{
"NDC": [
{
"NDCCode": "79445-132-71",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (79445-132-71) ",
"NDC11Code": "79445-0132-71",
"ProductNDC": "79445-132",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 1 Liter",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0869-0727-18",
"PackageDescription": "71 g in 1 BOTTLE, SPRAY (0869-0727-18) ",
"NDC11Code": "00869-0727-18",
"ProductNDC": "0869-0727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170807",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "26.49; 132.45; 44.15; 52.98",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170807",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "55319-727-18",
"PackageDescription": "71 g in 1 BOTTLE, SPRAY (55319-727-18) ",
"NDC11Code": "55319-0727-18",
"ProductNDC": "55319-727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170807",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Family Dollar Services, Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "26.49; 132.45; 44.15; 52.98",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170807",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "55319-787-18",
"PackageDescription": "71 g in 1 BOTTLE, SPRAY (55319-787-18) ",
"NDC11Code": "55319-0787-18",
"ProductNDC": "55319-787",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170807",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Family Dollar Services, Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "26.49; 132.45; 44.15; 52.98",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170807",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "79445-125-26",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (79445-125-26) ",
"NDC11Code": "79445-0125-26",
"ProductNDC": "79445-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yellow Usa Corp",
"NonProprietaryName": "Kg Incorporating",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-126-51",
"PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (79445-126-51) ",
"NDC11Code": "79445-0126-51",
"ProductNDC": "79445-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Yellow Usa Corp",
"NonProprietaryName": "Kg Incorporating",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200731",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-127-03",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (79445-127-03) ",
"NDC11Code": "79445-0127-03",
"ProductNDC": "79445-127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 30ml",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-128-06",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (79445-128-06) ",
"NDC11Code": "79445-0128-06",
"ProductNDC": "79445-128",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 60ml",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-129-10",
"PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (79445-129-10) ",
"NDC11Code": "79445-0129-10",
"ProductNDC": "79445-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 100ml",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-130-25",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (79445-130-25) ",
"NDC11Code": "79445-0130-25",
"ProductNDC": "79445-130",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 250ml",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-131-50",
"PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (79445-131-50) ",
"NDC11Code": "79445-0131-50",
"ProductNDC": "79445-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 500ml",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-133-73",
"PackageDescription": "3800 mL in 1 BOTTLE, PLASTIC (79445-133-73) ",
"NDC11Code": "79445-0133-73",
"ProductNDC": "79445-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 1 Galon",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-134-75",
"PackageDescription": "5000 mL in 1 BOTTLE, PLASTIC (79445-134-75) ",
"NDC11Code": "79445-0134-75",
"ProductNDC": "79445-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 5 Liters",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-135-81",
"PackageDescription": "100 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-135-81) ",
"NDC11Code": "79445-0135-81",
"ProductNDC": "79445-135",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 100 Liters",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2020-10-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-136-82",
"PackageDescription": "220 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-136-82) ",
"NDC11Code": "79445-0136-82",
"ProductNDC": "79445-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 220 Liters",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-137-91",
"PackageDescription": "1000 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-137-91) ",
"NDC11Code": "79445-0137-91",
"ProductNDC": "79445-137",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 1000 Liters",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79445-138-95",
"PackageDescription": "25000 L in 1 TANK (79445-138-95) ",
"NDC11Code": "79445-0138-95",
"ProductNDC": "79445-138",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Cristal Prime 25000 Liters",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL; TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "YELLOW USA CORP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"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": "0074-3575-01",
"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": "0074-3779-03",
"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": "0085-1366-03",
"PackageDescription": "5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05) ",
"NDC11Code": "00085-1366-03",
"ProductNDC": "0085-1366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1366-04",
"PackageDescription": "14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05) ",
"NDC11Code": "00085-1366-04",
"ProductNDC": "0085-1366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1381-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00085-1381-01",
"ProductNDC": "0085-1381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022277",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090227",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1417-02",
"PackageDescription": "5 PACKET in 1 CARTON (0085-1417-02) / 1 CAPSULE in 1 PACKET (0085-1417-03) ",
"NDC11Code": "00085-1417-02",
"ProductNDC": "0085-1417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1425-03",
"PackageDescription": "5 PACKET in 1 CARTON (0085-1425-03) / 1 CAPSULE in 1 PACKET (0085-1425-05) ",
"NDC11Code": "00085-1425-03",
"ProductNDC": "0085-1425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1425-04",
"PackageDescription": "14 PACKET in 1 CARTON (0085-1425-04) / 1 CAPSULE in 1 PACKET (0085-1425-05) ",
"NDC11Code": "00085-1425-04",
"ProductNDC": "0085-1425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
},
{
"NDCCode": "0085-1430-03",
"PackageDescription": "5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05) ",
"NDC11Code": "00085-1430-03",
"ProductNDC": "0085-1430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temodar",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19990811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021029",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990811",
"SamplePackage": "N",
"IndicationAndUsage": "TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>79445-132-71</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (79445-132-71) </PackageDescription>
<NDC11Code>79445-0132-71</NDC11Code>
<ProductNDC>79445-132</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 1 Liter</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0869-0727-18</NDCCode>
<PackageDescription>71 g in 1 BOTTLE, SPRAY (0869-0727-18) </PackageDescription>
<NDC11Code>00869-0727-18</NDC11Code>
<ProductNDC>0869-0727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>26.49; 132.45; 44.15; 52.98</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55319-727-18</NDCCode>
<PackageDescription>71 g in 1 BOTTLE, SPRAY (55319-727-18) </PackageDescription>
<NDC11Code>55319-0727-18</NDC11Code>
<ProductNDC>55319-727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Family Dollar Services, Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>26.49; 132.45; 44.15; 52.98</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55319-787-18</NDCCode>
<PackageDescription>71 g in 1 BOTTLE, SPRAY (55319-787-18) </PackageDescription>
<NDC11Code>55319-0787-18</NDC11Code>
<ProductNDC>55319-787</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Family Dollar Services, Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>26.49; 132.45; 44.15; 52.98</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-125-26</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (79445-125-26) </PackageDescription>
<NDC11Code>79445-0125-26</NDC11Code>
<ProductNDC>79445-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yellow Usa Corp</ProprietaryName>
<NonProprietaryName>Kg Incorporating</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-126-51</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, PLASTIC (79445-126-51) </PackageDescription>
<NDC11Code>79445-0126-51</NDC11Code>
<ProductNDC>79445-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Yellow Usa Corp</ProprietaryName>
<NonProprietaryName>Kg Incorporating</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-127-03</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (79445-127-03) </PackageDescription>
<NDC11Code>79445-0127-03</NDC11Code>
<ProductNDC>79445-127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 30ml</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-128-06</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (79445-128-06) </PackageDescription>
<NDC11Code>79445-0128-06</NDC11Code>
<ProductNDC>79445-128</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 60ml</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-129-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, PLASTIC (79445-129-10) </PackageDescription>
<NDC11Code>79445-0129-10</NDC11Code>
<ProductNDC>79445-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 100ml</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-130-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (79445-130-25) </PackageDescription>
<NDC11Code>79445-0130-25</NDC11Code>
<ProductNDC>79445-130</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 250ml</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-131-50</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, PLASTIC (79445-131-50) </PackageDescription>
<NDC11Code>79445-0131-50</NDC11Code>
<ProductNDC>79445-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 500ml</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-133-73</NDCCode>
<PackageDescription>3800 mL in 1 BOTTLE, PLASTIC (79445-133-73) </PackageDescription>
<NDC11Code>79445-0133-73</NDC11Code>
<ProductNDC>79445-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 1 Galon</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-134-75</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE, PLASTIC (79445-134-75) </PackageDescription>
<NDC11Code>79445-0134-75</NDC11Code>
<ProductNDC>79445-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 5 Liters</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-135-81</NDCCode>
<PackageDescription>100 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-135-81) </PackageDescription>
<NDC11Code>79445-0135-81</NDC11Code>
<ProductNDC>79445-135</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 100 Liters</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-136-82</NDCCode>
<PackageDescription>220 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-136-82) </PackageDescription>
<NDC11Code>79445-0136-82</NDC11Code>
<ProductNDC>79445-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 220 Liters</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-137-91</NDCCode>
<PackageDescription>1000 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (79445-137-91) </PackageDescription>
<NDC11Code>79445-0137-91</NDC11Code>
<ProductNDC>79445-137</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 1000 Liters</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79445-138-95</NDCCode>
<PackageDescription>25000 L in 1 TANK (79445-138-95) </PackageDescription>
<NDC11Code>79445-0138-95</NDC11Code>
<ProductNDC>79445-138</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Cristal Prime 25000 Liters</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL; TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>YELLOW USA CORP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</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>
</NDC>
<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>
<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>0074-2440-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-2440-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>00074-2440-03</NDC11Code>
<ProductNDC>0074-2440</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>0074-3575-01</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>0074-3779-03</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>0085-1366-03</NDCCode>
<PackageDescription>5 PACKET in 1 CARTON (0085-1366-03) / 1 CAPSULE in 1 PACKET (0085-1366-05) </PackageDescription>
<NDC11Code>00085-1366-03</NDC11Code>
<ProductNDC>0085-1366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1366-04</NDCCode>
<PackageDescription>14 PACKET in 1 CARTON (0085-1366-04) / 1 CAPSULE in 1 PACKET (0085-1366-05) </PackageDescription>
<NDC11Code>00085-1366-04</NDC11Code>
<ProductNDC>0085-1366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1381-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00085-1381-01</NDC11Code>
<ProductNDC>0085-1381</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022277</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1417-02</NDCCode>
<PackageDescription>5 PACKET in 1 CARTON (0085-1417-02) / 1 CAPSULE in 1 PACKET (0085-1417-03) </PackageDescription>
<NDC11Code>00085-1417-02</NDC11Code>
<ProductNDC>0085-1417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1425-03</NDCCode>
<PackageDescription>5 PACKET in 1 CARTON (0085-1425-03) / 1 CAPSULE in 1 PACKET (0085-1425-05) </PackageDescription>
<NDC11Code>00085-1425-03</NDC11Code>
<ProductNDC>0085-1425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1425-04</NDCCode>
<PackageDescription>14 PACKET in 1 CARTON (0085-1425-04) / 1 CAPSULE in 1 PACKET (0085-1425-05) </PackageDescription>
<NDC11Code>00085-1425-04</NDC11Code>
<ProductNDC>0085-1425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
<NDC>
<NDCCode>0085-1430-03</NDCCode>
<PackageDescription>5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05) </PackageDescription>
<NDC11Code>00085-1430-03</NDC11Code>
<ProductNDC>0085-1430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temodar</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021029</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TEMODAR is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2)Treatment of adults with refractory anaplastic astrocytoma. (1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan or light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMODAR can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMODAR capsules. TEMODAR (temozolomide) capsules for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: 1 TEMODAR 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg)., 2 TEMODAR 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg)., 3 TEMODAR 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg)., 4 TEMODAR 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg)., 5 TEMODAR 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg)., 6 TEMODAR 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).</Description>
</NDC>
</NDCList>