{
"NDC": [
{
"NDCCode": "50742-137-99",
"PackageDescription": "24000 TABLET, FILM COATED in 1 BOTTLE (50742-137-99)",
"NDC11Code": "50742-0137-99",
"ProductNDC": "50742-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50742-137-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (50742-137-10)",
"NDC11Code": "50742-0137-10",
"ProductNDC": "50742-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64376-137-99",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (64376-137-99) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64376-0137-99",
"ProductNDC": "64376-137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140912",
"EndMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077319",
"LabelerName": "Boca Pharmacal, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "79903-137-99",
"PackageDescription": "100 TABLET in 1 BOTTLE (79903-137-99) ",
"NDC11Code": "79903-0137-99",
"ProductNDC": "79903-137",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211544",
"LabelerName": "WAL-MART STORES INC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221129",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ premenstrual and menstrual cramps ■ the common cold ■ headache ■ toothache. ■ temporarily reduces fever."
},
{
"NDCCode": "50742-138-99",
"PackageDescription": "10000 TABLET, FILM COATED in 1 BOTTLE (50742-138-99)",
"NDC11Code": "50742-0138-99",
"ProductNDC": "50742-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50742-140-99",
"PackageDescription": "3000 TABLET, FILM COATED in 1 BOTTLE (50742-140-99)",
"NDC11Code": "50742-0140-99",
"ProductNDC": "50742-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50742-483-99",
"PackageDescription": "1 VIAL in 1 CARTON (50742-483-99) > 100 mL in 1 VIAL",
"NDC11Code": "50742-0483-99",
"ProductNDC": "50742-483",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorouracil",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209271",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191221",
"SamplePackage": "N"
},
{
"NDCCode": "50742-615-99",
"PackageDescription": "115384 TABLET, EXTENDED RELEASE in 1 DRUM (50742-615-99) ",
"NDC11Code": "50742-0615-99",
"ProductNDC": "50742-615",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5."
},
{
"NDCCode": "50742-616-99",
"PackageDescription": "57692 TABLET, EXTENDED RELEASE in 1 DRUM (50742-616-99) ",
"NDC11Code": "50742-0616-99",
"ProductNDC": "50742-616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5."
},
{
"NDCCode": "50742-617-99",
"PackageDescription": "32362 TABLET, EXTENDED RELEASE in 1 DRUM (50742-617-99) ",
"NDC11Code": "50742-0617-99",
"ProductNDC": "50742-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5."
},
{
"NDCCode": "50742-618-99",
"PackageDescription": "16181 TABLET, EXTENDED RELEASE in 1 DRUM (50742-618-99) ",
"NDC11Code": "50742-0618-99",
"ProductNDC": "50742-618",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204106",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5."
},
{
"NDCCode": "50742-496-26",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) / 26.3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0496-26",
"ProductNDC": "50742-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210383",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "50742-497-53",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0497-53",
"ProductNDC": "50742-497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210383",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "50742-498-05",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05) / 5.26 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "50742-0498-05",
"ProductNDC": "50742-498",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210383",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230701",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "50742-366-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (50742-366-30) ",
"NDC11Code": "50742-0366-30",
"ProductNDC": "50742-366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gefitinib",
"NonProprietaryName": "Gefitinib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211591",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "GEFITINIB",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230427",
"SamplePackage": "N",
"IndicationAndUsage": "Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14)].",
"Description": "Gefitinib is a kinase inhibitor. The chemical name of gefitinib is 4-Quinazolinamine N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy] and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a white-colored powder. Gefitinib is a free base. The molecule has pKas of 5.4 and 7.2. Gefitinib can be defined as sparingly soluble at pH 1, but is practically insoluble above pH 7, with the solubility decreasing sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethyl sulfoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol and acetonitrile. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate and magnesium stearate. The tablet coating is composed of polyvinyl alcohol-part hydrolysed, polyethylene glycol 3350, talc, titanium dioxide, red ferric oxide, ferrosoferric oxide and yellow ferric oxide."
},
{
"NDCCode": "0054-0293-99",
"PackageDescription": "1 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00054-0293-99",
"ProductNDC": "0054-0293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azelastine Hydrochloride",
"NonProprietaryName": "Azelastine Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20141027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091444",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "AZELASTINE HYDROCHLORIDE",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141027",
"SamplePackage": "N",
"IndicationAndUsage": "Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.",
"Description": "Azelastine Hydrochloride Nasal Spray 137 micrograms (mcg), is an antihistamine formulated as a metered-spray for intranasal administration. Azelastine hydrochloride occurs as a white to almost white solid. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O·HCl with the following chemical structure. Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays."
},
{
"NDCCode": "11523-7312-1",
"PackageDescription": "177 mL in 1 CAN (11523-7312-1) ",
"NDC11Code": "11523-7312-01",
"ProductNDC": "11523-7312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Sport Continuous",
"ProprietaryNameSuffix": "Spf 100 Plus",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140811",
"EndMarketingDate": "20210801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE",
"StrengthNumber": "137.47; 45.82; 27.49; 54.99; 91.65; 18.33",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140811",
"EndMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "11523-7312-2",
"PackageDescription": "177 mL in 1 CAN (11523-7312-2) ",
"NDC11Code": "11523-7312-02",
"ProductNDC": "11523-7312",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Sport Continuous",
"ProprietaryNameSuffix": "Spf 100 Plus",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140811",
"EndMarketingDate": "20210801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE",
"StrengthNumber": "137.47; 45.82; 27.49; 54.99; 91.65; 18.33",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140811",
"EndMarketingDatePackage": "20210801",
"SamplePackage": "N"
},
{
"NDCCode": "24090-498-99",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (24090-498-99) > 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "24090-0498-99",
"ProductNDC": "24090-498",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tirosint",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021924",
"LabelerName": "Akrimax Pharmaceuticals, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "33344-004-01",
"PackageDescription": "137 L in 1 DEWAR (33344-004-01)",
"NDC11Code": "33344-0004-01",
"ProductNDC": "33344-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrous Oxide",
"NonProprietaryName": "Nitrous Oxide",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19711101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Welding & Therapy Service Inc.",
"SubstanceName": "NITROUS OXIDE",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "40032-030-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (40032-030-01)",
"NDC11Code": "40032-0030-01",
"ProductNDC": "40032-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Monobasic Sodium Phosphate And Dibasic Sodium Phosphate",
"NonProprietaryName": "Monobasic Sodium Phosphate And Dibasic Sodium Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079247",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS",
"StrengthNumber": "1.105; .398",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.",
"Description": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is a purgative used to clean the colon prior to colonoscopy. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white modified oval shaped, biconvex, bisect on one side and plain on the other debossed “N” on the left side of bisect and “03” on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of monobasic sodium phosphate, USP and 0.398 grams of dibasic sodium phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000; and magnesium stearate. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below. Monobasic sodium phosphate, USP. Molecular Formula: NaH2PO4 H2O. Molecular Weight: 137.99. Dibasic sodium phosphate, USP. Molecular Formula: Na2HPO4. Molecular Weight: 141.96. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are for oral administration only."
},
{
"NDCCode": "54868-5889-0",
"PackageDescription": "32 TABLET in 1 BOTTLE, PLASTIC (54868-5889-0)",
"NDC11Code": "54868-5889-00",
"ProductNDC": "54868-5889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmoprep",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate, Sodium Phosphate, Dibasic Anhydrous",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021892",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS",
"StrengthNumber": "1.102; .398",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.",
"Description": "OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets, debossed with “SLX” on one side of the bisect and “102” on the other side of the bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below: 1 Sodium phosphate monobasic monohydrate, USPMolecular Formula: NaH2PO4 H2OMolecular Weight: 137.99 , 2 Sodium phosphate dibasic anhydrous, USPMolecular Formula: Na2HPO4Molecular Weight: 141.96 ."
},
{
"NDCCode": "54868-5889-1",
"PackageDescription": "4 TABLET in 1 BOTTLE, PLASTIC (54868-5889-1)",
"NDC11Code": "54868-5889-01",
"ProductNDC": "54868-5889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Osmoprep",
"NonProprietaryName": "Sodium Phosphate, Monobasic, Monohydrate, Sodium Phosphate, Dibasic Anhydrous",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080530",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021892",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS",
"StrengthNumber": "1.102; .398",
"StrengthUnit": "g/1; g/1",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.",
"Description": "OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets, debossed with “SLX” on one side of the bisect and “102” on the other side of the bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below: 1 Sodium phosphate monobasic monohydrate, USPMolecular Formula: NaH2PO4 H2OMolecular Weight: 137.99 , 2 Sodium phosphate dibasic anhydrous, USPMolecular Formula: Na2HPO4Molecular Weight: 141.96 ."
},
{
"NDCCode": "59651-554-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-554-99) ",
"NDC11Code": "59651-0554-99",
"ProductNDC": "59651-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216414",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "137",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing."
},
{
"NDCCode": "59651-555-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-555-99) ",
"NDC11Code": "59651-0555-99",
"ProductNDC": "59651-555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216414",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing."
},
{
"NDCCode": "59651-556-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-556-99) ",
"NDC11Code": "59651-0556-99",
"ProductNDC": "59651-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216414",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing."
},
{
"NDCCode": "59651-557-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-557-99) ",
"NDC11Code": "59651-0557-99",
"ProductNDC": "59651-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216414",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing."
},
{
"NDCCode": "59651-558-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-558-99) ",
"NDC11Code": "59651-0558-99",
"ProductNDC": "59651-558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240716",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "300",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
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"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing."
},
{
"NDCCode": "76436-137-05",
"PackageDescription": "142 g in 1 BOX (76436-137-05)",
"NDC11Code": "76436-0137-05",
"ProductNDC": "76436-137",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dusting Powder",
"NonProprietaryName": "Talc",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Viny Health and Beauty Inc",
"SubstanceName": "TALC",
"StrengthNumber": "99",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "50742-101-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (50742-101-01)",
"NDC11Code": "50742-0101-01",
"ProductNDC": "50742-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
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}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<SubstanceName>SIMVASTATIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
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<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
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<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077319</ApplicationNumber>
<LabelerName>Boca Pharmacal, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
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<PackageDescription>100 TABLET in 1 BOTTLE (79903-137-99) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ premenstrual and menstrual cramps ■ the common cold ■ headache ■ toothache. ■ temporarily reduces fever.</IndicationAndUsage>
</NDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<PackageDescription>3000 TABLET, FILM COATED in 1 BOTTLE (50742-140-99)</PackageDescription>
<NDC11Code>50742-0140-99</NDC11Code>
<ProductNDC>50742-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
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<PackageDescription>1 VIAL in 1 CARTON (50742-483-99) > 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>50742-0483-99</NDC11Code>
<ProductNDC>50742-483</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorouracil</ProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<RouteName>ORAL</RouteName>
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<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
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<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5.</Description>
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<ProductNDC>50742-616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
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<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5.</Description>
</NDC>
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<PackageDescription>32362 TABLET, EXTENDED RELEASE in 1 DRUM (50742-617-99) </PackageDescription>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204106</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5.</Description>
</NDC>
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<PackageDescription>16181 TABLET, EXTENDED RELEASE in 1 DRUM (50742-618-99) </PackageDescription>
<NDC11Code>50742-0618-99</NDC11Code>
<ProductNDC>50742-618</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20180206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate， USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. * may be replaced by talc.Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>50742-496-26</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) / 26.3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0496-26</NDC11Code>
<ProductNDC>50742-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210383</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50742-497-53</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0497-53</NDC11Code>
<ProductNDC>50742-497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210383</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50742-498-05</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05) / 5.26 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>50742-0498-05</NDC11Code>
<ProductNDC>50742-498</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210383</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1), 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2), 3 in combination with cisplatin for the treatment of non-small cell lung cancer. (1.3), 4 as a single agent for the treatment of pancreatic cancer. (1.4).</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl, USP is 2´-. deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer).The structural formula is as follows. Gemcitabine HCl, USP is a white to off-white solid with a molecular formula of C9H11F2N3O4 HCl and a molecular weight of 299.66 g/mol. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine Injection is a sterile solution in single-dose vials for intravenous use. Each vial contains 200 mg, 1 g, or 2 g of gemcitabine equivalent to 227.57 mg, 1.137 g, or 2.275 g of gemcitabine HCl, USP. Each mL contains 38 mg of gemcitabine free base in Water for Injection equivalent to 43.26 mg of gemcitabine HCl, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50742-366-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (50742-366-30) </PackageDescription>
<NDC11Code>50742-0366-30</NDC11Code>
<ProductNDC>50742-366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gefitinib</ProprietaryName>
<NonProprietaryName>Gefitinib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211591</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GEFITINIB</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)]. Limitation of Use: Safety and efficacy of gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Gefitinib is a kinase inhibitor. The chemical name of gefitinib is 4-Quinazolinamine N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy] and the following structural formula. Gefitinib has the molecular formula C22H24ClFN4O3, a relative molecular mass of 446.9 daltons and is a white-colored powder. Gefitinib is a free base. The molecule has pKas of 5.4 and 7.2. Gefitinib can be defined as sparingly soluble at pH 1, but is practically insoluble above pH 7, with the solubility decreasing sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethyl sulfoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol and acetonitrile. Gefitinib tablets are available as brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate and magnesium stearate. The tablet coating is composed of polyvinyl alcohol-part hydrolysed, polyethylene glycol 3350, talc, titanium dioxide, red ferric oxide, ferrosoferric oxide and yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0054-0293-99</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0054-0293-99) > 200 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00054-0293-99</NDC11Code>
<ProductNDC>0054-0293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
<NonProprietaryName>Azelastine Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20141027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091444</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.</IndicationAndUsage>
<Description>Azelastine Hydrochloride Nasal Spray 137 micrograms (mcg), is an antihistamine formulated as a metered-spray for intranasal administration. Azelastine hydrochloride occurs as a white to almost white solid. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3O·HCl with the following chemical structure. Azelastine Hydrochloride Nasal Spray contains 0.1% azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride, citric acid anhydrous, dibasic sodium phosphate dodecahydrate, edetate disodium, hypromellose, purified water and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.</Description>
</NDC>
<NDC>
<NDCCode>11523-7312-1</NDCCode>
<PackageDescription>177 mL in 1 CAN (11523-7312-1) </PackageDescription>
<NDC11Code>11523-7312-01</NDC11Code>
<ProductNDC>11523-7312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Sport Continuous</ProprietaryName>
<ProprietaryNameSuffix>Spf 100 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140811</StartMarketingDate>
<EndMarketingDate>20210801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE</SubstanceName>
<StrengthNumber>137.47; 45.82; 27.49; 54.99; 91.65; 18.33</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140811</StartMarketingDatePackage>
<EndMarketingDatePackage>20201201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11523-7312-2</NDCCode>
<PackageDescription>177 mL in 1 CAN (11523-7312-2) </PackageDescription>
<NDC11Code>11523-7312-02</NDC11Code>
<ProductNDC>11523-7312</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Sport Continuous</ProprietaryName>
<ProprietaryNameSuffix>Spf 100 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140811</StartMarketingDate>
<EndMarketingDate>20210801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE</SubstanceName>
<StrengthNumber>137.47; 45.82; 27.49; 54.99; 91.65; 18.33</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140811</StartMarketingDatePackage>
<EndMarketingDatePackage>20210801</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24090-498-99</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (24090-498-99) > 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24090-0498-99</NDC11Code>
<ProductNDC>24090-498</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tirosint</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021924</ApplicationNumber>
<LabelerName>Akrimax Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>33344-004-01</NDCCode>
<PackageDescription>137 L in 1 DEWAR (33344-004-01)</PackageDescription>
<NDC11Code>33344-0004-01</NDC11Code>
<ProductNDC>33344-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrous Oxide</ProprietaryName>
<NonProprietaryName>Nitrous Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19711101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Welding & Therapy Service Inc.</LabelerName>
<SubstanceName>NITROUS OXIDE</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>40032-030-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (40032-030-01)</PackageDescription>
<NDC11Code>40032-0030-01</NDC11Code>
<ProductNDC>40032-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Monobasic Sodium Phosphate And Dibasic Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Monobasic Sodium Phosphate And Dibasic Sodium Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079247</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS</SubstanceName>
<StrengthNumber>1.105; .398</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.</IndicationAndUsage>
<Description>Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is a purgative used to clean the colon prior to colonoscopy. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are white to off-white modified oval shaped, biconvex, bisect on one side and plain on the other debossed “N” on the left side of bisect and “03” on the right side of the bisect. Each Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet contains 1.102 grams of monobasic sodium phosphate, USP and 0.398 grams of dibasic sodium phosphate, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000; and magnesium stearate. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablet is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below. Monobasic sodium phosphate, USP. Molecular Formula: NaH2PO4 H2O. Molecular Weight: 137.99. Dibasic sodium phosphate, USP. Molecular Formula: Na2HPO4. Molecular Weight: 141.96. Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are for oral administration only.</Description>
</NDC>
<NDC>
<NDCCode>54868-5889-0</NDCCode>
<PackageDescription>32 TABLET in 1 BOTTLE, PLASTIC (54868-5889-0)</PackageDescription>
<NDC11Code>54868-5889-00</NDC11Code>
<ProductNDC>54868-5889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmoprep</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate, Sodium Phosphate, Dibasic Anhydrous</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021892</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS</SubstanceName>
<StrengthNumber>1.102; .398</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.</IndicationAndUsage>
<Description>OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets, debossed with “SLX” on one side of the bisect and “102” on the other side of the bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below: 1 Sodium phosphate monobasic monohydrate, USPMolecular Formula: NaH2PO4 H2OMolecular Weight: 137.99 , 2 Sodium phosphate dibasic anhydrous, USPMolecular Formula: Na2HPO4Molecular Weight: 141.96 .</Description>
</NDC>
<NDC>
<NDCCode>54868-5889-1</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE, PLASTIC (54868-5889-1)</PackageDescription>
<NDC11Code>54868-5889-01</NDC11Code>
<ProductNDC>54868-5889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Osmoprep</ProprietaryName>
<NonProprietaryName>Sodium Phosphate, Monobasic, Monohydrate, Sodium Phosphate, Dibasic Anhydrous</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080530</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021892</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS</SubstanceName>
<StrengthNumber>1.102; .398</StrengthNumber>
<StrengthUnit>g/1; g/1</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.</IndicationAndUsage>
<Description>OsmoPrep® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) is a purgative used to clean the colon prior to colonoscopy. OsmoPrep is manufactured with a highly soluble tablet binder and does not contain microcrystalline cellulose (MCC). OsmoPrep Tablets are oval, white to off-white compressed tablets, debossed with “SLX” on one side of the bisect and “102” on the other side of the bisect. Each OsmoPrep tablet contains 1.102 grams of sodium phosphate monobasic monohydrate, USP and 0.398 grams of sodium phosphate dibasic anhydrous, USP for a total of 1.5 grams of sodium phosphate per tablet. Inert ingredients include polyethylene glycol 8000, NF; and magnesium stearate, NF. OsmoPrep is gluten-free. The structural and molecular formulae and molecular weights of the active ingredients are shown below: 1 Sodium phosphate monobasic monohydrate, USPMolecular Formula: NaH2PO4 H2OMolecular Weight: 137.99 , 2 Sodium phosphate dibasic anhydrous, USPMolecular Formula: Na2HPO4Molecular Weight: 141.96 .</Description>
</NDC>
<NDC>
<NDCCode>59651-554-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-554-99) </PackageDescription>
<NDC11Code>59651-0554-99</NDC11Code>
<ProductNDC>59651-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216414</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>137</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>59651-555-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-555-99) </PackageDescription>
<NDC11Code>59651-0555-99</NDC11Code>
<ProductNDC>59651-555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216414</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>59651-556-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-556-99) </PackageDescription>
<NDC11Code>59651-0556-99</NDC11Code>
<ProductNDC>59651-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216414</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>59651-557-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-557-99) </PackageDescription>
<NDC11Code>59651-0557-99</NDC11Code>
<ProductNDC>59651-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216414</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>59651-558-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-558-99) </PackageDescription>
<NDC11Code>59651-0558-99</NDC11Code>
<ProductNDC>59651-558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216414</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 (anhydrous), and structural formula as shown. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet, USP contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, gelatin, maltodextrin, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. Levothyroxine sodium tablets contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength:Table 9: Levothyroxine Sodium Tablet Color Additives. * Note – FD&C Yellow No. 6 is orange in color. FDA approved dissolution method and acceptance criterion differs from the USP monograph dissolution testing.</Description>
</NDC>
<NDC>
<NDCCode>76436-137-05</NDCCode>
<PackageDescription>142 g in 1 BOX (76436-137-05)</PackageDescription>
<NDC11Code>76436-0137-05</NDC11Code>
<ProductNDC>76436-137</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dusting Powder</ProprietaryName>
<NonProprietaryName>Talc</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Viny Health and Beauty Inc</LabelerName>
<SubstanceName>TALC</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>50742-101-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (50742-101-01)</PackageDescription>
<NDC11Code>50742-0101-01</NDC11Code>
<ProductNDC>50742-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>