{
"NDC": [
{
"NDCCode": "0378-2260-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-2260-10)",
"NDC11Code": "00378-2260-10",
"ProductNDC": "0378-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin Hydrochloride Anhydrous",
"NonProprietaryName": "Terazosin Hydrochloride Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075140",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "0378-2260-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2260-01) ",
"NDC11Code": "00378-2260-01",
"ProductNDC": "0378-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin Hydrochloride Anhydrous",
"NonProprietaryName": "Terazosin Hydrochloride Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075140",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20000222",
"SamplePackage": "N"
},
{
"NDCCode": "0143-2260-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0143-2260-10) ",
"NDC11Code": "00143-2260-10",
"ProductNDC": "0143-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060330",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076813",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060330",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "36987-2260-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2260-2)",
"NDC11Code": "36987-2260-02",
"ProductNDC": "36987-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sisal",
"NonProprietaryName": "Sisal",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGAVE SISALANA FIBER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "67296-2260-1",
"PackageDescription": "10 TABLET in 1 BOTTLE (67296-2260-1) ",
"NDC11Code": "67296-2260-01",
"ProductNDC": "67296-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091368",
"LabelerName": "Redpharm Drug",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160503",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate and FD&C Yellow No. 6 Aluminum Lake. Clonidine hydrochloride 0.1 mg tablets also contain FD&C Red No. 40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C 9H 9Cl 2N 3.HCl Mol Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "0069-2260-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-2260-30) ",
"NDC11Code": "00069-2260-30",
"ProductNDC": "0069-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caduet",
"NonProprietaryName": "Amlodipine Besylate And Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021540",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040130",
"SamplePackage": "N",
"IndicationAndUsage": "CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.",
"Description": "CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca∙3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium."
},
{
"NDCCode": "0781-2260-22",
"PackageDescription": "2000 CAPSULE in 1 BOTTLE (0781-2260-22)",
"NDC11Code": "00781-2260-22",
"ProductNDC": "0781-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "0781-2260-31",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0781-2260-31)",
"NDC11Code": "00781-2260-31",
"ProductNDC": "0781-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine Hydrochloride",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079018",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
"Description": "Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac."
},
{
"NDCCode": "11054-041-03",
"PackageDescription": "2260 L in 1 CYLINDER (11054-041-03) ",
"NDC11Code": "11054-0041-03",
"ProductNDC": "11054-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium, Oxygen",
"NonProprietaryName": "Helium, Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205843",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "800; 200",
"StrengthUnit": "mL/L; mL/L",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971014",
"SamplePackage": "N"
},
{
"NDCCode": "11054-042-03",
"PackageDescription": "2260 L in 1 CYLINDER (11054-042-03) ",
"NDC11Code": "11054-0042-03",
"ProductNDC": "11054-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium, Oxygen",
"NonProprietaryName": "Helium, Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971014",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA205843",
"LabelerName": "AIRGAS USA, LLC",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "600; 400",
"StrengthUnit": "mL/L; mL/L",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971014",
"SamplePackage": "N"
},
{
"NDCCode": "50090-2260-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2260-0) ",
"NDC11Code": "50090-2260-00",
"ProductNDC": "50090-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-2260-1",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2260-1) ",
"NDC11Code": "50090-2260-01",
"ProductNDC": "50090-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-2260-3",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-2260-3) ",
"NDC11Code": "50090-2260-03",
"ProductNDC": "50090-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "50090-2260-4",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (50090-2260-4) ",
"NDC11Code": "50090-2260-04",
"ProductNDC": "50090-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151209",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "53002-2260-4",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (53002-2260-4) ",
"NDC11Code": "53002-2260-04",
"ProductNDC": "53002-2260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065229",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: : 1 Respiratory tract infection (1.1), 2 Otitis media (1.2), 3 Skin and skin structure infections (1.3), 4 Bone infections (1.4), 5 Genitourinary tract infections (1.5).",
"Description": "Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "0173-0378-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00173-0378-10",
"ProductNDC": "0173-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fortaz",
"NonProprietaryName": "Ceftazidime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20041213",
"EndMarketingDate": "20140420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050578",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "CEFTAZIDIME SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-04-28"
},
{
"NDCCode": "0378-0032-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) ",
"NDC11Code": "00378-0032-10",
"ProductNDC": "0378-0032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0047-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) ",
"NDC11Code": "00378-0047-10",
"ProductNDC": "0378-0047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19931223",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "0378-0078-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)",
"NDC11Code": "00378-0078-10",
"ProductNDC": "0378-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090324",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0378-0080-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-10) ",
"NDC11Code": "00378-0080-10",
"ProductNDC": "0378-0080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indapamide",
"NonProprietaryName": "Indapamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074461",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "INDAPAMIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19960328",
"SamplePackage": "N",
"IndicationAndUsage": "Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.",
"Description": "Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin."
},
{
"NDCCode": "0378-0085-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0085-10)",
"NDC11Code": "00378-0085-10",
"ProductNDC": "0378-0085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090324",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "0378-0137-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0378-0137-10) ",
"NDC11Code": "00378-0137-10",
"ProductNDC": "0378-0137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA018659",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19861024",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0143-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-10) ",
"NDC11Code": "00378-0143-10",
"ProductNDC": "0378-0143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840420",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018858",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840420",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0152-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0152-10) ",
"NDC11Code": "00378-0152-10",
"ProductNDC": "0378-0152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870609",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070317",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19870609",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0182-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0182-10) ",
"NDC11Code": "00378-0182-10",
"ProductNDC": "0378-0182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0183-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0183-10) ",
"NDC11Code": "00378-0183-10",
"ProductNDC": "0378-0183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0184-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0184-10) ",
"NDC11Code": "00378-0184-10",
"ProductNDC": "0378-0184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070213",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19851119",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake."
},
{
"NDCCode": "0378-0186-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0186-10) ",
"NDC11Code": "00378-0186-10",
"ProductNDC": "0378-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19870609",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070317",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19870609",
"EndMarketingDatePackage": "20200930",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0208-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0208-10) ",
"NDC11Code": "00378-0208-10",
"ProductNDC": "0378-0208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810827",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19810827",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "0378-0213-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0378-0213-10) ",
"NDC11Code": "00378-0213-10",
"ProductNDC": "0378-0213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086831",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19810226",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0378-2260-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-2260-10)</PackageDescription>
<NDC11Code>00378-2260-10</NDC11Code>
<ProductNDC>0378-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin Hydrochloride Anhydrous</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075140</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-2260-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2260-01) </PackageDescription>
<NDC11Code>00378-2260-01</NDC11Code>
<ProductNDC>0378-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin Hydrochloride Anhydrous</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075140</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0143-2260-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0143-2260-10) </PackageDescription>
<NDC11Code>00143-2260-10</NDC11Code>
<ProductNDC>0143-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060330</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076813</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060330</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36987-2260-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2260-2)</PackageDescription>
<NDC11Code>36987-2260-02</NDC11Code>
<ProductNDC>36987-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sisal</ProprietaryName>
<NonProprietaryName>Sisal</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGAVE SISALANA FIBER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>67296-2260-1</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (67296-2260-1) </PackageDescription>
<NDC11Code>67296-2260-01</NDC11Code>
<ProductNDC>67296-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091368</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate and FD&C Yellow No. 6 Aluminum Lake. Clonidine hydrochloride 0.1 mg tablets also contain FD&C Red No. 40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C 9H 9Cl 2N 3.HCl Mol Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0069-2260-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-2260-30) </PackageDescription>
<NDC11Code>00069-2260-30</NDC11Code>
<ProductNDC>0069-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caduet</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021540</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.</IndicationAndUsage>
<Description>CADUET (amlodipine and atorvastatin) tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca∙3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. CADUET contains amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. CADUET is available as film-coated tablets containing: 1 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 2 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 3 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 5 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 6 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 7 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>0781-2260-22</NDCCode>
<PackageDescription>2000 CAPSULE in 1 BOTTLE (0781-2260-22)</PackageDescription>
<NDC11Code>00781-2260-22</NDC11Code>
<ProductNDC>0781-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0781-2260-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0781-2260-31)</PackageDescription>
<NDC11Code>00781-2260-31</NDC11Code>
<ProductNDC>0781-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079018</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).</IndicationAndUsage>
<Description>Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride capsules are intended for oral administration only. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg of atomoxetine. In addition, each capsule contains the following inactive ingredients: dimethicone and pregelatinized starch. The capsule shell for 10 mg consists of gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 18 mg consists of D&C yellow # 10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 25 mg and 40 mg consists of FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 60 mg consists of D&C yellow # 10, FD&C blue #1, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell for 80 mg and 100 mg consists of D&C yellow #10, FD&C red #3, gelatin, sodium lauryl sulfate and titanium dioxide. Atomoxetine hydrochloride capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg are printed with edible black ink. The black ink is comprised of black iron oxide, propylene glycol, and shellac.</Description>
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<NDC>
<NDCCode>11054-041-03</NDCCode>
<PackageDescription>2260 L in 1 CYLINDER (11054-041-03) </PackageDescription>
<NDC11Code>11054-0041-03</NDC11Code>
<ProductNDC>11054-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium, Oxygen</ProprietaryName>
<NonProprietaryName>Helium, Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205843</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>800; 200</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11054-042-03</NDCCode>
<PackageDescription>2260 L in 1 CYLINDER (11054-042-03) </PackageDescription>
<NDC11Code>11054-0042-03</NDC11Code>
<ProductNDC>11054-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium, Oxygen</ProprietaryName>
<NonProprietaryName>Helium, Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971014</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA205843</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>600; 400</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-2260-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-2260-0) </PackageDescription>
<NDC11Code>50090-2260-00</NDC11Code>
<ProductNDC>50090-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>50090-2260-1</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-2260-1) </PackageDescription>
<NDC11Code>50090-2260-01</NDC11Code>
<ProductNDC>50090-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>50090-2260-3</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-2260-3) </PackageDescription>
<NDC11Code>50090-2260-03</NDC11Code>
<ProductNDC>50090-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>50090-2260-4</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (50090-2260-4) </PackageDescription>
<NDC11Code>50090-2260-04</NDC11Code>
<ProductNDC>50090-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>53002-2260-4</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (53002-2260-4) </PackageDescription>
<NDC11Code>53002-2260-04</NDC11Code>
<ProductNDC>53002-2260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065229</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cephalexin capsules USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: : 1 Respiratory tract infection (1.1), 2 Otitis media (1.2), 3 Skin and skin structure infections (1.3), 4 Bone infections (1.4), 5 Genitourinary tract infections (1.5).</IndicationAndUsage>
<Description>Cephalexin capsules USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7- (D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4SH2O and the molecular weight is 365.41. Cephalexin has the following structural formula. Each capsule contains cephalexin USP equivalent to 250 mg, or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0378-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0173-0378-10) > 26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00173-0378-10</NDC11Code>
<ProductNDC>0173-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fortaz</ProprietaryName>
<NonProprietaryName>Ceftazidime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20041213</StartMarketingDate>
<EndMarketingDate>20140420</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050578</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>CEFTAZIDIME SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0032-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0032-10) </PackageDescription>
<NDC11Code>00378-0032-10</NDC11Code>
<ProductNDC>0378-0032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0047-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0047-10) </PackageDescription>
<NDC11Code>00378-0047-10</NDC11Code>
<ProductNDC>0378-0047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. (1.3).</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg metoprolol tartrate, respectively. Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0078-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0078-10)</PackageDescription>
<NDC11Code>00378-0078-10</NDC11Code>
<ProductNDC>0378-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090324</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0080-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-10) </PackageDescription>
<NDC11Code>00378-0080-10</NDC11Code>
<ProductNDC>0378-0080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indapamide</ProprietaryName>
<NonProprietaryName>Indapamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074461</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDAPAMIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.</IndicationAndUsage>
<Description>Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group. The chemical name of indapamide is 4-Chloro-N-(2-methyl-1-indolinyl)-3-Sulfamoylbenzamide, and its molecular weight is 365.84. The compound is a weak acid, pKa=8.8, and is soluble in aqueous solutions of strong bases. It is a white to yellow-white crystalline (tetragonal) powder. C16H16ClN3O3S. Each tablet, for oral administration, contains 1.25 mg or 2.5 mg of indapamide, USP and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. Additionally, the 1.25 mg product contains glyceryl triacetate and D&C Red No. 30 Aluminum Lake and the 2.5 mg product contains triacetin.</Description>
</NDC>
<NDC>
<NDCCode>0378-0085-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0085-10)</PackageDescription>
<NDC11Code>00378-0085-10</NDC11Code>
<ProductNDC>0378-0085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090324</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0137-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0378-0137-10) </PackageDescription>
<NDC11Code>00378-0137-10</NDC11Code>
<ProductNDC>0378-0137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA018659</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored, white, round tablet contains 100 mg or 300 mg allopurinol, USP and the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-0143-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-0143-10) </PackageDescription>
<NDC11Code>00378-0143-10</NDC11Code>
<ProductNDC>0378-0143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840420</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018858</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19840420</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0152-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0152-10) </PackageDescription>
<NDC11Code>00378-0152-10</NDC11Code>
<ProductNDC>0378-0152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870609</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070317</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19870609</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0182-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0182-10) </PackageDescription>
<NDC11Code>00378-0182-10</NDC11Code>
<ProductNDC>0378-0182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070213</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0183-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0183-10) </PackageDescription>
<NDC11Code>00378-0183-10</NDC11Code>
<ProductNDC>0378-0183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070213</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0184-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0184-10) </PackageDescription>
<NDC11Code>00378-0184-10</NDC11Code>
<ProductNDC>0378-0184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070213</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as (±)-1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolol hydrochloride. Its molecular and structural formulae are. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets are: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 10 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake, the 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, the 40 mg tablets also contain FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake, the 60 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake and the 80 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0378-0186-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0186-10) </PackageDescription>
<NDC11Code>00378-0186-10</NDC11Code>
<ProductNDC>0378-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870609</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070317</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19870609</StartMarketingDatePackage>
<EndMarketingDatePackage>20200930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0208-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0208-10) </PackageDescription>
<NDC11Code>00378-0208-10</NDC11Code>
<ProductNDC>0378-0208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810827</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19810827</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0378-0213-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0378-0213-10) </PackageDescription>
<NDC11Code>00378-0213-10</NDC11Code>
<ProductNDC>0378-0213</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086831</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1-hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake.</Description>
</NDC>
</NDCList>