{
"NDC": [
{
"NDCCode": "72888-203-00",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (72888-203-00) ",
"NDC11Code": "72888-0203-00",
"ProductNDC": "72888-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075229",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260918",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "72888-203-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (72888-203-01) ",
"NDC11Code": "72888-0203-01",
"ProductNDC": "72888-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075229",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260918",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "72888-203-05",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (72888-203-05) ",
"NDC11Code": "72888-0203-05",
"ProductNDC": "72888-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075229",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260918",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "72888-203-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (72888-203-30) ",
"NDC11Code": "72888-0203-30",
"ProductNDC": "72888-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075229",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260918",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide."
},
{
"NDCCode": "42507-203-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (42507-203-26) / 118 mL in 1 BOTTLE (42507-203-00) ",
"NDC11Code": "42507-0203-26",
"ProductNDC": "42507-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens All Day Allergy",
"NonProprietaryName": "Cetirizine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204226",
"LabelerName": "HyVee Inc",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140217",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "51389-203-00",
"PackageDescription": "1 TUBE in 1 PACKAGE (51389-203-00) > 59 mL in 1 TUBE",
"NDC11Code": "51389-0203-00",
"ProductNDC": "51389-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Geller Beauty Tuscan Sun Spackle Spf 30 Protective Under Make-up Primer Tan",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Geller Beauty, LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "30; 75; 50",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"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": "51634-203-00",
"PackageDescription": "75 kg in 1 DRUM (51634-203-00)",
"NDC11Code": "51634-0203-00",
"ProductNDC": "51634-203",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19940520",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Noramco, Inc.",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "53675-203-00",
"PackageDescription": "30 mL in 1 CONTAINER (53675-203-00) ",
"NDC11Code": "53675-0203-00",
"ProductNDC": "53675-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Broad Spectrum Spf50 Water Resistant 80 Minutes Mineral Sunscreen Uva Uvb Protection Stick",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220308",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Aruba Aloe Balm NV",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220308",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun."
},
{
"NDCCode": "59448-203-00",
"PackageDescription": "1 KIT in 1 BAG (59448-203-00) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE",
"NDC11Code": "59448-0203-00",
"ProductNDC": "59448-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Northside Hospital C-section Mothers Bag",
"NonProprietaryName": "Alcohol And Sodium Monofluorophospate",
"DosageFormName": "KIT",
"StartMarketingDate": "20170415",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "ASP Global, LLc",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170415",
"SamplePackage": "N"
},
{
"NDCCode": "61197-203-00",
"PackageDescription": "1 BOTTLE, PUMP in 1 BOX (61197-203-00) > 30 mL in 1 BOTTLE, PUMP",
"NDC11Code": "61197-0203-00",
"ProductNDC": "61197-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pacifica Ultra Cc Radiant Foundation Broad Spectrum Spf 17",
"ProprietaryNameSuffix": "Warm Medium",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Pacifica Beauty LLC.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "114",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210101",
"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": "61722-203-00",
"PackageDescription": "1 BOTTLE in 1 BOX (61722-203-00) > 30 mL in 1 BOTTLE",
"NDC11Code": "61722-0203-00",
"ProductNDC": "61722-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flormar Reborn Foundation Sunscreen Broad Spectrum Spf 20 Sf10 Classic Beige",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140704",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kosan Kozmetik Sanayi ve Ticaret A.S.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140704",
"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": "63187-203-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (63187-203-00) ",
"NDC11Code": "63187-0203-00",
"ProductNDC": "63187-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram Hydrobromide",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151102",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Citalopram HBr, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide."
},
{
"NDCCode": "63552-203-00",
"PackageDescription": "1440 SYRINGE, PLASTIC in 1 CASE (63552-203-00) / .5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "63552-0203-00",
"ProductNDC": "63552-203",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20210605",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1.7",
"StrengthUnit": "mg/.75mL",
"Status": "Unfinished",
"LastUpdate": "2024-11-05",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-JUN-21"
},
{
"NDCCode": "65267-203-00",
"PackageDescription": "75 kg in 1 DRUM (65267-203-00) ",
"NDC11Code": "65267-0203-00",
"ProductNDC": "65267-203",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120430",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Janssen Pharmaceutical Sciences Unlimited Company",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CIII",
"Status": "Unfinished",
"LastUpdate": "2024-12-19",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-APR-12"
},
{
"NDCCode": "68754-203-00",
"PackageDescription": "171.1 g in 1 BOX (68754-203-00) ",
"NDC11Code": "68754-0203-00",
"ProductNDC": "68754-203",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "AEROSOL, SPRAY",
"StartMarketingDate": "20171227",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "American Spraytech, LLC",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-12-19",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "27-DEC-17"
},
{
"NDCCode": "70281-203-00",
"PackageDescription": "28.35 g in 1 CONTAINER (70281-203-00) ",
"NDC11Code": "70281-0203-00",
"ProductNDC": "70281-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Op Spf45 Face Clear Zinc Potion",
"NonProprietaryName": "Octinoxate, Zinc Oxide, Oxybenzone, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SolSkyn Personal Care LLC",
"SubstanceName": "OCTINOXATE; ZINC OXIDE; OXYBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "7.5; 7; 5; 5; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170201",
"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": "71323-203-00",
"PackageDescription": "118 mL in 1 BOTTLE, SPRAY (71323-203-00) ",
"NDC11Code": "71323-0203-00",
"ProductNDC": "71323-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Picklebalm Lidocaine With Menthol Arnica Cucumber Seed",
"NonProprietaryName": "Lidocaine, Menthol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Compass Health Brands Corp.",
"SubstanceName": "LIDOCAINE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40; 10",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain."
},
{
"NDCCode": "75834-203-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (75834-203-00) ",
"NDC11Code": "75834-0203-00",
"ProductNDC": "75834-203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203379",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190125",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide tablets, USP contain glyburide, USP, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound, formulated as Glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients: microcrystalline cellulose, pregelatinized starch (corn starch), sodium starch glycolate (type A potato) and magnesium stearate. In addition, the 2.5 mg contains FD&C yellow No. 6 and the 5 mg contains D&C yellow No. 10, and FD&C blue No. 1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below."
},
{
"NDCCode": "82177-203-00",
"PackageDescription": "177 mL in 1 BOTTLE, SPRAY (82177-203-00) ",
"NDC11Code": "82177-0203-00",
"ProductNDC": "82177-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Get Mr. Butter Body Spf-30",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210810",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biomin LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "60; 60",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210810",
"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": "82757-203-00",
"PackageDescription": "50 mL in 1 BOTTLE (82757-203-00) ",
"NDC11Code": "82757-0203-00",
"ProductNDC": "82757-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Mineral Melt",
"ProprietaryNameSuffix": "Invisible Mineral Suncare For Face",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Dune Suncare, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "23; 48",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"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": "72888-004-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-004-00) ",
"NDC11Code": "72888-0004-00",
"ProductNDC": "72888-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake."
},
{
"NDCCode": "72888-005-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-005-00) ",
"NDC11Code": "72888-0005-00",
"ProductNDC": "72888-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake."
},
{
"NDCCode": "72888-006-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-006-00) ",
"NDC11Code": "72888-0006-00",
"ProductNDC": "72888-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake."
},
{
"NDCCode": "72888-007-00",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (72888-007-00) ",
"NDC11Code": "72888-0007-00",
"ProductNDC": "72888-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N"
},
{
"NDCCode": "72888-008-00",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (72888-008-00) ",
"NDC11Code": "72888-0008-00",
"ProductNDC": "72888-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200224",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol Hydrochloride Tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)] reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .",
"Description": "Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. Then-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets, USP 25 mg, 50 mg, 75 mg and 100 mg contain 25 mg, 50 mg, 75 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "72888-010-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (72888-010-00) ",
"NDC11Code": "72888-0010-00",
"ProductNDC": "72888-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209102",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
},
{
"NDCCode": "72888-011-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (72888-011-00) ",
"NDC11Code": "72888-0011-00",
"ProductNDC": "72888-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209102",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180401",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
},
{
"NDCCode": "72888-012-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00) ",
"NDC11Code": "72888-0012-00",
"ProductNDC": "72888-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
},
{
"NDCCode": "72888-014-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-014-00) ",
"NDC11Code": "72888-0014-00",
"ProductNDC": "72888-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208170",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170531",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake."
},
{
"NDCCode": "72888-016-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-016-00) ",
"NDC11Code": "72888-0016-00",
"ProductNDC": "72888-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204882",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
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"LastUpdate": "2026-01-08",
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"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium."
}
]
}
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide.</Description>
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<Description>Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide.</Description>
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<Description>Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide.</Description>
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<ProductNDC>72888-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 for treatment of primary dysmenorrhea, 2 for relief of mild to moderate pain, 3 for relief of the signs and symptoms of osteoarthritis, 4 for relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25 g/mol. Its molecular formula is C 14H 10C 12NKO 2. The structural formula is:. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg, 50 mg and 75 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide.</Description>
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<PackageDescription>1 BOTTLE in 1 CARTON (42507-203-26) / 118 mL in 1 BOTTLE (42507-203-00) </PackageDescription>
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<ProductNDC>42507-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens All Day Allergy</ProprietaryName>
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204226</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
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<NDCCode>51389-203-00</NDCCode>
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<ProprietaryName>Laura Geller Beauty Tuscan Sun Spackle Spf 30 Protective Under Make-up Primer Tan</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<LabelerName>Laura Geller Beauty, LLC</LabelerName>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<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>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
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<PackageDescription>30 mL in 1 CONTAINER (53675-203-00) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Broad Spectrum Spf50 Water Resistant 80 Minutes Mineral Sunscreen Uva Uvb Protection Stick</ProprietaryName>
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<DosageFormName>STICK</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Aruba Aloe Balm NV</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220308</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 an early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>1 KIT in 1 BAG (59448-203-00) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Northside Hospital C-section Mothers Bag</ProprietaryName>
<NonProprietaryName>Alcohol And Sodium Monofluorophospate</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ASP Global, LLc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<NDC11Code>61197-0203-00</NDC11Code>
<ProductNDC>61197-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ProprietaryNameSuffix>Warm Medium</ProprietaryNameSuffix>
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<LabelerName>Pacifica Beauty LLC.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>114</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</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>
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<PackageDescription>1 BOTTLE in 1 BOX (61722-203-00) > 30 mL in 1 BOTTLE</PackageDescription>
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<ProductNDC>61722-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flormar Reborn Foundation Sunscreen Broad Spectrum Spf 20 Sf10 Classic Beige</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
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<LabelerName>Kosan Kozmetik Sanayi ve Ticaret A.S.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140704</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>
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<NDC>
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<PackageDescription>100 TABLET in 1 BOTTLE (63187-203-00) </PackageDescription>
<NDC11Code>63187-0203-00</NDC11Code>
<ProductNDC>63187-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram HBr is indicated for the treatment of depression. The efficacy of citalopram HBr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Citalopram HBr, USP is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr, USP occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available only in tablet dosage form. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63552-203-00</NDCCode>
<PackageDescription>1440 SYRINGE, PLASTIC in 1 CASE (63552-203-00) / .5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>63552-0203-00</NDC11Code>
<ProductNDC>63552-203</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Semaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20210605</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Patheon Manufacturing Services LLC</LabelerName>
<SubstanceName>SEMAGLUTIDE</SubstanceName>
<StrengthNumber>1.7</StrengthNumber>
<StrengthUnit>mg/.75mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-11-05</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-JUN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65267-203-00</NDCCode>
<PackageDescription>75 kg in 1 DRUM (65267-203-00) </PackageDescription>
<NDC11Code>65267-0203-00</NDC11Code>
<ProductNDC>65267-203</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120430</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Janssen Pharmaceutical Sciences Unlimited Company</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2024-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-APR-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68754-203-00</NDCCode>
<PackageDescription>171.1 g in 1 BOX (68754-203-00) </PackageDescription>
<NDC11Code>68754-0203-00</NDC11Code>
<ProductNDC>68754-203</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<StartMarketingDate>20171227</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>American Spraytech, LLC</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-19</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-DEC-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70281-203-00</NDCCode>
<PackageDescription>28.35 g in 1 CONTAINER (70281-203-00) </PackageDescription>
<NDC11Code>70281-0203-00</NDC11Code>
<ProductNDC>70281-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Op Spf45 Face Clear Zinc Potion</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide, Oxybenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SolSkyn Personal Care LLC</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE; OXYBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>7.5; 7; 5; 5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</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>71323-203-00</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, SPRAY (71323-203-00) </PackageDescription>
<NDC11Code>71323-0203-00</NDC11Code>
<ProductNDC>71323-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Picklebalm Lidocaine With Menthol Arnica Cucumber Seed</ProprietaryName>
<NonProprietaryName>Lidocaine, Menthol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Compass Health Brands Corp.</LabelerName>
<SubstanceName>LIDOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75834-203-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (75834-203-00) </PackageDescription>
<NDC11Code>75834-0203-00</NDC11Code>
<ProductNDC>75834-203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203379</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide tablets, USP contain glyburide, USP, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound, formulated as Glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients: microcrystalline cellulose, pregelatinized starch (corn starch), sodium starch glycolate (type A potato) and magnesium stearate. In addition, the 2.5 mg contains FD&C yellow No. 6 and the 5 mg contains D&C yellow No. 10, and FD&C blue No. 1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>82177-203-00</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, SPRAY (82177-203-00) </PackageDescription>
<NDC11Code>82177-0203-00</NDC11Code>
<ProductNDC>82177-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Get Mr. Butter Body Spf-30</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210810</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biomin LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>60; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210810</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>82757-203-00</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (82757-203-00) </PackageDescription>
<NDC11Code>82757-0203-00</NDC11Code>
<ProductNDC>82757-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Mineral Melt</ProprietaryName>
<ProprietaryNameSuffix>Invisible Mineral Suncare For Face</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Dune Suncare, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>23; 48</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</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>72888-004-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-004-00) </PackageDescription>
<NDC11Code>72888-0004-00</NDC11Code>
<ProductNDC>72888-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72888-005-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-005-00) </PackageDescription>
<NDC11Code>72888-0005-00</NDC11Code>
<ProductNDC>72888-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72888-006-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-006-00) </PackageDescription>
<NDC11Code>72888-0006-00</NDC11Code>
<ProductNDC>72888-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D&C Red #30 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72888-007-00</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (72888-007-00) </PackageDescription>
<NDC11Code>72888-0007-00</NDC11Code>
<ProductNDC>72888-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72888-008-00</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (72888-008-00) </PackageDescription>
<NDC11Code>72888-0008-00</NDC11Code>
<ProductNDC>72888-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol Hydrochloride Tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)] reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. .</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. Then-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets, USP 25 mg, 50 mg, 75 mg and 100 mg contain 25 mg, 50 mg, 75 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72888-010-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (72888-010-00) </PackageDescription>
<NDC11Code>72888-0010-00</NDC11Code>
<ProductNDC>72888-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209102</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-011-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (72888-011-00) </PackageDescription>
<NDC11Code>72888-0011-00</NDC11Code>
<ProductNDC>72888-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209102</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-012-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00) </PackageDescription>
<NDC11Code>72888-0012-00</NDC11Code>
<ProductNDC>72888-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72888-014-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-014-00) </PackageDescription>
<NDC11Code>72888-0014-00</NDC11Code>
<ProductNDC>72888-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208170</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-(5H -dibenzo[a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride tablets, USP are available as 5 mg, 7.5 mg and 10 mg tablets for oral administration. Each 5 mg, 7.5 mg and 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide. The tablets of 5 mg and 10 mg also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake. In addition, the 5 mg tablets contain FD&C Blue #2/INDIGO Carmine Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72888-016-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (72888-016-00) </PackageDescription>
<NDC11Code>72888-0016-00</NDC11Code>
<ProductNDC>72888-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204882</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H- pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium.</Description>
</NDC>
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