{
"NDC": [
{
"NDCCode": "50419-407-00",
"PackageDescription": "90 BLISTER PACK in 1 PACKAGE (50419-407-00) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50419-0407-00",
"ProductNDC": "50419-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beyaz",
"NonProprietaryName": "Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium",
"DosageFormName": "KIT",
"StartMarketingDate": "20101007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022532",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101007",
"SamplePackage": "N",
"IndicationAndUsage": "Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3), 4 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.4).",
"Description": "Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium ."
},
{
"NDCCode": "50419-407-03",
"PackageDescription": "3 BLISTER PACK in 1 PACKAGE (50419-407-03) / 1 KIT in 1 BLISTER PACK (50419-407-01) ",
"NDC11Code": "50419-0407-03",
"ProductNDC": "50419-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beyaz",
"NonProprietaryName": "Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium",
"DosageFormName": "KIT",
"StartMarketingDate": "20101007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022532",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101007",
"SamplePackage": "N",
"IndicationAndUsage": "Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3), 4 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.4).",
"Description": "Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium ."
},
{
"NDCCode": "50419-407-70",
"PackageDescription": "90 BLISTER PACK in 1 PACKAGE (50419-407-70) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50419-0407-70",
"ProductNDC": "50419-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beyaz",
"NonProprietaryName": "Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium",
"DosageFormName": "KIT",
"StartMarketingDate": "20101007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022532",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101007",
"SamplePackage": "N",
"IndicationAndUsage": "Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3), 4 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.4).",
"Description": "Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium ."
},
{
"NDCCode": "50419-407-75",
"PackageDescription": "12 PACKAGE in 1 CARTON (50419-407-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-407-71) ",
"NDC11Code": "50419-0407-75",
"ProductNDC": "50419-407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beyaz",
"NonProprietaryName": "Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium",
"DosageFormName": "KIT",
"StartMarketingDate": "20101007",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022532",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101007",
"SamplePackage": "N",
"IndicationAndUsage": "Beyaz is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2), 3 Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3), 4 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.4).",
"Description": "Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium ."
},
{
"NDCCode": "50988-407-00",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (50988-407-00)",
"NDC11Code": "50988-0407-00",
"ProductNDC": "50988-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shopko Antibacterial Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120702",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Jets, Sets, & Elephants Beauty Corp.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To decrease bacteria on the skin and clean hands. Recommended for repeated use."
},
{
"NDCCode": "69842-407-00",
"PackageDescription": "1 KIT in 1 KIT (69842-407-00) * .7 mL in 1 PACKAGE (44224-0001-2)",
"NDC11Code": "69842-0407-00",
"ProductNDC": "69842-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health First Aid Outdoor Prep-pack",
"NonProprietaryName": "Ammonia",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "CVS",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irriatation and itching due to : 1 insect bites and stings, 2 poison ivy, oak or sumac ."
},
{
"NDCCode": "70956-407-00",
"PackageDescription": "1 BOTTLE in 1 BOX (70956-407-00) > 30 mL in 1 BOTTLE",
"NDC11Code": "70956-0407-00",
"ProductNDC": "70956-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jafra Long Wear Makeup Broad Spectrum Spf 20 Sable D6",
"NonProprietaryName": "Octisalate, Zinc Oxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161129",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Absara Cosmetics S.A.P.I DE C.V.",
"SubstanceName": "OCTISALATE; ZINC OXIDE",
"StrengthNumber": "30; 68.2",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-07-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161129",
"SamplePackage": "N"
},
{
"NDCCode": "75839-407-00",
"PackageDescription": "1000 g in 1 CONTAINER (75839-407-00)",
"NDC11Code": "75839-0407-00",
"ProductNDC": "75839-407",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vecuronium Bromide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20141124",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Attix Pharmaceuticals Inc",
"SubstanceName": "VECURONIUM BROMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "83524-407-00",
"PackageDescription": "120 mL in 1 JAR (83524-407-00) ",
"NDC11Code": "83524-0407-00",
"ProductNDC": "83524-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermoia Manuka Honey Eczema Cream",
"NonProprietaryName": "Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "TREASUREWISE LLC",
"SubstanceName": "OATMEAL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230605",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to:. rashes. eczema. poison ivy, oak, or sumac. insect bites."
},
{
"NDCCode": "50419-171-00",
"PackageDescription": "210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50419-0171-00",
"ProductNDC": "50419-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stivarga",
"NonProprietaryName": "Regorafenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203085",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "REGORAFENIB",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120927",
"SamplePackage": "N",
"IndicationAndUsage": "STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .",
"Description": "STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3 H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with \"BAYER\" on one side and \"40\" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide."
},
{
"NDCCode": "50419-403-00",
"PackageDescription": "90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50419-0403-00",
"ProductNDC": "50419-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Safyral",
"NonProprietaryName": "Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium",
"DosageFormName": "KIT",
"StartMarketingDate": "20120213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022574",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120213",
"SamplePackage": "N",
"IndicationAndUsage": "Safyral is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2).",
"Description": "Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 21 orange tablets each containing 3 mg DRSP, 0.03 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 7 light orange tablets each containing 0.451 mg levomefolate calcium ."
},
{
"NDCCode": "50419-409-00",
"PackageDescription": "90 BLISTER PACK in 1 PACKAGE (50419-409-00) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50419-0409-00",
"ProductNDC": "50419-409",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Natazia",
"NonProprietaryName": "Estradiol Valerate And Estradiol Valerate/dienogest",
"DosageFormName": "KIT",
"StartMarketingDate": "20100506",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022252",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100506",
"SamplePackage": "N",
"IndicationAndUsage": "Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1) . The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m2 has not been evaluated. (1, 8.8). Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. (1.2).",
"Description": "Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets: 1 2 dark yellow tablets each containing 3 mg estradiol valerate , 2 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest , 3 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest , 4 2 dark red tablets each containing 1 mg estradiol valerate , 5 2 white tablets (inert)."
},
{
"NDCCode": "50419-522-00",
"PackageDescription": "280 VIAL in 1 TRAY (50419-522-00) > 3 mL in 1 VIAL",
"NDC11Code": "50419-0522-00",
"ProductNDC": "50419-522",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Interferon Beta-1b",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"StartMarketingDate": "20120229",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "INTERFERON BETA-1B",
"StrengthNumber": ".3",
"StrengthUnit": "mg/3mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50419-788-00",
"PackageDescription": "38220 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (50419-788-00)",
"NDC11Code": "50419-0788-00",
"ProductNDC": "50419-788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cipro",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021473",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "212.6; 287.5",
"StrengthUnit": "mg/1; 1/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-05-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50419-789-00",
"PackageDescription": "19380 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (50419-789-00)",
"NDC11Code": "50419-0789-00",
"ProductNDC": "50419-789",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cipro",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021473",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "452.2; 574.9",
"StrengthUnit": "mg/1; 1/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-05-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0024-4142-00",
"PackageDescription": "6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) ",
"NDC11Code": "00024-4142-00",
"ProductNDC": "0024-4142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multaq",
"NonProprietaryName": "Dronedarone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022425",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DRONEDARONE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240601",
"SamplePackage": "Y",
"IndicationAndUsage": "MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].",
"Description": "Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide."
},
{
"NDCCode": "0024-4142-06",
"PackageDescription": "8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) ",
"NDC11Code": "00024-4142-06",
"ProductNDC": "0024-4142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multaq",
"NonProprietaryName": "Dronedarone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022425",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "DRONEDARONE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090701",
"SamplePackage": "Y",
"IndicationAndUsage": "MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].",
"Description": "Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide."
},
{
"NDCCode": "42254-054-00",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (42254-054-00)",
"NDC11Code": "42254-0054-00",
"ProductNDC": "42254-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077662",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults.",
"Description": "Gabapentin Tablets USP are supplied as oval shaped, film-coated, biconvex scored tablets containing 600 mg and 800mg of gabapentin USP. The inactive ingredients for the tablets are Corn Starch, Copovidone, Poloxamer 407, Magnesium Stearate, Polyethylene Glycol, Hypromellose, Titanium Dioxide, Talc, Macrogol, Polysorbate 80 and purified water. Gabapentin USP is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25."
},
{
"NDCCode": "50090-1085-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0) ",
"NDC11Code": "50090-1085-00",
"ProductNDC": "50090-1085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isentress",
"NonProprietaryName": "Raltegravir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071012",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022145",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "RALTEGRAVIR POTASSIUM",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).",
"Description": "ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose."
},
{
"NDCCode": "50090-1188-0",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-1188-0) ",
"NDC11Code": "50090-1188-00",
"ProductNDC": "50090-1188",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefprozil",
"NonProprietaryName": "Cefprozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20051223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065208",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFPROZIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
"Description": "Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil, USP is a cis and trans isomeric mixture (≥ 90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. C18H19N3O5SH2O M.W. 407.45. Cefprozil, USP is a white to yellowish powder. Cefprozil Tablets USP are intended for oral administration. Cefprozil Tablets USP contain cefprozil, USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 250 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "50090-1241-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-1241-0) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-1241-00",
"ProductNDC": "50090-1241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Besivance",
"NonProprietaryName": "Besifloxacin",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022308",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BESIFLOXACIN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria. Aerococcus viridans*. CDC coryneform group G. Corynebacterium pseudodiphtheriticum*. Corynebacterium striatum*. Haemophilus influenzae. Moraxella catarrhalis*. Moraxella lacunata*. Pseudomonas aeruginosa*. Staphylococcus aureus. Staphylococcus epidermidis. Staphylococcus hominis*. Staphylococcus lugdunensis*. Staphylococcus warneri*. Streptococcus mitis group. Streptococcus oralis. Streptococcus pneumoniae. Streptococcus salivarius*. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite®† (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of BESIVANCE contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use. C19H21ClFN3O3HCl. Molecular Weight 430.30. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active: besifloxacin 0.6% (6 mg/mL);. Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative: benzalkonium chloride 0.01%. BESIVANCE is an isotonic suspension with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "50090-1710-0",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-1710-0) ",
"NDC11Code": "50090-1710-00",
"ProductNDC": "50090-1710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefprozil",
"NonProprietaryName": "Cefprozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065340",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFPROZIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150225",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.",
"Description": "Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl) acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil tablets USP are intended for oral administration.Cefprozil tablets USP contain cefprozil USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. The 250 mg tablets also contain FD&C Yellow #6 aluminum lake. The tablets are imprinted with edible ink containing shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide."
},
{
"NDCCode": "50090-1739-0",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-1739-0) ",
"NDC11Code": "50090-1739-00",
"ProductNDC": "50090-1739",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefprozil",
"NonProprietaryName": "Cefprozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065340",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFPROZIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150311",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACTAcute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.",
"Description": "Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil tablets USP are intended for oral administration. Cefprozil tablets USP contain cefprozil USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. The 250 mg tablets also contain FD&C Yellow #6 aluminum lake. The tablets are imprinted with edible ink containing shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide."
},
{
"NDCCode": "50090-2539-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-2539-0) ",
"NDC11Code": "50090-2539-00",
"ProductNDC": "50090-2539",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206402",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161024",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: Maize Starch, Poloxamer 407, Copovidone, Ethanol absolute, Hydroxy Propyl Cellulose, Magnesium Stearate, Hydroxy Propyl cellulose, Talc and Purified Water."
},
{
"NDCCode": "50090-3226-0",
"PackageDescription": "50 mL in 1 BOTTLE (50090-3226-0) ",
"NDC11Code": "50090-3226-00",
"ProductNDC": "50090-3226",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefprozil",
"NonProprietaryName": "Cefprozil",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20070130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065381",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEFPROZIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171030",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.",
"Description": "Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil, USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil for oral suspension, USP is intended for oral administration. Cefprozil for oral suspension, USP contains cefprozil USP equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid monohydrate, colloidal silicon dioxide, FD&C Red No.3, glycine, polysorbate 80, simethicone emulsion, sodium benzoate, sodium chloride, bubble gum flavor and sucrose."
},
{
"NDCCode": "50090-3317-0",
"PackageDescription": "33 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3317-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "50090-3317-00",
"ProductNDC": "50090-3317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202045",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180103",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major Depressive Disorder [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)], 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88 g/mol. The structural formula is:. Duloxetine hydrochloride is a white to off-white powder, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.5 mg, 33.7 mg, or 67.4 mg of duloxetine hydrochloride equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include dibutyl sebacate, FD&C Blue No. 2, gelatin, hypromellose, methylcellulose, poloxamer 407, polyvinyl acetate phthalate, talc, and titanium dioxide. The 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink of the 20 mg capsules contains shellac, iron oxide black, propylene glycol and ammonium hydroxide. The imprinting ink of the 30 mg capsules contains shellac, propylene glycol, ammonia, potassium hydroxide, iron oxide black, and iron oxide yellow. The imprinting ink of the 60 mg capsules contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "50090-4723-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-4723-0) ",
"NDC11Code": "50090-4723-00",
"ProductNDC": "50090-4723",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205101",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20191115",
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"IndicationAndUsage": "Gabapentin is indicated for: 1 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and opadry white (03F180003). Opadry white (03F180003) contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205101",
"LabelerName": "A-S Medication Solutions",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "50090-7208-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-7208-0) ",
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"ProductNDC": "50090-7208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216798",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240805",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white, crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer 407, polydextrose, polyethylene glycol, titanium dioxide, and triacetin. In addition, 54 mg individual tablets contain: D&C Yellow # 10 and FD&C Yellow # 6. Meets USP dissolution test 3."
},
{
"NDCCode": "50090-7209-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-7209-0) ",
"NDC11Code": "50090-7209-00",
"ProductNDC": "50090-7209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216798",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240805",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white, crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer 407, polydextrose, polyethylene glycol, titanium dioxide, and triacetin. In addition, 54 mg individual tablets contain: D&C Yellow # 10 and FD&C Yellow # 6. Meets USP dissolution test 3."
}
]
}
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<Description>Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium .</Description>
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<Description>Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium .</Description>
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<PackageDescription>12 PACKAGE in 1 CARTON (50419-407-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-407-71) </PackageDescription>
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<Description>Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 4 light orange tablets each containing 0.451 mg levomefolate calcium .</Description>
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<IndicationAndUsage>Temporarily protects and helps relieve minor skin irriatation and itching due to : 1 insect bites and stings, 2 poison ivy, oak or sumac .</IndicationAndUsage>
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<Status>Deprecated</Status>
<LastUpdate>2022-07-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>1000 g in 1 CONTAINER (75839-407-00)</PackageDescription>
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<ProductNDC>75839-407</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
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<LabelerName>Attix Pharmaceuticals Inc</LabelerName>
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>83524-407-00</NDCCode>
<PackageDescription>120 mL in 1 JAR (83524-407-00) </PackageDescription>
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<ProductNDC>83524-407</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermoia Manuka Honey Eczema Cream</ProprietaryName>
<NonProprietaryName>Oatmeal</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>TREASUREWISE LLC</LabelerName>
<SubstanceName>OATMEAL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve minor skin irritation and itching due to:. rashes. eczema. poison ivy, oak, or sumac. insect bites.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50419-171-00</NDCCode>
<PackageDescription>210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50419-0171-00</NDC11Code>
<ProductNDC>50419-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stivarga</ProprietaryName>
<NonProprietaryName>Regorafenib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203085</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>REGORAFENIB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: 1 Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. (1.1), 2 Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2), 3 Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (1.3) .</IndicationAndUsage>
<Description>STIVARGA (regorafenib) is a multikinase inhibitor with the chemical name 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate. Regorafenib has the following structural formula. Regorafenib is a monohydrate and it has a molecular formula C21H15ClF4N4O3 H2O and a molecular weight of 500.83. Regorafenib is practically insoluble in water, slightly soluble in acetonitrile, methanol, ethanol, and ethyl acetate and sparingly soluble in acetone. STIVARGA tablets for oral administration are formulated as light pink, oval-shaped tablets debossed with "BAYER" on one side and "40" on the other. Each tablet contains 40 mg of regorafenib in the anhydrous state, which corresponds to 41.49 mg of regorafenib monohydrate, and the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, and colloidal silicon dioxide. The film-coating contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lecithin (soy), polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50419-403-00</NDCCode>
<PackageDescription>90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50419-0403-00</NDC11Code>
<ProductNDC>50419-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Safyral</ProprietaryName>
<NonProprietaryName>Drospirenone/ethinyl Estradiol/levomefolate Calcium And Levomefolate Calcium</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022574</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Safyral is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2).</IndicationAndUsage>
<Description>Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 1 21 orange tablets each containing 3 mg DRSP, 0.03 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium , 2 7 light orange tablets each containing 0.451 mg levomefolate calcium .</Description>
</NDC>
<NDC>
<NDCCode>50419-409-00</NDCCode>
<PackageDescription>90 BLISTER PACK in 1 PACKAGE (50419-409-00) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50419-0409-00</NDC11Code>
<ProductNDC>50419-409</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Natazia</ProprietaryName>
<NonProprietaryName>Estradiol Valerate And Estradiol Valerate/dienogest</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100506</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022252</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1) . The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m2 has not been evaluated. (1, 8.8). Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. (1.2).</IndicationAndUsage>
<Description>Natazia (estradiol valerate and estradiol valerate/dienogest) tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets: 1 2 dark yellow tablets each containing 3 mg estradiol valerate , 2 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest , 3 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest , 4 2 dark red tablets each containing 1 mg estradiol valerate , 5 2 white tablets (inert).</Description>
</NDC>
<NDC>
<NDCCode>50419-522-00</NDCCode>
<PackageDescription>280 VIAL in 1 TRAY (50419-522-00) > 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>50419-0522-00</NDC11Code>
<ProductNDC>50419-522</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Interferon Beta-1b</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20120229</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INTERFERON BETA-1B</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50419-788-00</NDCCode>
<PackageDescription>38220 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (50419-788-00)</PackageDescription>
<NDC11Code>50419-0788-00</NDC11Code>
<ProductNDC>50419-788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cipro</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021473</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>212.6; 287.5</StrengthNumber>
<StrengthUnit>mg/1; 1/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50419-789-00</NDCCode>
<PackageDescription>19380 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (50419-789-00)</PackageDescription>
<NDC11Code>50419-0789-00</NDC11Code>
<ProductNDC>50419-789</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cipro</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021473</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>452.2; 574.9</StrengthNumber>
<StrengthUnit>mg/1; 1/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0024-4142-00</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) </PackageDescription>
<NDC11Code>00024-4142-00</NDC11Code>
<ProductNDC>0024-4142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multaq</ProprietaryName>
<NonProprietaryName>Dronedarone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022425</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DRONEDARONE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240601</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0024-4142-06</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) </PackageDescription>
<NDC11Code>00024-4142-06</NDC11Code>
<ProductNDC>0024-4142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multaq</ProprietaryName>
<NonProprietaryName>Dronedarone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022425</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>DRONEDARONE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090701</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dronedarone HCl is a benzofuran derivative with the following chemical name. N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol. Its empirical formula is C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:. MULTAQ is provided as tablets for oral administration. Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base). The inactive ingredients are: 1 Core of the tablets: Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 407, starch., 2 Coating/polishing of the tablets: Carnauba wax, hypromellose, polyethylene glycol 6000, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42254-054-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (42254-054-00)</PackageDescription>
<NDC11Code>42254-0054-00</NDC11Code>
<ProductNDC>42254-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077662</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults.</IndicationAndUsage>
<Description>Gabapentin Tablets USP are supplied as oval shaped, film-coated, biconvex scored tablets containing 600 mg and 800mg of gabapentin USP. The inactive ingredients for the tablets are Corn Starch, Copovidone, Poloxamer 407, Magnesium Stearate, Polyethylene Glycol, Hypromellose, Titanium Dioxide, Talc, Macrogol, Polysorbate 80 and purified water. Gabapentin USP is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.</Description>
</NDC>
<NDC>
<NDCCode>50090-1085-0</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0) </PackageDescription>
<NDC11Code>50090-1085-00</NDC11Code>
<ProductNDC>50090-1085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isentress</ProprietaryName>
<NonProprietaryName>Raltegravir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071012</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022145</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>RALTEGRAVIR POTASSIUM</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).</IndicationAndUsage>
<Description>ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>50090-1188-0</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (50090-1188-0) </PackageDescription>
<NDC11Code>50090-1188-00</NDC11Code>
<ProductNDC>50090-1188</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefprozil</ProprietaryName>
<NonProprietaryName>Cefprozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065208</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFPROZIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.</IndicationAndUsage>
<Description>Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil, USP is a cis and trans isomeric mixture (≥ 90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. C18H19N3O5SH2O M.W. 407.45. Cefprozil, USP is a white to yellowish powder. Cefprozil Tablets USP are intended for oral administration. Cefprozil Tablets USP contain cefprozil, USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 250 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-1241-0</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (50090-1241-0) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50090-1241-00</NDC11Code>
<ProductNDC>50090-1241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Besivance</ProprietaryName>
<NonProprietaryName>Besifloxacin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20090528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022308</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>BESIFLOXACIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria. Aerococcus viridans*. CDC coryneform group G. Corynebacterium pseudodiphtheriticum*. Corynebacterium striatum*. Haemophilus influenzae. Moraxella catarrhalis*. Moraxella lacunata*. Pseudomonas aeruginosa*. Staphylococcus aureus. Staphylococcus epidermidis. Staphylococcus hominis*. Staphylococcus lugdunensis*. Staphylococcus warneri*. Streptococcus mitis group. Streptococcus oralis. Streptococcus pneumoniae. Streptococcus salivarius*. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite®† (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). Each mL of BESIVANCE contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use. C19H21ClFN3O3HCl. Molecular Weight 430.30. Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride. Besifloxacin hydrochloride is a white to pale yellowish-white powder. Each mL contains. Active: besifloxacin 0.6% (6 mg/mL);. Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative: benzalkonium chloride 0.01%. BESIVANCE is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>50090-1710-0</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (50090-1710-0) </PackageDescription>
<NDC11Code>50090-1710-00</NDC11Code>
<ProductNDC>50090-1710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefprozil</ProprietaryName>
<NonProprietaryName>Cefprozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065340</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFPROZIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.</IndicationAndUsage>
<Description>Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl) acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil tablets USP are intended for oral administration.Cefprozil tablets USP contain cefprozil USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. The 250 mg tablets also contain FD&C Yellow #6 aluminum lake. The tablets are imprinted with edible ink containing shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-1739-0</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (50090-1739-0) </PackageDescription>
<NDC11Code>50090-1739-00</NDC11Code>
<ProductNDC>50090-1739</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefprozil</ProprietaryName>
<NonProprietaryName>Cefprozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065340</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFPROZIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACTAcute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.</IndicationAndUsage>
<Description>Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic.Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil tablets USP are intended for oral administration. Cefprozil tablets USP contain cefprozil USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. The 250 mg tablets also contain FD&C Yellow #6 aluminum lake. The tablets are imprinted with edible ink containing shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-2539-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-2539-0) </PackageDescription>
<NDC11Code>50090-2539-00</NDC11Code>
<ProductNDC>50090-2539</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206402</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin Tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: Maize Starch, Poloxamer 407, Copovidone, Ethanol absolute, Hydroxy Propyl Cellulose, Magnesium Stearate, Hydroxy Propyl cellulose, Talc and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>50090-3226-0</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (50090-3226-0) </PackageDescription>
<NDC11Code>50090-3226-00</NDC11Code>
<ProductNDC>50090-3226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefprozil</ProprietaryName>
<NonProprietaryName>Cefprozil</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065381</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CEFPROZIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. UPPER RESPIRATORY TRACT Pharyngitis/tonsillitis caused by Streptococcus pyogenes. NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present. Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to β-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific β-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing β-lactamase inhibitors. Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). LOWER RESPIRATORY TRACT Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including β-lactamase-producing strains). SKIN AND SKIN STRUCTURE Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.</IndicationAndUsage>
<Description>Cefprozil is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil is a cis and trans isomeric mixture (≥90% cis). The chemical name for the monohydrate is (6R,7R)-7-[(R)-2-Amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is. Cefprozil, USP is a white to yellowish powder with a molecular formula for the monohydrate of C18H19N3O5SH2O and a molecular weight of 407.45. Cefprozil for oral suspension, USP is intended for oral administration. Cefprozil for oral suspension, USP contains cefprozil USP equivalent to 125 mg or 250 mg anhydrous cefprozil per 5 mL constituted suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid monohydrate, colloidal silicon dioxide, FD&C Red No.3, glycine, polysorbate 80, simethicone emulsion, sodium benzoate, sodium chloride, bubble gum flavor and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>50090-3317-0</NDCCode>
<PackageDescription>33 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3317-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-3317-00</NDC11Code>
<ProductNDC>50090-3317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202045</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major Depressive Disorder [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)], 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88 g/mol. The structural formula is:. Duloxetine hydrochloride is a white to off-white powder, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.5 mg, 33.7 mg, or 67.4 mg of duloxetine hydrochloride equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include dibutyl sebacate, FD&C Blue No. 2, gelatin, hypromellose, methylcellulose, poloxamer 407, polyvinyl acetate phthalate, talc, and titanium dioxide. The 20 mg and 60 mg capsules also contain iron oxide yellow. The imprinting ink of the 20 mg capsules contains shellac, iron oxide black, propylene glycol and ammonium hydroxide. The imprinting ink of the 30 mg capsules contains shellac, propylene glycol, ammonia, potassium hydroxide, iron oxide black, and iron oxide yellow. The imprinting ink of the 60 mg capsules contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>50090-4723-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-4723-0) </PackageDescription>
<NDC11Code>50090-4723-00</NDC11Code>
<ProductNDC>50090-4723</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205101</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and opadry white (03F180003). Opadry white (03F180003) contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-5045-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-5045-0) </PackageDescription>
<NDC11Code>50090-5045-00</NDC11Code>
<ProductNDC>50090-5045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205101</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
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<NDC>
<NDCCode>50090-7208-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-7208-0) </PackageDescription>
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<ProductNDC>50090-7208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216798</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
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<StartMarketingDatePackage>20240805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white, crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer 407, polydextrose, polyethylene glycol, titanium dioxide, and triacetin. In addition, 54 mg individual tablets contain: D&C Yellow # 10 and FD&C Yellow # 6. Meets USP dissolution test 3.</Description>
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<NDC>
<NDCCode>50090-7209-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-7209-0) </PackageDescription>
<NDC11Code>50090-7209-00</NDC11Code>
<ProductNDC>50090-7209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216798</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
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<StartMarketingDatePackage>20240805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2).</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white, crystalline powder. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer 407, polydextrose, polyethylene glycol, titanium dioxide, and triacetin. In addition, 54 mg individual tablets contain: D&C Yellow # 10 and FD&C Yellow # 6. Meets USP dissolution test 3.</Description>
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