{
"NDC": [
{
"NDCCode": "35561-356-12",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-356-12) ",
"NDC11Code": "35561-0356-12",
"ProductNDC": "35561-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215591",
"LabelerName": "Bostal LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220331",
"SamplePackage": "N",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "35561-356-13",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-356-13) ",
"NDC11Code": "35561-0356-13",
"ProductNDC": "35561-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215591",
"LabelerName": "Bostal LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250409",
"SamplePackage": "N",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "35561-356-99",
"PackageDescription": "63429 TABLET, EXTENDED RELEASE in 1 DRUM (35561-356-99) ",
"NDC11Code": "35561-0356-99",
"ProductNDC": "35561-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215591",
"LabelerName": "Bostal LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250427",
"SamplePackage": "N",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "35561-211-12",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-12) ",
"NDC11Code": "35561-0211-12",
"ProductNDC": "35561-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200958",
"LabelerName": "Bostal LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181009",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg."
},
{
"NDCCode": "35561-212-12",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-212-12) ",
"NDC11Code": "35561-0212-12",
"ProductNDC": "35561-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200958",
"LabelerName": "Bostal LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181010",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg."
},
{
"NDCCode": "35561-345-12",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35561-345-12) ",
"NDC11Code": "35561-0345-12",
"ProductNDC": "35561-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "67",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "35561-346-12",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35561-346-12) ",
"NDC11Code": "35561-0346-12",
"ProductNDC": "35561-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "35561-347-12",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (35561-347-12) ",
"NDC11Code": "35561-0347-12",
"ProductNDC": "35561-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207805",
"LabelerName": "Bostal LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
"Description": "Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "35561-349-12",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-12) ",
"NDC11Code": "35561-0349-12",
"ProductNDC": "35561-349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200958",
"LabelerName": "Bostal LLC",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220716",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg."
},
{
"NDCCode": "35561-355-12",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12) ",
"NDC11Code": "35561-0355-12",
"ProductNDC": "35561-355",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215591",
"LabelerName": "Bostal LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220331",
"SamplePackage": "N",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "35561-357-12",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-12) ",
"NDC11Code": "35561-0357-12",
"ProductNDC": "35561-357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine Er",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215591",
"LabelerName": "Bostal LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220331",
"SamplePackage": "N",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43063-356-12",
"PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (43063-356-12)",
"NDC11Code": "43063-0356-12",
"ProductNDC": "43063-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040157",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "750; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-08-29"
},
{
"NDCCode": "55910-356-12",
"PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (55910-356-12)",
"NDC11Code": "55910-0356-12",
"ProductNDC": "55910-356",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antacid Supreme Cherry",
"NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Dollar General",
"SubstanceName": "ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE",
"StrengthNumber": "400; 135",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63621-356-25",
"PackageDescription": "12 BOTTLE, PUMP in 1 BOX (63621-356-25) / 236.6 mL in 1 BOTTLE, PUMP",
"NDC11Code": "63621-0356-25",
"ProductNDC": "63621-356",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sundrops 75",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091014",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Sunburst Chemicals, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".6",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091014",
"SamplePackage": "N",
"IndicationAndUsage": "To help reduce amount of bacteria on the skin."
},
{
"NDCCode": "67544-356-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-12) ",
"NDC11Code": "67544-0356-12",
"ProductNDC": "67544-356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viagra",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980327",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020895",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20050304",
"SamplePackage": "N",
"IndicationAndUsage": "VIAGRA is indicated for the treatment of erectile dysfunction.",
"Description": "VIAGRA (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake."
},
{
"NDCCode": "68428-356-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-356-12) ",
"NDC11Code": "68428-0356-12",
"ProductNDC": "68428-356",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daphne Indica",
"NonProprietaryName": "Daphne Odora Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "DAPHNE ODORA BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "84126-356-12",
"PackageDescription": "354 mL in 1 BOTTLE, PLASTIC (84126-356-12) ",
"NDC11Code": "84126-0356-12",
"ProductNDC": "84126-356",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Dayquil",
"ProprietaryNameSuffix": "Intense Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "1000; 30",
"StrengthUnit": "mg/30mL; mg/30mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever."
},
{
"NDCCode": "84126-358-24",
"PackageDescription": "1 KIT in 1 PACKAGE (84126-358-24) * 354 mL in 1 BOTTLE, PLASTIC (84126-356-12) * 354 mL in 1 BOTTLE, PLASTIC (84126-357-12) ",
"NDC11Code": "84126-0358-24",
"ProductNDC": "84126-358",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Dayquil And Vicks Nyquil",
"ProprietaryNameSuffix": "Intense Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N"
},
{
"NDCCode": "84289-356-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (84289-356-12) ",
"NDC11Code": "84289-0356-12",
"ProductNDC": "84289-356",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 81mg Adult Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "PHARMAMED USA INC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241001",
"SamplePackage": "Y",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product."
},
{
"NDCCode": "35561-254-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-10) ",
"NDC11Code": "35561-0254-10",
"ProductNDC": "35561-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-254-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-13) ",
"NDC11Code": "35561-0254-13",
"ProductNDC": "35561-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-255-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-10) ",
"NDC11Code": "35561-0255-10",
"ProductNDC": "35561-255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-255-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-13) ",
"NDC11Code": "35561-0255-13",
"ProductNDC": "35561-255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-256-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-10) ",
"NDC11Code": "35561-0256-10",
"ProductNDC": "35561-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-256-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-13) ",
"NDC11Code": "35561-0256-13",
"ProductNDC": "35561-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-257-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-10) ",
"NDC11Code": "35561-0257-10",
"ProductNDC": "35561-257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "35561-257-13",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-13) ",
"NDC11Code": "35561-0257-13",
"ProductNDC": "35561-257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "N/a",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208824",
"LabelerName": "Bostal LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191129",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red."
},
{
"NDCCode": "0264-3183-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3183-11",
"ProductNDC": "0264-3183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem And Sodium Chloride",
"NonProprietaryName": "Meropenem And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202106",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP)."
},
{
"NDCCode": "0264-3185-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3185-11",
"ProductNDC": "0264-3185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meropenem And Sodium Chloride",
"NonProprietaryName": "Meropenem And Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202106",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "MEROPENEM",
"StrengthNumber": "1",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Carbapenems [CS], Penem Antibacterial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150430",
"SamplePackage": "N",
"IndicationAndUsage": "Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .",
"Description": "Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP)."
},
{
"NDCCode": "0904-6706-06",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (0904-6706-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00904-6706-06",
"ProductNDC": "0904-6706",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omega-3-acid Ethyl Esters",
"NonProprietaryName": "Omega-3-acid Ethyl Esters",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090973",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140930",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.",
"Description": "Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The molecular formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The molecular formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide."
}
]
}
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<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-356-12) </PackageDescription>
<NDC11Code>35561-0356-12</NDC11Code>
<ProductNDC>35561-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine Er</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
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<ApplicationNumber>ANDA215591</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3.</Description>
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<NDC>
<NDCCode>35561-356-13</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-356-13) </PackageDescription>
<NDC11Code>35561-0356-13</NDC11Code>
<ProductNDC>35561-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine Er</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
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<StartMarketingDatePackage>20250409</StartMarketingDatePackage>
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<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3.</Description>
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<NDCCode>35561-356-99</NDCCode>
<PackageDescription>63429 TABLET, EXTENDED RELEASE in 1 DRUM (35561-356-99) </PackageDescription>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215591</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
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<LastUpdate>2026-04-30</LastUpdate>
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<StartMarketingDatePackage>20250427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>35561-211-12</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-12) </PackageDescription>
<NDC11Code>35561-0211-12</NDC11Code>
<ProductNDC>35561-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200958</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg.</Description>
</NDC>
<NDC>
<NDCCode>35561-212-12</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-212-12) </PackageDescription>
<NDC11Code>35561-0212-12</NDC11Code>
<ProductNDC>35561-212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200958</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg.</Description>
</NDC>
<NDC>
<NDCCode>35561-345-12</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35561-345-12) </PackageDescription>
<NDC11Code>35561-0345-12</NDC11Code>
<ProductNDC>35561-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>67</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>35561-346-12</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35561-346-12) </PackageDescription>
<NDC11Code>35561-0346-12</NDC11Code>
<ProductNDC>35561-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>134</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>35561-347-12</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (35561-347-12) </PackageDescription>
<NDC11Code>35561-0347-12</NDC11Code>
<ProductNDC>35561-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207805</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
<Description>Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4- chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: sodium lauryl sulfate, croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide, FD&C Yellow 6, D&C Yellow 10 and gelatin. The capsule shell imprinting ink contains the following inactive ingredients: shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>35561-349-12</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-12) </PackageDescription>
<NDC11Code>35561-0349-12</NDC11Code>
<ProductNDC>35561-349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200958</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol is 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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg.</Description>
</NDC>
<NDC>
<NDCCode>35561-355-12</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12) </PackageDescription>
<NDC11Code>35561-0355-12</NDC11Code>
<ProductNDC>35561-355</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine Er</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215591</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>35561-357-12</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-12) </PackageDescription>
<NDC11Code>35561-0357-12</NDC11Code>
<ProductNDC>35561-357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine Er</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215591</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H-dibenz[ b, f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: cellulose compounds, dextrates, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, talc, iron oxide yellow. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>43063-356-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (43063-356-12)</PackageDescription>
<NDC11Code>43063-0356-12</NDC11Code>
<ProductNDC>43063-356</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>19960412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040157</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>750; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>55910-356-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE, PLASTIC (55910-356-12)</PackageDescription>
<NDC11Code>55910-0356-12</NDC11Code>
<ProductNDC>55910-356</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antacid Supreme Cherry</ProprietaryName>
<NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Dollar General</LabelerName>
<SubstanceName>ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>400; 135</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63621-356-25</NDCCode>
<PackageDescription>12 BOTTLE, PUMP in 1 BOX (63621-356-25) / 236.6 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>63621-0356-25</NDC11Code>
<ProductNDC>63621-356</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sundrops 75</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Sunburst Chemicals, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help reduce amount of bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67544-356-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-356-12) </PackageDescription>
<NDC11Code>67544-0356-12</NDC11Code>
<ProductNDC>67544-356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viagra</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980327</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020895</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIAGRA is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>VIAGRA (sildenafil citrate), an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>68428-356-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-356-12) </PackageDescription>
<NDC11Code>68428-0356-12</NDC11Code>
<ProductNDC>68428-356</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daphne Indica</ProprietaryName>
<NonProprietaryName>Daphne Odora Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>DAPHNE ODORA BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84126-356-12</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE, PLASTIC (84126-356-12) </PackageDescription>
<NDC11Code>84126-0356-12</NDC11Code>
<ProductNDC>84126-356</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Dayquil</ProprietaryName>
<ProprietaryNameSuffix>Intense Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>1000; 30</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84126-358-24</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (84126-358-24) * 354 mL in 1 BOTTLE, PLASTIC (84126-356-12) * 354 mL in 1 BOTTLE, PLASTIC (84126-357-12) </PackageDescription>
<NDC11Code>84126-0358-24</NDC11Code>
<ProductNDC>84126-358</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Dayquil And Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Intense Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84289-356-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (84289-356-12) </PackageDescription>
<NDC11Code>84289-0356-12</NDC11Code>
<ProductNDC>84289-356</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 81mg Adult Low Dose</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>PHARMAMED USA INC</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35561-254-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-10) </PackageDescription>
<NDC11Code>35561-0254-10</NDC11Code>
<ProductNDC>35561-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-254-13</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-254-13) </PackageDescription>
<NDC11Code>35561-0254-13</NDC11Code>
<ProductNDC>35561-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-255-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-10) </PackageDescription>
<NDC11Code>35561-0255-10</NDC11Code>
<ProductNDC>35561-255</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-255-13</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-255-13) </PackageDescription>
<NDC11Code>35561-0255-13</NDC11Code>
<ProductNDC>35561-255</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-256-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-10) </PackageDescription>
<NDC11Code>35561-0256-10</NDC11Code>
<ProductNDC>35561-256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-256-13</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-13) </PackageDescription>
<NDC11Code>35561-0256-13</NDC11Code>
<ProductNDC>35561-256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-257-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-10) </PackageDescription>
<NDC11Code>35561-0257-10</NDC11Code>
<ProductNDC>35561-257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>35561-257-13</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-257-13) </PackageDescription>
<NDC11Code>35561-0257-13</NDC11Code>
<ProductNDC>35561-257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>N/a</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208824</ApplicationNumber>
<LabelerName>Bostal LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are phosphodiesterase 5 (PDE5) inhibitors indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil is selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5- yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available as round/capsule-shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, HPMC 2910/Hypromellose, titanium dioxide, macrogol/PEG, triacetin, iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>0264-3183-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3183-11</NDC11Code>
<ProductNDC>0264-3183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202106</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
</NDC>
<NDC>
<NDCCode>0264-3185-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3185-11</NDC11Code>
<ProductNDC>0264-3185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meropenem And Sodium Chloride</ProprietaryName>
<NonProprietaryName>Meropenem And Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202106</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>MEROPENEM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Penem Antibacterial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: 1 Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1) , 2 Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2) , 3 Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3) .</IndicationAndUsage>
<Description>Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S3H2O with a molecular weight of 437.52. Its structural formula is. Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).</Description>
</NDC>
<NDC>
<NDCCode>0904-6706-06</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 CARTON (0904-6706-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6706-06</NDC11Code>
<ProductNDC>0904-6706</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omega-3-acid Ethyl Esters</ProprietaryName>
<NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090973</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>OMEGA-3-ACID ETHYL ESTERS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140930</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.</IndicationAndUsage>
<Description>Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The molecular formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The molecular formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is. Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide.</Description>
</NDC>
</NDCList>