{
"NDC": [
{
"NDCCode": "45963-460-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-460-03) ",
"NDC11Code": "45963-0460-03",
"ProductNDC": "45963-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130118",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "ACTAVIS PHARMA, INC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130118",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "45963-461-03",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-03) ",
"NDC11Code": "45963-0461-03",
"ProductNDC": "45963-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130118",
"EndMarketingDate": "20181231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "ACTAVIS PHARMA, INC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130118",
"EndMarketingDatePackage": "20181231",
"SamplePackage": "N"
},
{
"NDCCode": "45963-479-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (45963-479-03) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "45963-0479-03",
"ProductNDC": "45963-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021107",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150526",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron hydrochloride tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. Alosetron hydrochloride tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "45963-480-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "45963-0480-03",
"ProductNDC": "45963-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150526",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021107",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150526",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .",
"Description": "The active ingredient in alosetron hydrochloride tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. Alosetron hydrochloride tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine."
},
{
"NDCCode": "45963-600-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (45963-600-03) ",
"NDC11Code": "45963-0600-03",
"ProductNDC": "45963-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078371",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20131105",
"SamplePackage": "N"
},
{
"NDCCode": "30698-460-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (30698-460-03) ",
"NDC11Code": "30698-0460-03",
"ProductNDC": "30698-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopressor",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218698",
"LabelerName": "VALIDUS PHARMACEUTICALS LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"Description": "LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "49967-460-03",
"PackageDescription": "2 mL in 1 PACKET (49967-460-03) ",
"NDC11Code": "49967-0460-03",
"ProductNDC": "49967-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "La Roche Posay Laboratoire Dermatologique Anthelios Ha Mineral Broad Spectrum Spf 30 Daily Moisturizing Sunscreen",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2024-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201201",
"SamplePackage": "N",
"IndicationAndUsage": "- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "51316-460-06",
"PackageDescription": "1 KIT in 1 CARTON (51316-460-06) * 1 PATCH in 1 POUCH (51316-370-02) / 11 g in 1 PATCH * 1 PATCH in 1 POUCH (51316-370-03) / 23 g in 1 PATCH * 1 PATCH in 1 POUCH (51316-370-01) / 7 g in 1 PATCH",
"NDC11Code": "51316-0460-06",
"ProductNDC": "51316-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain-relieving Patch",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "CVS Pharmacy",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain."
},
{
"NDCCode": "59301-001-03",
"PackageDescription": "460 L in 1 CYLINDER (59301-001-03) ",
"NDC11Code": "59301-0001-03",
"ProductNDC": "59301-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110831",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Oxygen Support Systems Inc",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110831",
"SamplePackage": "N"
},
{
"NDCCode": "63304-460-03",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (63304-460-03)",
"NDC11Code": "63304-0460-03",
"ProductNDC": "63304-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloroquine Phosphate",
"NonProprietaryName": "Chloroquine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090610",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "CHLOROQUINE PHOSPHATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "66336-460-03",
"PackageDescription": "3 TABLET, FILM COATED in 1 BOTTLE (66336-460-03)",
"NDC11Code": "66336-0460-03",
"ProductNDC": "66336-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078616",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide; the 5-mg tablet also contains FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, polyethylene glycol, polyvinyl alcohol, and talc; the 10-mg tablet also contains stearic acid and triacetin."
},
{
"NDCCode": "68428-460-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-460-03) ",
"NDC11Code": "68428-0460-03",
"ProductNDC": "68428-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kousso",
"NonProprietaryName": "Hagenia Abyssinica Flower",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "HAGENIA ABYSSINICA FLOWER",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100315",
"SamplePackage": "N"
},
{
"NDCCode": "73763-460-03",
"PackageDescription": "946 mL in 1 BOTTLE, DISPENSING (73763-460-03) ",
"NDC11Code": "73763-0460-03",
"ProductNDC": "73763-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural House Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Aquagenics Technologies",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200316",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on skin."
},
{
"NDCCode": "76348-460-03",
"PackageDescription": "1 APPLICATOR in 1 BOX (76348-460-03) > 84 g in 1 APPLICATOR (76348-460-01) ",
"NDC11Code": "76348-0460-03",
"ProductNDC": "76348-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bouquet Cooling Formula",
"NonProprietaryName": "Menthol Roll-on",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191209",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Renu Laboratories, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "4.2",
"StrengthUnit": "g/84g",
"Status": "Deprecated",
"LastUpdate": "2022-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191209",
"SamplePackage": "N"
},
{
"NDCCode": "76591-601-03",
"PackageDescription": "460 g in 1 BAG (76591-601-03) ",
"NDC11Code": "76591-0601-03",
"ProductNDC": "76591-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Antiseptic Wipes",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200828",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Gotdya Fine Chemical Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200828",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "78506-010-03",
"PackageDescription": "460 g in 1 CONTAINER (78506-010-03) ",
"NDC11Code": "78506-0010-03",
"ProductNDC": "78506-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean Disinfectant Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Clean One Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".14",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizing wipes to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "84522-460-03",
"PackageDescription": "30 mL in 1 BOTTLE (84522-460-03) ",
"NDC11Code": "84522-0460-03",
"ProductNDC": "84522-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Pore Control Serum",
"NonProprietaryName": "Trstay Pore Control Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "45963-200-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-11)",
"NDC11Code": "45963-0200-11",
"ProductNDC": "45963-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160126",
"EndMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "45963-202-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-202-11)",
"NDC11Code": "45963-0202-11",
"ProductNDC": "45963-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151228",
"EndMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078458",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "45963-325-50",
"PackageDescription": "1 BOTTLE in 1 CARTON (45963-325-50) > 50 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "45963-0325-50",
"ProductNDC": "45963-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methoxsalen",
"NonProprietaryName": "Methoxsalen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202603",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "METHOXSALEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160914",
"SamplePackage": "N"
},
{
"NDCCode": "45963-418-06",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06) ",
"NDC11Code": "45963-0418-06",
"ProductNDC": "45963-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208862",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190528",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has a molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1,000 mg of ranolazine and the following inactive ingredients: black iron oxide, hypromellose 2910, magnesium stearate, methacrylic acid copolymer (Type C), microcrystalline cellulose, sodium hydroxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. The 1,000 mg tablets also contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "45963-418-50",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-50) ",
"NDC11Code": "45963-0418-50",
"ProductNDC": "45963-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208862",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190528",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "45963-461-96",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-96)",
"NDC11Code": "45963-0461-96",
"ProductNDC": "45963-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Actavis Inc",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-03-06",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "45963-565-08",
"PackageDescription": "90 TABLET in 1 BOTTLE (45963-565-08) ",
"NDC11Code": "45963-0565-08",
"ProductNDC": "45963-565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170426",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202968",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170426",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "45963-565-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (45963-565-30) ",
"NDC11Code": "45963-0565-30",
"ProductNDC": "45963-565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170426",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202968",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170426",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "45963-568-08",
"PackageDescription": "90 TABLET in 1 BOTTLE (45963-568-08) ",
"NDC11Code": "45963-0568-08",
"ProductNDC": "45963-568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170426",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202968",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170426",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "45963-568-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (45963-568-30) ",
"NDC11Code": "45963-0568-30",
"ProductNDC": "45963-568",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170426",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202968",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170426",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate."
},
{
"NDCCode": "45963-608-60",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (45963-608-60) > 100 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "45963-0608-60",
"ProductNDC": "45963-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epirubicin Hydrochloride",
"NonProprietaryName": "Epirubicin Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065445",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "EPIRUBICIN HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20111128",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "45963-611-53",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0611-53",
"ProductNDC": "45963-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078803",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .",
"Description": "Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively."
},
{
"NDCCode": "45963-611-59",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-59) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0611-59",
"ProductNDC": "45963-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150105",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078803",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150105",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .",
"Description": "Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively."
}
]
}
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<NDCList>
<NDC>
<NDCCode>45963-460-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-460-03) </PackageDescription>
<NDC11Code>45963-0460-03</NDC11Code>
<ProductNDC>45963-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>ACTAVIS PHARMA, INC.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130118</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-461-03</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-03) </PackageDescription>
<NDC11Code>45963-0461-03</NDC11Code>
<ProductNDC>45963-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130118</StartMarketingDate>
<EndMarketingDate>20181231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>ACTAVIS PHARMA, INC.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130118</StartMarketingDatePackage>
<EndMarketingDatePackage>20181231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-479-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45963-479-03) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>45963-0479-03</NDC11Code>
<ProductNDC>45963-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. Alosetron hydrochloride tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>45963-480-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45963-480-03) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>45963-0480-03</NDC11Code>
<ProductNDC>45963-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150526</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021107</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150526</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: : 1 chronic IBS symptoms (generally lasting 6 months or longer), , 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and , 3 not responded adequately to conventional therapy. .</IndicationAndUsage>
<Description>The active ingredient in alosetron hydrochloride tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17H 18N 4OHCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:. Alosetron hydrochloride tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.</Description>
</NDC>
<NDC>
<NDCCode>45963-600-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (45963-600-03) </PackageDescription>
<NDC11Code>45963-0600-03</NDC11Code>
<ProductNDC>45963-600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078371</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30698-460-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (30698-460-03) </PackageDescription>
<NDC11Code>30698-0460-03</NDC11Code>
<ProductNDC>30698-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopressor</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218698</ApplicationNumber>
<LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49967-460-03</NDCCode>
<PackageDescription>2 mL in 1 PACKET (49967-460-03) </PackageDescription>
<NDC11Code>49967-0460-03</NDC11Code>
<ProductNDC>49967-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>La Roche Posay Laboratoire Dermatologique Anthelios Ha Mineral Broad Spectrum Spf 30 Daily Moisturizing Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>- helps prevent sunburn. - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51316-460-06</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51316-460-06) * 1 PATCH in 1 POUCH (51316-370-02) / 11 g in 1 PATCH * 1 PATCH in 1 POUCH (51316-370-03) / 23 g in 1 PATCH * 1 PATCH in 1 POUCH (51316-370-01) / 7 g in 1 PATCH</PackageDescription>
<NDC11Code>51316-0460-06</NDC11Code>
<ProductNDC>51316-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain-relieving Patch</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59301-001-03</NDCCode>
<PackageDescription>460 L in 1 CYLINDER (59301-001-03) </PackageDescription>
<NDC11Code>59301-0001-03</NDC11Code>
<ProductNDC>59301-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110831</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Oxygen Support Systems Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63304-460-03</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (63304-460-03)</PackageDescription>
<NDC11Code>63304-0460-03</NDC11Code>
<ProductNDC>63304-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chloroquine Phosphate</ProprietaryName>
<NonProprietaryName>Chloroquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090610</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CHLOROQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66336-460-03</NDCCode>
<PackageDescription>3 TABLET, FILM COATED in 1 BOTTLE (66336-460-03)</PackageDescription>
<NDC11Code>66336-0460-03</NDC11Code>
<ProductNDC>66336-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078616</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide; the 5-mg tablet also contains FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, polyethylene glycol, polyvinyl alcohol, and talc; the 10-mg tablet also contains stearic acid and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>68428-460-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-460-03) </PackageDescription>
<NDC11Code>68428-0460-03</NDC11Code>
<ProductNDC>68428-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kousso</ProprietaryName>
<NonProprietaryName>Hagenia Abyssinica Flower</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100315</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>HAGENIA ABYSSINICA FLOWER</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73763-460-03</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, DISPENSING (73763-460-03) </PackageDescription>
<NDC11Code>73763-0460-03</NDC11Code>
<ProductNDC>73763-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural House Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Aquagenics Technologies</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76348-460-03</NDCCode>
<PackageDescription>1 APPLICATOR in 1 BOX (76348-460-03) > 84 g in 1 APPLICATOR (76348-460-01) </PackageDescription>
<NDC11Code>76348-0460-03</NDC11Code>
<ProductNDC>76348-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bouquet Cooling Formula</ProprietaryName>
<NonProprietaryName>Menthol Roll-on</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Renu Laboratories, Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>4.2</StrengthNumber>
<StrengthUnit>g/84g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76591-601-03</NDCCode>
<PackageDescription>460 g in 1 BAG (76591-601-03) </PackageDescription>
<NDC11Code>76591-0601-03</NDC11Code>
<ProductNDC>76591-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Antiseptic Wipes</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200828</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Gotdya Fine Chemical Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200828</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78506-010-03</NDCCode>
<PackageDescription>460 g in 1 CONTAINER (78506-010-03) </PackageDescription>
<NDC11Code>78506-0010-03</NDC11Code>
<ProductNDC>78506-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean Disinfectant Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Clean One Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.14</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizing wipes to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84522-460-03</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (84522-460-03) </PackageDescription>
<NDC11Code>84522-0460-03</NDC11Code>
<ProductNDC>84522-460</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Pore Control Serum</ProprietaryName>
<NonProprietaryName>Trstay Pore Control Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45963-200-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-200-11)</PackageDescription>
<NDC11Code>45963-0200-11</NDC11Code>
<ProductNDC>45963-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160126</StartMarketingDate>
<EndMarketingDate>20170928</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078458</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>45963-202-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-202-11)</PackageDescription>
<NDC11Code>45963-0202-11</NDC11Code>
<ProductNDC>45963-202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151228</StartMarketingDate>
<EndMarketingDate>20170928</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078458</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>45963-325-50</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45963-325-50) > 50 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>45963-0325-50</NDC11Code>
<ProductNDC>45963-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methoxsalen</ProprietaryName>
<NonProprietaryName>Methoxsalen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202603</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>METHOXSALEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-418-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-06) </PackageDescription>
<NDC11Code>45963-0418-06</NDC11Code>
<ProductNDC>45963-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208862</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has a molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1,000 mg of ranolazine and the following inactive ingredients: black iron oxide, hypromellose 2910, magnesium stearate, methacrylic acid copolymer (Type C), microcrystalline cellulose, sodium hydroxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. The 1,000 mg tablets also contain red iron oxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>45963-418-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-418-50) </PackageDescription>
<NDC11Code>45963-0418-50</NDC11Code>
<ProductNDC>45963-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208862</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190528</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-461-96</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45963-461-96)</PackageDescription>
<NDC11Code>45963-0461-96</NDC11Code>
<ProductNDC>45963-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Actavis Inc</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-06</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45963-565-08</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (45963-565-08) </PackageDescription>
<NDC11Code>45963-0565-08</NDC11Code>
<ProductNDC>45963-565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170426</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202968</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170426</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>45963-565-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (45963-565-30) </PackageDescription>
<NDC11Code>45963-0565-30</NDC11Code>
<ProductNDC>45963-565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170426</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202968</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170426</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>45963-568-08</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (45963-568-08) </PackageDescription>
<NDC11Code>45963-0568-08</NDC11Code>
<ProductNDC>45963-568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170426</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202968</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170426</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>45963-568-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (45963-568-30) </PackageDescription>
<NDC11Code>45963-0568-30</NDC11Code>
<ProductNDC>45963-568</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170426</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202968</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170426</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C):.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin, USP is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/10 mg), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/20 mg), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/40 mg), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid anhydrous, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
</NDC>
<NDC>
<NDCCode>45963-608-60</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (45963-608-60) > 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>45963-0608-60</NDC11Code>
<ProductNDC>45963-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epirubicin Hydrochloride</ProprietaryName>
<NonProprietaryName>Epirubicin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065445</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>EPIRUBICIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111128</StartMarketingDatePackage>
<EndMarketingDatePackage>20201031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45963-611-53</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>45963-0611-53</NDC11Code>
<ProductNDC>45963-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078803</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .</IndicationAndUsage>
<Description>Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.</Description>
</NDC>
<NDC>
<NDCCode>45963-611-59</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-59) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>45963-0611-59</NDC11Code>
<ProductNDC>45963-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078803</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .</IndicationAndUsage>
<Description>Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.</Description>
</NDC>
</NDCList>