{
"NDC": [
{
"NDCCode": "0703-5079-37",
"PackageDescription": "12 BAG in 1 CARTON (0703-5079-37) > 500 mL in 1 BAG (0703-5079-31)",
"NDC11Code": "00703-5079-37",
"ProductNDC": "0703-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hetastarch",
"NonProprietaryName": "Hetastarch",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090113",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "BA740592",
"LabelerName": "Teva Parenteral Medicines, Inc",
"SubstanceName": "HETASTARCH",
"StrengthNumber": "6",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "0132-0703-36",
"PackageDescription": "37 mL in 1 BOTTLE, WITH APPLICATOR (0132-0703-36) ",
"NDC11Code": "00132-0703-36",
"ProductNDC": "0132-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fleet",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20020510",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "C.B. Fleet Company, Inc.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020510",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of fecal impaction. for relief of occasional constipation. for removal of residue after barium administration."
},
{
"NDCCode": "17224-703-10",
"PackageDescription": "28 TABLET in 1 BOTTLE (17224-703-10) ",
"NDC11Code": "17224-0703-10",
"ProductNDC": "17224-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040555",
"LabelerName": "CALVIN, SCOTT AND COMPANY, INCORPORATED",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20050415",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride Tablet, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Tablets, USP are available as oral tablets containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: corn starch, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, pregelatinized starch, compressible sugar, and FD&C Blue # 1 aluminum lake."
},
{
"NDCCode": "42858-703-03",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03) ",
"NDC11Code": "42858-0703-03",
"ProductNDC": "42858-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180914",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209293",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180914",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Panic disorder (PD), 3 Social anxiety disorder (SAD), 4 Premenstrual dysphoric disorder (PMDD).",
"Description": "Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3∙HCl∙1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Each enteric coated, extended-release tablet contains paroxetine base of 12.5 mg (white tablet), 25 mg (brown tablet), 37.5 mg (orange tablet), which is equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of carboxymethylcellulose sodium, copovidone, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, silicon dioxide, sodium lauryl sulfate, talcum, titanium dioxide, and triethyl citrate. In addition, the 25 mg tablets also contain the following coloring agents: iron oxide black and iron oxide red and the 37.5 mg tablets contain iron oxide red and iron oxide yellow. USP dissolution test is pending."
},
{
"NDCCode": "42858-703-50",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50) ",
"NDC11Code": "42858-0703-50",
"ProductNDC": "42858-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180914",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209293",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180914",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Panic disorder (PD), 3 Social anxiety disorder (SAD), 4 Premenstrual dysphoric disorder (PMDD).",
"Description": "Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3∙HCl∙1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Each enteric coated, extended-release tablet contains paroxetine base of 12.5 mg (white tablet), 25 mg (brown tablet), 37.5 mg (orange tablet), which is equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of carboxymethylcellulose sodium, copovidone, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, silicon dioxide, sodium lauryl sulfate, talcum, titanium dioxide, and triethyl citrate. In addition, the 25 mg tablets also contain the following coloring agents: iron oxide black and iron oxide red and the 37.5 mg tablets contain iron oxide red and iron oxide yellow. USP dissolution test is pending."
},
{
"NDCCode": "59651-703-70",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (59651-703-70) / 70 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "59651-0703-70",
"ProductNDC": "59651-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole Vaginal Gel",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "VAGINAL",
"StartMarketingDate": "20260925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218485",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260925",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.",
"Description": "Metronidazole vaginal gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure. Metronidazole vaginal gel is a gelled, purified water solution, containing metronidazole USP at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 974P, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole USP."
},
{
"NDCCode": "68382-703-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-01) ",
"NDC11Code": "68382-0703-01",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "68382-703-05",
"PackageDescription": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-05) ",
"NDC11Code": "68382-0703-05",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "68382-703-06",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-06) ",
"NDC11Code": "68382-0703-06",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "68382-703-10",
"PackageDescription": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-10) ",
"NDC11Code": "68382-0703-10",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "68382-703-16",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-16) ",
"NDC11Code": "68382-0703-16",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "68382-703-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-703-77) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-703-30) ",
"NDC11Code": "68382-0703-77",
"ProductNDC": "68382-703",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).",
"Description": "Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc."
},
{
"NDCCode": "0006-5087-01",
"PackageDescription": "1 KIT in 1 CARTON (0006-5087-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89) ",
"NDC11Code": "00006-5087-01",
"ProductNDC": "0006-5087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Winrevair",
"NonProprietaryName": "Sotatercept-csrk",
"DosageFormName": "KIT",
"StartMarketingDate": "20240326",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761363",
"LabelerName": "Merck Sharp & Dohme LLC",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240326",
"SamplePackage": "N",
"IndicationAndUsage": "WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1)].",
"Description": "Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer. Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution. Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL. Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL."
},
{
"NDCCode": "0006-5090-01",
"PackageDescription": "1 KIT in 1 CARTON (0006-5090-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89) ",
"NDC11Code": "00006-5090-01",
"ProductNDC": "0006-5090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Winrevair",
"NonProprietaryName": "Sotatercept-csrk",
"DosageFormName": "KIT",
"StartMarketingDate": "20240326",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761363",
"LabelerName": "Merck Sharp & Dohme LLC",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240326",
"SamplePackage": "N",
"IndicationAndUsage": "WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1)].",
"Description": "Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer. Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution. Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL. Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL."
},
{
"NDCCode": "48951-5079-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-5079-2) ",
"NDC11Code": "48951-5079-02",
"ProductNDC": "48951-5079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyoscyamus 2 Special Order",
"NonProprietaryName": "Hyoscyamus 2 Special Order",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "HYOSCYAMUS NIGER LEAF",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: FOR ORAL USE ONLY."
},
{
"NDCCode": "50090-5079-0",
"PackageDescription": "1 TUBE in 1 CARTON (50090-5079-0) / 15 g in 1 TUBE",
"NDC11Code": "50090-5079-00",
"ProductNDC": "50090-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210034",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200617",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Cream USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid monohydrate, glycol stearate, lanolin liquid, methylparaben, PEG-400 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH."
},
{
"NDCCode": "51927-5079-0",
"PackageDescription": "1 g in 1 BOTTLE (51927-5079-0) ",
"NDC11Code": "51927-5079-00",
"ProductNDC": "51927-5079",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210127",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Professional Compounding Centers of America",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "27-JAN-21"
},
{
"NDCCode": "54868-5079-0",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (54868-5079-0)",
"NDC11Code": "54868-5079-00",
"ProductNDC": "54868-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076211",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red."
},
{
"NDCCode": "54868-5079-1",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (54868-5079-1)",
"NDC11Code": "54868-5079-01",
"ProductNDC": "54868-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076211",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red."
},
{
"NDCCode": "54868-5079-2",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (54868-5079-2)",
"NDC11Code": "54868-5079-02",
"ProductNDC": "54868-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076211",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.",
"Description": "Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red."
},
{
"NDCCode": "55154-5079-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-5079-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-5079-00",
"ProductNDC": "55154-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076578",
"LabelerName": "Cardinal Health",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20070501",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5079-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5079-0)",
"NDC11Code": "62670-5079-00",
"ProductNDC": "62670-5079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Strawberry Fields",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160706",
"EndMarketingDate": "20170106",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "68071-5079-4",
"PackageDescription": "4 mL in 1 BOTTLE, DROPPER (68071-5079-4) ",
"NDC11Code": "68071-5079-04",
"ProductNDC": "68071-5079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracaine Hydrochloride",
"NonProprietaryName": "Tetracaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20161026",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208135",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191009",
"SamplePackage": "N",
"IndicationAndUsage": "Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.",
"Description": "Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15H 24N 2O 2 HCl and it is represented by the chemical structure:. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5. Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP."
},
{
"NDCCode": "82969-5079-1",
"PackageDescription": "30 [hp_C] in 1 BOTTLE, GLASS (82969-5079-1) ",
"NDC11Code": "82969-5079-01",
"ProductNDC": "82969-5079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bestmade Natural Products Nux Vomica",
"NonProprietaryName": "Nux Vomica",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Bestmade Natural Products",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/30[hp_C]",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Best for. Temporarily relieves occasional vomiting and nausea.*."
},
{
"NDCCode": "85816-5079-1",
"PackageDescription": "30000 mg in 1 BOTTLE, GLASS (85816-5079-1) ",
"NDC11Code": "85816-5079-01",
"ProductNDC": "85816-5079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bm Nux Vomica",
"NonProprietaryName": "Nux Vomica",
"DosageFormName": "GLOBULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BM Private Limited",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1000mg",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Indications & dosage: Referred to enclosed self help guide or as advised by a homoeopathic physician."
},
{
"NDCCode": "0113-0703-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-0703-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "00113-0703-26",
"ProductNDC": "0113-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Tussin Cf",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 200; 10",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "0113-0703-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-0703-34) > 237 mL in 1 BOTTLE",
"NDC11Code": "00113-0703-34",
"ProductNDC": "0113-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Tussin Cf",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140729",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 200; 10",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140729",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "0135-0703-01",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-01) / 96.4 g in 1 TUBE",
"NDC11Code": "00135-0703-01",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0135-0703-02",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-02) / 62.5 g in 1 TUBE",
"NDC11Code": "00135-0703-02",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0135-0703-05",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0703-05) / 156 g in 1 TUBE",
"NDC11Code": "00135-0703-05",
"ProductNDC": "0135-0703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne",
"ProprietaryNameSuffix": "Clinical White Enamel Strengthening",
"NonProprietaryName": "Potassium Nitrate, Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 2.5",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0703-5079-37</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0703-5079-37) > 500 mL in 1 BAG (0703-5079-31)</PackageDescription>
<NDC11Code>00703-5079-37</NDC11Code>
<ProductNDC>0703-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hetastarch</ProprietaryName>
<NonProprietaryName>Hetastarch</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090113</StartMarketingDate>
<EndMarketingDate>20140930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>BA740592</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc</LabelerName>
<SubstanceName>HETASTARCH</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0132-0703-36</NDCCode>
<PackageDescription>37 mL in 1 BOTTLE, WITH APPLICATOR (0132-0703-36) </PackageDescription>
<NDC11Code>00132-0703-36</NDC11Code>
<ProductNDC>0132-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fleet</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20020510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>C.B. Fleet Company, Inc.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of fecal impaction. for relief of occasional constipation. for removal of residue after barium administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17224-703-10</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (17224-703-10) </PackageDescription>
<NDC11Code>17224-0703-10</NDC11Code>
<ProductNDC>17224-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040555</ApplicationNumber>
<LabelerName>CALVIN, SCOTT AND COMPANY, INCORPORATED</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride Tablet, USP is a sympathomimetic amine anorectic. Its chemical name is α,α,dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine Hydrochloride Tablets, USP are available as oral tablets containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: corn starch, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, pregelatinized starch, compressible sugar, and FD&C Blue # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>42858-703-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03) </PackageDescription>
<NDC11Code>42858-0703-03</NDC11Code>
<ProductNDC>42858-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180914</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209293</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180914</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Panic disorder (PD), 3 Social anxiety disorder (SAD), 4 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3∙HCl∙1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Each enteric coated, extended-release tablet contains paroxetine base of 12.5 mg (white tablet), 25 mg (brown tablet), 37.5 mg (orange tablet), which is equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of carboxymethylcellulose sodium, copovidone, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, silicon dioxide, sodium lauryl sulfate, talcum, titanium dioxide, and triethyl citrate. In addition, the 25 mg tablets also contain the following coloring agents: iron oxide black and iron oxide red and the 37.5 mg tablets contain iron oxide red and iron oxide yellow. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>42858-703-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50) </PackageDescription>
<NDC11Code>42858-0703-50</NDC11Code>
<ProductNDC>42858-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180914</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209293</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180914</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine Extended-Release Tablets, USP are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Panic disorder (PD), 3 Social anxiety disorder (SAD), 4 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Paroxetine Extended-Release Tablets, USP contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3∙HCl∙1/2H2O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Each enteric coated, extended-release tablet contains paroxetine base of 12.5 mg (white tablet), 25 mg (brown tablet), 37.5 mg (orange tablet), which is equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of carboxymethylcellulose sodium, copovidone, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, silicon dioxide, sodium lauryl sulfate, talcum, titanium dioxide, and triethyl citrate. In addition, the 25 mg tablets also contain the following coloring agents: iron oxide black and iron oxide red and the 37.5 mg tablets contain iron oxide red and iron oxide yellow. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>59651-703-70</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (59651-703-70) / 70 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>59651-0703-70</NDC11Code>
<ProductNDC>59651-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole Vaginal Gel</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20260925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218485</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells. Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus should be ruled out.</IndicationAndUsage>
<Description>Metronidazole vaginal gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure. Metronidazole vaginal gel is a gelled, purified water solution, containing metronidazole USP at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 974P, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole USP.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-01) </PackageDescription>
<NDC11Code>68382-0703-01</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-05</NDCCode>
<PackageDescription>500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-05) </PackageDescription>
<NDC11Code>68382-0703-05</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-06</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-06) </PackageDescription>
<NDC11Code>68382-0703-06</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-10</NDCCode>
<PackageDescription>1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-10) </PackageDescription>
<NDC11Code>68382-0703-10</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-16</NDCCode>
<PackageDescription>90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-703-16) </PackageDescription>
<NDC11Code>68382-0703-16</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>68382-703-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-703-77) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-703-30) </PackageDescription>
<NDC11Code>68382-0703-77</NDC11Code>
<ProductNDC>68382-703</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride orally disintegrating tablets are sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1). The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1).</IndicationAndUsage>
<Description>Phentermine hydrochloride tablet is an orally disintegrating tablet (ODT) of phentermine hydrochloride. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C 10H 15 N. HCl M.W. 185.69. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as an orally disintegrating tablet (ODT) containing 15 mg, 30 mg, or 37.5 mg of phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg of phentermine base). In addition each tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, povidone, silicon dioxide, sodium lauryl sulfate, sodium stearyl fumarate, sucralose and talc.</Description>
</NDC>
<NDC>
<NDCCode>0006-5087-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0006-5087-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89) </PackageDescription>
<NDC11Code>00006-5087-01</NDC11Code>
<ProductNDC>0006-5087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Winrevair</ProprietaryName>
<NonProprietaryName>Sotatercept-csrk</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240326</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761363</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer. Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution. Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL. Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL.</Description>
</NDC>
<NDC>
<NDCCode>0006-5090-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0006-5090-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89) </PackageDescription>
<NDC11Code>00006-5090-01</NDC11Code>
<ProductNDC>0006-5090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Winrevair</ProprietaryName>
<NonProprietaryName>Sotatercept-csrk</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240326</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761363</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Sotatercept-csrk is a homodimeric recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA (ActRIIA) linked to the human IgG1 Fc domain. The molecular weight based on the amino acid sequence of sotatercept-csrk is approximately 78 kDa as a homodimer. Sotatercept-csrk for injection is a sterile, preservative-free, white to off-white lyophilized cake or powder appearance in single-dose vials for subcutaneous administration after reconstitution. Each 45 mg single-dose vial provides 45 mg of sotatercept-csrk and citric acid monohydrate (0.40 mg), polysorbate 80 (0.18 mg), sodium citrate (1.84 mg), and sucrose (72 mg) at pH 5.8. After reconstitution with 1 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 0.9 mL. Each 60 mg single-dose vial provides 60 mg of sotatercept-csrk and citric acid monohydrate (0.53 mg), polysorbate 80 (0.24 mg), sodium citrate (2.45 mg), and sucrose (96 mg) at pH 5.8. After reconstitution with 1.3 mL Sterile Water for Injection, the resulting concentration is 50 mg/mL of sotatercept-csrk and the nominal deliverable volume is 1.2 mL.</Description>
</NDC>
<NDC>
<NDCCode>48951-5079-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-5079-2) </PackageDescription>
<NDC11Code>48951-5079-02</NDC11Code>
<ProductNDC>48951-5079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamus 2 Special Order</ProprietaryName>
<NonProprietaryName>Hyoscyamus 2 Special Order</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>HYOSCYAMUS NIGER LEAF</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-5079-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (50090-5079-0) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>50090-5079-00</NDC11Code>
<ProductNDC>50090-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210034</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Cream USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid monohydrate, glycol stearate, lanolin liquid, methylparaben, PEG-400 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>51927-5079-0</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (51927-5079-0) </PackageDescription>
<NDC11Code>51927-5079-00</NDC11Code>
<ProductNDC>51927-5079</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Desmopressin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210127</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Professional Compounding Centers of America</LabelerName>
<SubstanceName>DESMOPRESSIN ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-JAN-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>54868-5079-0</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (54868-5079-0)</PackageDescription>
<NDC11Code>54868-5079-00</NDC11Code>
<ProductNDC>54868-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076211</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>54868-5079-1</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (54868-5079-1)</PackageDescription>
<NDC11Code>54868-5079-01</NDC11Code>
<ProductNDC>54868-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076211</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>54868-5079-2</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (54868-5079-2)</PackageDescription>
<NDC11Code>54868-5079-02</NDC11Code>
<ProductNDC>54868-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076211</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks.</IndicationAndUsage>
<Description>Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. C24H28N2O5HCl M.W. 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>55154-5079-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-5079-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-5079-00</NDC11Code>
<ProductNDC>55154-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076578</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5079-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5079-0)</PackageDescription>
<NDC11Code>62670-5079-00</NDC11Code>
<ProductNDC>62670-5079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Strawberry Fields</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160706</StartMarketingDate>
<EndMarketingDate>20170106</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>68071-5079-4</NDCCode>
<PackageDescription>4 mL in 1 BOTTLE, DROPPER (68071-5079-4) </PackageDescription>
<NDC11Code>68071-5079-04</NDC11Code>
<ProductNDC>68071-5079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20161026</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208135</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.</IndicationAndUsage>
<Description>Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C 15H 24N 2O 2 HCl and it is represented by the chemical structure:. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5. Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>82969-5079-1</NDCCode>
<PackageDescription>30 [hp_C] in 1 BOTTLE, GLASS (82969-5079-1) </PackageDescription>
<NDC11Code>82969-5079-01</NDC11Code>
<ProductNDC>82969-5079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bestmade Natural Products Nux Vomica</ProprietaryName>
<NonProprietaryName>Nux Vomica</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Bestmade Natural Products</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Best for. Temporarily relieves occasional vomiting and nausea.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85816-5079-1</NDCCode>
<PackageDescription>30000 mg in 1 BOTTLE, GLASS (85816-5079-1) </PackageDescription>
<NDC11Code>85816-5079-01</NDC11Code>
<ProductNDC>85816-5079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bm Nux Vomica</ProprietaryName>
<NonProprietaryName>Nux Vomica</NonProprietaryName>
<DosageFormName>GLOBULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BM Private Limited</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1000mg</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications & dosage: Referred to enclosed self help guide or as advised by a homoeopathic physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-0703-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0703-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0703-26</NDC11Code>
<ProductNDC>0113-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Tussin Cf</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 200; 10</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140729</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-0703-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0703-34) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0703-34</NDC11Code>
<ProductNDC>0113-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Tussin Cf</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140729</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20; 200; 10</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. temporarily relieves these symptoms occurring with a cold:. nasal congestion. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-01) / 96.4 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-01</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-02) / 62.5 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-02</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0135-0703-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0135-0703-05) / 156 g in 1 TUBE</PackageDescription>
<NDC11Code>00135-0703-05</NDC11Code>
<ProductNDC>0135-0703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sensodyne</ProprietaryName>
<ProprietaryNameSuffix>Clinical White Enamel Strengthening</ProprietaryNameSuffix>
<NonProprietaryName>Potassium Nitrate, Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>POTASSIUM NITRATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>50; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
</NDCList>