{
"NDC": [
{
"NDCCode": "50228-340-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-340-90) ",
"NDC11Code": "50228-0340-90",
"ProductNDC": "50228-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208130",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180629",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "50228-340-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-340-10) ",
"NDC11Code": "50228-0340-10",
"ProductNDC": "50228-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208130",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180629",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "50228-340-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50228-340-30) ",
"NDC11Code": "50228-0340-30",
"ProductNDC": "50228-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208130",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180629",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification."
},
{
"NDCCode": "29300-340-19",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (29300-340-19) > 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "29300-0340-19",
"ProductNDC": "29300-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078680",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100723",
"SamplePackage": "N"
},
{
"NDCCode": "33342-340-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-340-10) ",
"NDC11Code": "33342-0340-10",
"ProductNDC": "33342-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210248",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241113",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets is indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (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 determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].",
"Description": "Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of 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 C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya), xanthan gum."
},
{
"NDCCode": "42254-340-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42254-340-90)",
"NDC11Code": "42254-0340-90",
"ProductNDC": "42254-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090118",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.",
"Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α- Epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½ H2O M.W.494.49. Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W.151.16. Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 7.5 mg/325 mg and 10 mg/650 mg tablets also include D&C Yellow #10 aluminum lake. The 10 mg/500 mg and 10 mg/650 mg tablets also include FD&C Blue #2 aluminum lake. 5 mg/325 mg, 7.5 mg/325 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/325 mg, 10 mg/500 mg, 10 mg/650 mg, and 10 mg/660 mg; Meets USP Dissolution Test 1. 5 mg/500 mg and 7.5 mg/750 mg; Meets USP Dissolution Test 2."
},
{
"NDCCode": "42291-340-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-340-90)",
"NDC11Code": "42291-0340-90",
"ProductNDC": "42291-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077369",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE; IRBESARTAN",
"StrengthNumber": "12.5; 150",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-02-06"
},
{
"NDCCode": "43353-340-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-340-60)",
"NDC11Code": "43353-0340-60",
"ProductNDC": "43353-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075985",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet intended for oral administration contains 500 mg, 850 mg or 1000 mg metformin hydrochloride. In addition, each metformin hydrochloride tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "52301-340-90",
"PackageDescription": "90 [hp_X] in 1 BOTTLE, PLASTIC (52301-340-90) ",
"NDC11Code": "52301-0340-90",
"ProductNDC": "52301-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phytofed",
"ProprietaryNameSuffix": "Hf",
"NonProprietaryName": "Euphrasia Officinalis, Urtica Dioica, Hydrastis Canadensis, Vitis Vinifera, Echinacea Purpurea",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021010",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dee Cee Laboratories",
"SubstanceName": "EUPHRASIA STRICTA; URTICA DIOICA LEAF; HYDRASTIS CANADENSIS WHOLE; VITIS VINIFERA SEED; ECHINACEA PURPUREA ROOT",
"StrengthNumber": "1; 1; 1; 1; 1",
"StrengthUnit": "[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]",
"Status": "Deprecated",
"LastUpdate": "2020-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20021010",
"SamplePackage": "N"
},
{
"NDCCode": "54348-340-90",
"PackageDescription": "1 BOTTLE in 1 BOX (54348-340-90) > 90 TABLET in 1 BOTTLE",
"NDC11Code": "54348-0340-90",
"ProductNDC": "54348-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091426",
"LabelerName": "PharmPak, Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190709",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy 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 ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow #6."
},
{
"NDCCode": "55700-340-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (55700-340-90) ",
"NDC11Code": "55700-0340-90",
"ProductNDC": "55700-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151207",
"SamplePackage": "N"
},
{
"NDCCode": "60760-340-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (60760-340-90) ",
"NDC11Code": "60760-0340-90",
"ProductNDC": "60760-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130516",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130516",
"SamplePackage": "N"
},
{
"NDCCode": "61786-340-19",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61786-340-19)",
"NDC11Code": "61786-0340-19",
"ProductNDC": "61786-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150616",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090060",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-09-01"
},
{
"NDCCode": "63187-340-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) ",
"NDC11Code": "63187-0340-90",
"ProductNDC": "63187-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230221",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "64543-340-90",
"PackageDescription": "90 TABLET, MULTILAYER in 1 BOTTLE (64543-340-90)",
"NDC11Code": "64543-0340-90",
"ProductNDC": "64543-340",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Liquibid Pd-r",
"NonProprietaryName": "Guaifenesin And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Capellon Pharmaceuticals, LLC",
"SubstanceName": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "200; 5",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-03-12"
},
{
"NDCCode": "68387-340-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (68387-340-90)",
"NDC11Code": "68387-0340-90",
"ProductNDC": "68387-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Keltman Pharmaceuticals Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methocarbamol Tablets 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 Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate."
},
{
"NDCCode": "70934-340-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-340-90) ",
"NDC11Code": "70934-0340-90",
"ProductNDC": "70934-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190408",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019123",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190530",
"SamplePackage": "N"
},
{
"NDCCode": "71205-340-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-340-90) ",
"NDC11Code": "71205-0340-90",
"ProductNDC": "71205-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087022",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "72603-340-01",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72603-340-01) ",
"NDC11Code": "72603-0340-01",
"ProductNDC": "72603-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "76420-340-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (76420-340-90) ",
"NDC11Code": "76420-0340-90",
"ProductNDC": "76420-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250502",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "50228-116-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-116-90) ",
"NDC11Code": "50228-0116-90",
"ProductNDC": "50228-116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206381",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide."
},
{
"NDCCode": "50228-117-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-117-90) ",
"NDC11Code": "50228-0117-90",
"ProductNDC": "50228-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206381",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide."
},
{
"NDCCode": "50228-118-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-118-90) ",
"NDC11Code": "50228-0118-90",
"ProductNDC": "50228-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206381",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide."
},
{
"NDCCode": "50228-119-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90) ",
"NDC11Code": "50228-0119-90",
"ProductNDC": "50228-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206381",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide."
},
{
"NDCCode": "50228-121-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-121-90) ",
"NDC11Code": "50228-0121-90",
"ProductNDC": "50228-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204165",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"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": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y 12platelet inhibitor indicated for: : 1 Acute coronary syndrome For patients with non–ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1) , 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2) .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "50228-124-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90) ",
"NDC11Code": "50228-0124-90",
"ProductNDC": "50228-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204165",
"LabelerName": "ScieGen Pharmaceuticals 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": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y 12platelet inhibitor indicated for: : 1 Acute coronary syndrome For patients with non–ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1) , 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2) .",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide and yellow iron oxide."
},
{
"NDCCode": "50228-126-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50228-126-90) ",
"NDC11Code": "50228-0126-90",
"ProductNDC": "50228-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203855",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141029",
"SamplePackage": "N",
"IndicationAndUsage": "PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "50228-127-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50228-127-90) ",
"NDC11Code": "50228-0127-90",
"ProductNDC": "50228-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203855",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141029",
"SamplePackage": "N",
"IndicationAndUsage": "PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "50228-128-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50228-128-90) ",
"NDC11Code": "50228-0128-90",
"ProductNDC": "50228-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203855",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141029",
"SamplePackage": "N",
"IndicationAndUsage": "PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "50228-129-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (50228-129-90) ",
"NDC11Code": "50228-0129-90",
"ProductNDC": "50228-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203855",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141029",
"SamplePackage": "N",
"IndicationAndUsage": "PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>50228-340-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-340-90) </PackageDescription>
<NDC11Code>50228-0340-90</NDC11Code>
<ProductNDC>50228-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208130</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>50228-340-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (50228-340-10) </PackageDescription>
<NDC11Code>50228-0340-10</NDC11Code>
<ProductNDC>50228-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208130</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>50228-340-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50228-340-30) </PackageDescription>
<NDC11Code>50228-0340-30</NDC11Code>
<ProductNDC>50228-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208130</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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. 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. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4(1-hydroxy-1-methylethyl)-2-propyl-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29H 30N 6O 6 and its structural formula is:. Olmesartan medoxomil is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and slightly soluble in methanol. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, silicified microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification.</Description>
</NDC>
<NDC>
<NDCCode>29300-340-19</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (29300-340-19) > 90 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>29300-0340-19</NDC11Code>
<ProductNDC>29300-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078680</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33342-340-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-340-10) </PackageDescription>
<NDC11Code>33342-0340-10</NDC11Code>
<ProductNDC>33342-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210248</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets is indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (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 determined [see Warnings and Precautions (5.7)]. Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of 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 C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82oC. Fenofibrate USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910, sodium lauryl sulfate, lecithin, sucrose, lactose monohydrate, silicified microcrystalline cellulose, crospovidone type-A, colloidal silicon dioxide and sodium stearyl fumarate. In addition, individual tablets contain:. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, iron oxide yellow, lecithin (soya), xanthan gum. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, lecithin (soya), xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>42254-340-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42254-340-90)</PackageDescription>
<NDC11Code>42254-0340-90</NDC11Code>
<ProductNDC>42254-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090118</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
<Description>Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α- Epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. C18H21NO3C4H6O62½ H2O M.W.494.49. Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2 M.W.151.16. Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in the following strengths. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 7.5 mg/325 mg and 10 mg/650 mg tablets also include D&C Yellow #10 aluminum lake. The 10 mg/500 mg and 10 mg/650 mg tablets also include FD&C Blue #2 aluminum lake. 5 mg/325 mg, 7.5 mg/325 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/325 mg, 10 mg/500 mg, 10 mg/650 mg, and 10 mg/660 mg; Meets USP Dissolution Test 1. 5 mg/500 mg and 7.5 mg/750 mg; Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>42291-340-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-340-90)</PackageDescription>
<NDC11Code>42291-0340-90</NDC11Code>
<ProductNDC>42291-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077369</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; IRBESARTAN</SubstanceName>
<StrengthNumber>12.5; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-02-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-340-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-340-60)</PackageDescription>
<NDC11Code>43353-0340-60</NDC11Code>
<ProductNDC>43353-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075985</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Each metformin hydrochloride tablet intended for oral administration contains 500 mg, 850 mg or 1000 mg metformin hydrochloride. In addition, each metformin hydrochloride tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52301-340-90</NDCCode>
<PackageDescription>90 [hp_X] in 1 BOTTLE, PLASTIC (52301-340-90) </PackageDescription>
<NDC11Code>52301-0340-90</NDC11Code>
<ProductNDC>52301-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phytofed</ProprietaryName>
<ProprietaryNameSuffix>Hf</ProprietaryNameSuffix>
<NonProprietaryName>Euphrasia Officinalis, Urtica Dioica, Hydrastis Canadensis, Vitis Vinifera, Echinacea Purpurea</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021010</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dee Cee Laboratories</LabelerName>
<SubstanceName>EUPHRASIA STRICTA; URTICA DIOICA LEAF; HYDRASTIS CANADENSIS WHOLE; VITIS VINIFERA SEED; ECHINACEA PURPUREA ROOT</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54348-340-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (54348-340-90) > 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>54348-0340-90</NDC11Code>
<ProductNDC>54348-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091426</ApplicationNumber>
<LabelerName>PharmPak, Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are an aldosterone antagonist indicated for: 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). , 2 Use as an add-on therapy 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 ( 1.2). , 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3). , 4 Treatment of primary hyperaldosternism for: ( 1.4) .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:. Spironolactone, USP is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin. The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>55700-340-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55700-340-90) </PackageDescription>
<NDC11Code>55700-0340-90</NDC11Code>
<ProductNDC>55700-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-340-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (60760-340-90) </PackageDescription>
<NDC11Code>60760-0340-90</NDC11Code>
<ProductNDC>60760-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130516</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>St Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61786-340-19</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61786-340-19)</PackageDescription>
<NDC11Code>61786-0340-19</NDC11Code>
<ProductNDC>61786-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150616</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090060</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>63187-340-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) </PackageDescription>
<NDC11Code>63187-0340-90</NDC11Code>
<ProductNDC>63187-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:. As oral formulation for the. · Treatment of schizophrenia. (1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2). · Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine is a yellow crystalline solid, which is practically insoluble in water Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>64543-340-90</NDCCode>
<PackageDescription>90 TABLET, MULTILAYER in 1 BOTTLE (64543-340-90)</PackageDescription>
<NDC11Code>64543-0340-90</NDC11Code>
<ProductNDC>64543-340</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Liquibid Pd-r</ProprietaryName>
<NonProprietaryName>Guaifenesin And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Capellon Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-03-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>68387-340-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (68387-340-90)</PackageDescription>
<NDC11Code>68387-0340-90</NDC11Code>
<ProductNDC>68387-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085159</ApplicationNumber>
<LabelerName>Keltman Pharmaceuticals 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>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol Tablets 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 Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is. The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70934-340-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-340-90) </PackageDescription>
<NDC11Code>70934-0340-90</NDC11Code>
<ProductNDC>70934-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190408</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019123</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-340-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-340-90) </PackageDescription>
<NDC11Code>71205-0340-90</NDC11Code>
<ProductNDC>71205-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087022</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>72603-340-01</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72603-340-01) </PackageDescription>
<NDC11Code>72603-0340-01</NDC11Code>
<ProductNDC>72603-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>76420-340-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (76420-340-90) </PackageDescription>
<NDC11Code>76420-0340-90</NDC11Code>
<ProductNDC>76420-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21H 31N 3O 52H 2O and its structural formula is:. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch *, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>50228-116-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-116-90) </PackageDescription>
<NDC11Code>50228-0116-90</NDC11Code>
<ProductNDC>50228-116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206381</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-117-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-117-90) </PackageDescription>
<NDC11Code>50228-0117-90</NDC11Code>
<ProductNDC>50228-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206381</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-118-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-118-90) </PackageDescription>
<NDC11Code>50228-0118-90</NDC11Code>
<ProductNDC>50228-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206381</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-119-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90) </PackageDescription>
<NDC11Code>50228-0119-90</NDC11Code>
<ProductNDC>50228-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206381</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events., 2 As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C):in adults with hypercholesterolemia.and slow the progression of atherosclerosis in adults.in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium, USP is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1001.14. Rosuvastatin calcium, USP is a white to almost white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 1.4 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium, USP) and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, red ferric oxide, triacetin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-121-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-121-90) </PackageDescription>
<NDC11Code>50228-0121-90</NDC11Code>
<ProductNDC>50228-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204165</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</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>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y 12platelet inhibitor indicated for: : 1 Acute coronary syndrome For patients with non–ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1) , 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2) .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-124-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50228-124-90) </PackageDescription>
<NDC11Code>50228-0124-90</NDC11Code>
<ProductNDC>50228-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204165</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals 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>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y 12platelet inhibitor indicated for: : 1 Acute coronary syndrome For patients with non–ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1) For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1) , 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2) .</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y 12ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>50228-126-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50228-126-90) </PackageDescription>
<NDC11Code>50228-0126-90</NDC11Code>
<ProductNDC>50228-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203855</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50228-127-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50228-127-90) </PackageDescription>
<NDC11Code>50228-0127-90</NDC11Code>
<ProductNDC>50228-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203855</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50228-128-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50228-128-90) </PackageDescription>
<NDC11Code>50228-0128-90</NDC11Code>
<ProductNDC>50228-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203855</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50228-129-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50228-129-90) </PackageDescription>
<NDC11Code>50228-0129-90</NDC11Code>
<ProductNDC>50228-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203855</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRAMIPEXOLE DIHYDROCHLORIDE tablets are a non-ergot dopamine agonist indicated for the treatment of: 1 Parkinson’s disease (PD) ( 1.1) , 2 Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2) .</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2O, and its molecular weight is 302.27. The structural formula is:. Pramipexole dihydrochloride is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole Dihydrochloride is freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride. Pramipexole dihydrochloride tablets 0.125 mg:Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg:Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg:Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.75 mg:Each tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg:Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg:Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
</NDCList>