlin Plant</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride capsules are glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) : 1 C. difficile -associated diarrhea , 2 Enterocolitis caused by Staphylococcus aureus (including methicillin- resistant strains) .</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ), which has the chemical formula C 66 H 75 Cl 2 N 9 O 24 HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. The capsules contain 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride).These capsules also contain polyethylene glycol 6000, FD&C Yellow No. 5, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate and gelatin. The capsules contain 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). These capsules also contain polyethylene glycol 6000, yellow iron oxide, titanium dioxide, FD&C Blue No. 1, sodium lauryl sulfate, gelatin. Both 125 mg and 250 mg capsules are imprinted with ink which may contain titanium dioxide, carnauba wax, white shellac, glyceryl monooleate. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0006-0568-40</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (0006-0568-40) </PackageDescription>
<NDC11Code>00006-0568-40</NDC11Code>
<ProductNDC>0006-0568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolinza</ProprietaryName>
<NonProprietaryName>Vorinostat</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061006</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021991</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>VORINOSTAT</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLINZA® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.</IndicationAndUsage>
<Description>ZOLINZA contains vorinostat, which is described chemically as N-hydroxy-N'-phenyloctanediamide. The empirical formula is C14H20N2O3. The molecular weight is 264.32 and the structural formula is. Vorinostat is a white to light orange powder. It is very slightly soluble in water, slightly soluble in ethanol, isopropanol and acetone, freely soluble in dimethyl sulfoxide and insoluble in methylene chloride. It has no chiral centers and is non-hygroscopic. The differential scanning calorimetry ranged from 161.7 (endotherm) to 163.9°C. The pH of saturated water solutions of vorinostat drug substance was 6.6. The pKa of vorinostat was determined to be 9.2. Each 100 mg ZOLINZA capsule for oral administration contains 100 mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The capsule shell excipients are titanium dioxide, gelatin and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0009-0046-01</NDCCode>
<PackageDescription>264 VIAL in 1 CONTAINER (0009-0046-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0009-0046-40) </PackageDescription>
<NDC11Code>00009-0046-01</NDC11Code>
<ProductNDC>0009-0046</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Parecoxib Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>PARECOXIB SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-JUL-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0143-9150-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) </PackageDescription>
<NDC11Code>00143-9150-10</NDC11Code>
<ProductNDC>0143-9150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combogesic Iv</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen Injection</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215320</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
<StrengthNumber>1000; 300</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for: the relief of mild to moderate pain the management of moderate to severe pain as an adjunct to opioid analgesicsLimitations of Use COMBOGESIC IV is indicated for short-term use of five days or less.</IndicationAndUsage>
<Description>COMBOGESIC IV (acetaminophen and ibuprofen) injection contains acetaminophen and ibuprofen, a nonsteroidal anti-inflammatory drug. Acetaminophen chemical name is N-acetyl-p-aminophenol. Acetaminophen is a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is soluble in boiling water and 1N sodium hydroxide and is freely soluble in alcohol. Acetaminophen has a molecular weight of 151.16. The molecular formula is C8H9NO2 and the structural formula is. Ibuprofen sodium dihydrate chemical name is 2-(4-isobutyl phenyl) propionic acid sodium salt dihydrate. Ibuprofen sodium dihydrate is a white powder. It has a molecular weight of 264.29. It is freely soluble in water. The molecular formula is C13H21NaO4 and the structural formula of ibuprofen sodium dihydrate is represented below. COMBOGESIC IV injection is a sterile, clear, colorless, non-pyrogenic, isotonic solution, intended for intravenous infusion with a pH stability range of 6.3-7.3. Each single-dose 100 mL vial contains 1,000 mg of acetaminophen and 300 mg of ibuprofen base (equivalent to 385 mg of ibuprofen sodium dihydrate), 25 mg of Cysteine hydrochloride monohydrate, 13 mg of Disodium phosphate dihydrate, 3,285 mg of Mannitol, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injection.</Description>
</NDC>
<NDC>
<NDCCode>0143-9642-01</NDCCode>
<PackageDescription>5 mL in 1 VIAL (0143-9642-01) </PackageDescription>
<NDC11Code>00143-9642-01</NDC11Code>
<ProductNDC>0143-9642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202182</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic acid injection is a bisphosphonate indicated for the treatment of: : 1 Hypercalcemia of malignancy. (1.1) .</IndicationAndUsage>
<Description>Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2 H2O and its molar mass is 290.1 g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic acid injection is available in 5 mL vials as a sterile liquid concentrate solution for intravenous infusion. Each 5 mL concentrate vial contains 4.264 mg zoledronic acid monohydrate, equivalent to 4 mg zoledronic acid on an anhydrous basis, 220 mg of Mannitol, USP, Water for Injection, USP, and 24 mg of Sodium Citrate, USP. Inactive Ingredients: Mannitol, USP, as bulking agent, Water for Injection, and Sodium Citrate, USP, as buffering agent.</Description>
</NDC>
<NDC>
<NDCCode>0409-4215-01</NDCCode>
<PackageDescription>1 VIAL, PLASTIC in 1 CARTON (0409-4215-01) / 5 mL in 1 VIAL, PLASTIC</PackageDescription>
<NDC11Code>00409-4215-01</NDC11Code>
<ProductNDC>0409-4215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoledronic Acid</ProprietaryName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090621</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 1 Hypercalcemia of malignancy. (1.1), 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2).</IndicationAndUsage>
<Description>Zoledronic acid is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is a white crystalline powder. Its molecular formula is C5H10N2O7P2∙H2O and its molar mass is 290.1 g/mol. Zoledronic acid is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronic acid in water is approximately 2.0. Zoledronic acid is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. : 1 Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and sodium citrate, to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0615-8434-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-8434-39) </PackageDescription>
<NDC11Code>00615-8434-39</NDC11Code>
<ProductNDC>0615-8434</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202330</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2.HCl is represented by the following structural formula. Buspirone hydrochloride tablets, USP for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg and 27.4 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0904-6899-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-6899-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6899-61</NDC11Code>
<ProductNDC>0904-6899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078888</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
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