{
"NDC": [
{
"NDCCode": "62135-894-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-894-90) ",
"NDC11Code": "62135-0894-90",
"ProductNDC": "62135-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211407",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240912",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia 2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGSand PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. C = cholesterol TG = triglycerides. LDL = low density lipoprotein. VLDL = very low density lipoprotein. IDL = intermediate density lipoprotein. The NCEP Treatment Guidelines. a Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). b Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 4 5 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL- C <35 mg/dL (<0.91mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is ≥ 60 mg/dL (≥1.6 mmol/L). c In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment.",
"Description": "Fenofibrate USP, (micronized) is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1- methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients:The inactive ingredients in fenofibrate capsules include lactose monohydrate, crospovidone, pregelatinized starch, povidone, sodium lauryl sulfate and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C Blue # 1, and FD#C Red #3. Additionally, the capsule imprint ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonium solution, black iron oxide, potassium hydroxide and purified water."
},
{
"NDCCode": "31722-894-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90) ",
"NDC11Code": "31722-0894-90",
"ProductNDC": "31722-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
"NonProprietaryName": "Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209242",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "40; 5; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251006",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.",
"Description": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its empirical formula is C 26H 31CIN 2O 8S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulphonamide 1,1- dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white or almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odourless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Amlodipine besylate USP is slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Hydrochlorothiazide USP is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains iron oxide black, iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "35356-894-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (35356-894-90)",
"NDC11Code": "35356-0894-90",
"ProductNDC": "35356-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42291-894-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-894-90) ",
"NDC11Code": "42291-0894-90",
"ProductNDC": "42291-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079098",
"LabelerName": "AvKARE",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120511",
"SamplePackage": "N"
},
{
"NDCCode": "43063-894-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-894-90) ",
"NDC11Code": "43063-0894-90",
"ProductNDC": "43063-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone Hydrochloride",
"NonProprietaryName": "Pioglitazone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200044",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180912",
"SamplePackage": "N"
},
{
"NDCCode": "47335-894-19",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (47335-894-19) ",
"NDC11Code": "47335-0894-19",
"ProductNDC": "47335-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090494",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120518",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "47335-894-81",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (47335-894-81) ",
"NDC11Code": "47335-0894-81",
"ProductNDC": "47335-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090494",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120518",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide."
},
{
"NDCCode": "47918-894-63",
"PackageDescription": "90 PACKAGE in 1 CARTON (47918-894-63) > 1 KIT in 1 PACKAGE * 60 POWDER, METERED in 1 BLISTER PACK * 30 POWDER, METERED in 1 BLISTER PACK",
"NDC11Code": "47918-0894-63",
"ProductNDC": "47918-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Afrezza",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "KIT",
"StartMarketingDate": "20140711",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022472",
"LabelerName": "Mannkind Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140711",
"SamplePackage": "N"
},
{
"NDCCode": "49349-894-19",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 CANISTER (49349-894-19)",
"NDC11Code": "49349-0894-19",
"ProductNDC": "49349-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077285",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "51991-894-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (51991-894-90) ",
"NDC11Code": "51991-0894-90",
"ProductNDC": "51991-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209818",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N"
},
{
"NDCCode": "55700-894-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55700-894-90) ",
"NDC11Code": "55700-0894-90",
"ProductNDC": "55700-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210305",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "70934-894-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70934-894-90) ",
"NDC11Code": "70934-0894-90",
"ProductNDC": "70934-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "N"
},
{
"NDCCode": "71205-894-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-894-90) ",
"NDC11Code": "71205-0894-90",
"ProductNDC": "71205-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040733",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210802",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
"Description": "Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2\",2\"'-[(4,8- Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole Tablets, USP for oral administration contain. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: corn starch, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "71610-894-60",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71610-894-60) ",
"NDC11Code": "71610-0894-60",
"ProductNDC": "71610-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "76420-894-90",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (76420-894-90) ",
"NDC11Code": "76420-0894-90",
"ProductNDC": "76420-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250128",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "62135-041-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-041-90) ",
"NDC11Code": "62135-0041-90",
"ProductNDC": "62135-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-042-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-042-90) ",
"NDC11Code": "62135-0042-90",
"ProductNDC": "62135-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-043-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-043-90) ",
"NDC11Code": "62135-0043-90",
"ProductNDC": "62135-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076483",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate."
},
{
"NDCCode": "62135-051-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-051-90) ",
"NDC11Code": "62135-0051-90",
"ProductNDC": "62135-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-052-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-052-90) ",
"NDC11Code": "62135-0052-90",
"ProductNDC": "62135-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-053-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-053-90) ",
"NDC11Code": "62135-0053-90",
"ProductNDC": "62135-053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-054-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-054-90) ",
"NDC11Code": "62135-0054-90",
"ProductNDC": "62135-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin Mesylate",
"NonProprietaryName": "Doxazosin Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20001018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075646",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "62135-067-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-067-90) ",
"NDC11Code": "62135-0067-90",
"ProductNDC": "62135-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19840806",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018829",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4."
},
{
"NDCCode": "62135-068-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-068-90) ",
"NDC11Code": "62135-0068-90",
"ProductNDC": "62135-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19860305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070651",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1."
},
{
"NDCCode": "62135-205-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-205-90) ",
"NDC11Code": "62135-0205-90",
"ProductNDC": "62135-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-206-90) ",
"NDC11Code": "62135-0206-90",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-210-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-210-90) ",
"NDC11Code": "62135-0210-90",
"ProductNDC": "62135-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090035",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220303",
"SamplePackage": "N",
"IndicationAndUsage": "Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid."
},
{
"NDCCode": "62135-236-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-236-90) ",
"NDC11Code": "62135-0236-90",
"ProductNDC": "62135-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088212",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "DESCRIPTION: Cyproheptadine HCl, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a while to slightly yellowish, crystalline, solid. with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo (a, d) cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21H 21NHC1. and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride is available in 4 mg tablets. Each tablet contains. Active Ingredient. Cyproheptad1ne Hydrochloride ...................... 4 mg. Each tablet contains. Inactive Ingredients:. Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), stearic acid."
},
{
"NDCCode": "62135-242-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90) ",
"NDC11Code": "62135-0242-90",
"ProductNDC": "62135-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naltrexone Hydrochloride",
"NonProprietaryName": "Naltrexone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207905",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "NALTREXONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220105",
"SamplePackage": "N",
"IndicationAndUsage": "Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.",
"Description": "Naltrexone hydrochloride tablets, USP an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride, USP is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride. Naltrexone hydrochloride is a white or almost white powder. The hydrochloride salt is freely soluble in water. Naltrexone hydrochloride tablets, USP are available as film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone hydrochloride tablets, USP also contain: lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, hydroxypropyl cellulose, yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "62135-271-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (62135-271-90) ",
"NDC11Code": "62135-0271-90",
"ProductNDC": "62135-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078745",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260102",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
}
]
}
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<NDC>
<NDCCode>62135-894-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-894-90) </PackageDescription>
<NDC11Code>62135-0894-90</NDC11Code>
<ProductNDC>62135-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211407</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>134</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia 2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGSand PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. C = cholesterol TG = triglycerides. LDL = low density lipoprotein. VLDL = very low density lipoprotein. IDL = intermediate density lipoprotein. The NCEP Treatment Guidelines. a Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). b Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 4 5 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL- C <35 mg/dL (<0.91mmol/L); and diabetes mellitus. Subtract 1 risk factor if HDL-C is ≥ 60 mg/dL (≥1.6 mmol/L). c In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment.</IndicationAndUsage>
<Description>Fenofibrate USP, (micronized) is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1- methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients:The inactive ingredients in fenofibrate capsules include lactose monohydrate, crospovidone, pregelatinized starch, povidone, sodium lauryl sulfate and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C Blue # 1, and FD#C Red #3. Additionally, the capsule imprint ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonium solution, black iron oxide, potassium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>31722-894-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90) </PackageDescription>
<NDC11Code>31722-0894-90</NDC11Code>
<ProductNDC>31722-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209242</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>40; 5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20251006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
<Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 3,5-pyridine dicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl 5-methyl ester, (±)-monobenzene sulfonate. Its empirical formula is C 26H 31CIN 2O 8S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulphonamide 1,1- dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white or almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odourless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Amlodipine besylate USP is slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Hydrochlorothiazide USP is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains iron oxide black, iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide. The botanical source for pregelatinized starch is corn starch.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-894-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-894-90) </PackageDescription>
<NDC11Code>42291-0894-90</NDC11Code>
<ProductNDC>42291-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079098</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-894-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43063-894-90) </PackageDescription>
<NDC11Code>43063-0894-90</NDC11Code>
<ProductNDC>43063-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200044</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47335-894-19</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (47335-894-19) </PackageDescription>
<NDC11Code>47335-0894-19</NDC11Code>
<ProductNDC>47335-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090494</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-894-81</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (47335-894-81) </PackageDescription>
<NDC11Code>47335-0894-81</NDC11Code>
<ProductNDC>47335-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090494</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for: : 1 Acute coronary syndrome .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as pink, round, biconvex, imprinted, film-coated tablets containing 97.875 mg of clopidogrel bisulfate, USP which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains mannitol, microcrystalline cellulose, low substituted hydroxypropylcellulose, polyethylene glycol and hydrogenated castor oil as inactive ingredients. The pink film coating contains hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Imprinting ink contains shellac glaze, black iron oxide, N-butyl alcohol, propylene glycol, ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>47918-894-63</NDCCode>
<PackageDescription>90 PACKAGE in 1 CARTON (47918-894-63) > 1 KIT in 1 PACKAGE * 60 POWDER, METERED in 1 BLISTER PACK * 30 POWDER, METERED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47918-0894-63</NDC11Code>
<ProductNDC>47918-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Afrezza</ProprietaryName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140711</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022472</ApplicationNumber>
<LabelerName>Mannkind Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49349-894-19</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 CANISTER (49349-894-19)</PackageDescription>
<NDC11Code>49349-0894-19</NDC11Code>
<ProductNDC>49349-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077285</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>51991-894-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (51991-894-90) </PackageDescription>
<NDC11Code>51991-0894-90</NDC11Code>
<ProductNDC>51991-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209818</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55700-894-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55700-894-90) </PackageDescription>
<NDC11Code>55700-0894-90</NDC11Code>
<ProductNDC>55700-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>70934-894-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70934-894-90) </PackageDescription>
<NDC11Code>70934-0894-90</NDC11Code>
<ProductNDC>70934-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-894-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-894-90) </PackageDescription>
<NDC11Code>71205-0894-90</NDC11Code>
<ProductNDC>71205-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040733</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
<Description>Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2",2"'-[(4,8- Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole Tablets, USP for oral administration contain. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: corn starch, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-894-60</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71610-894-60) </PackageDescription>
<NDC11Code>71610-0894-60</NDC11Code>
<ProductNDC>71610-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208677</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-894-90</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (76420-894-90) </PackageDescription>
<NDC11Code>76420-0894-90</NDC11Code>
<ProductNDC>76420-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-041-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-041-90) </PackageDescription>
<NDC11Code>62135-0041-90</NDC11Code>
<ProductNDC>62135-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-042-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-042-90) </PackageDescription>
<NDC11Code>62135-0042-90</NDC11Code>
<ProductNDC>62135-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-043-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-043-90) </PackageDescription>
<NDC11Code>62135-0043-90</NDC11Code>
<ProductNDC>62135-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076483</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION) . In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS). In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Anaphylactoid and Possible Related Reactions, Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl- 1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Empirical formula: C 30H 45NNa0 7P Molecular weight: 585.65. Fosinopril Sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: carnauba wax, crospovidone, lactose anhydrous, microcrystalline cellulose, and zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-051-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-051-90) </PackageDescription>
<NDC11Code>62135-0051-90</NDC11Code>
<ProductNDC>62135-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-052-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-052-90) </PackageDescription>
<NDC11Code>62135-0052-90</NDC11Code>
<ProductNDC>62135-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-053-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-053-90) </PackageDescription>
<NDC11Code>62135-0053-90</NDC11Code>
<ProductNDC>62135-053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-054-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-054-90) </PackageDescription>
<NDC11Code>62135-0054-90</NDC11Code>
<ProductNDC>62135-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin Mesylate</ProprietaryName>
<NonProprietaryName>Doxazosin Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075646</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin mesylate tablets are an alpha 1 adrenergic antagonist indicated for: ( 1) : 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23H 25N 5O 5 · CH 4O 3S and the molecular weight is 547.6. It has the following structure:. Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, and 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>62135-067-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-067-90) </PackageDescription>
<NDC11Code>62135-0067-90</NDC11Code>
<ProductNDC>62135-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840806</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018829</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of indomethacin capsules, USP and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see Warnings: Gastrointestinal Bleeding, Ulceration, and Perforation). Indomethacin has been found effective in active stages of the following. 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). 5. Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The structural formula is. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19H 16C 1NO 4.</Description>
</NDC>
<NDC>
<NDCCode>62135-068-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-068-90) </PackageDescription>
<NDC11Code>62135-0068-90</NDC11Code>
<ProductNDC>62135-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070651</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin Capsules is indicated for. : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19H 16C lNO 4, and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>62135-205-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-205-90) </PackageDescription>
<NDC11Code>62135-0205-90</NDC11Code>
<ProductNDC>62135-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-206-90) </PackageDescription>
<NDC11Code>62135-0206-90</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-210-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-210-90) </PackageDescription>
<NDC11Code>62135-0210-90</NDC11Code>
<ProductNDC>62135-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090035</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino] benzoyl]L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-236-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-236-90) </PackageDescription>
<NDC11Code>62135-0236-90</NDC11Code>
<ProductNDC>62135-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088212</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: Perennial and seasonal allergic rhinitis, Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>DESCRIPTION: Cyproheptadine HCl, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a while to slightly yellowish, crystalline, solid. with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo (a, d) cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21H 21NHC1. and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride is available in 4 mg tablets. Each tablet contains. Active Ingredient. Cyproheptad1ne Hydrochloride ...................... 4 mg. Each tablet contains. Inactive Ingredients:. Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>62135-242-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-242-90) </PackageDescription>
<NDC11Code>62135-0242-90</NDC11Code>
<ProductNDC>62135-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naltrexone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naltrexone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207905</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>NALTREXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naltrexone hydrochloride tablets are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.</IndicationAndUsage>
<Description>Naltrexone hydrochloride tablets, USP an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride, USP is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride. Naltrexone hydrochloride is a white or almost white powder. The hydrochloride salt is freely soluble in water. Naltrexone hydrochloride tablets, USP are available as film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone hydrochloride tablets, USP also contain: lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, hydroxypropyl cellulose, yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-271-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (62135-271-90) </PackageDescription>
<NDC11Code>62135-0271-90</NDC11Code>
<ProductNDC>62135-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078745</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2 S, 3a S, 6a S)-1 [( S)- N-[( S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [ b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with black ink containing shellac, black iron oxide, n-butyl alcohol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. The structural formula for ramipril is. Its molecular formula is C 23H 32N 2O 5and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
</NDCList>