{
"NDC": [
{
"NDCCode": "69097-600-33",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69097-600-33) > 2.5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "69097-0600-33",
"ProductNDC": "69097-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20210319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206087",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210319",
"SamplePackage": "N",
"IndicationAndUsage": "Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dande."
},
{
"NDCCode": "69097-276-33",
"PackageDescription": "2.5 mL in 1 BOTTLE, PLASTIC (69097-276-33) ",
"NDC11Code": "69097-0276-33",
"ProductNDC": "69097-276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride Ophthalmic Solution",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20171205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206087",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "OLOPATADINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171205",
"SamplePackage": "N"
},
{
"NDCCode": "0406-0935-33",
"PackageDescription": "600 kg in 1 SUPERSACK (0406-0935-33)",
"NDC11Code": "00406-0935-33",
"ProductNDC": "0406-0935",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130219",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "58133-600-33",
"PackageDescription": "98 mL in 1 TUBE (58133-600-33) ",
"NDC11Code": "58133-0600-33",
"ProductNDC": "58133-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Real Time Pain Relief Cream",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Cosmetic Specialty Labs, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1.25",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain associated with. : 1 arthritis, 2 simple backache, 3 muscle strains, 4 sprains, 5 bruises, 6 cramps."
},
{
"NDCCode": "65753-600-33",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (65753-600-33) ",
"NDC11Code": "65753-0600-33",
"ProductNDC": "65753-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coretex Sun X 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoreTex Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.4; 12; 4; 4.8",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N"
},
{
"NDCCode": "68391-160-33",
"PackageDescription": "600 TABLET, FILM COATED in 1 BOTTLE (68391-160-33) ",
"NDC11Code": "68391-0160-33",
"ProductNDC": "68391-160",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250820",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "BJWC (Berkley & Jensen / BJ's)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250820",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:, 2 runny nose, 3 sneezing, 4 itchy, watery eyes, 5 itching of the nose or throat, 6 temporarily relieves these symptoms due to the common cold:, 7 runny nose, 8 sneezing."
},
{
"NDCCode": "72937-600-33",
"PackageDescription": "93 g in 1 BOTTLE (72937-600-33) ",
"NDC11Code": "72937-0600-33",
"ProductNDC": "72937-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menthol, Camphor",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200922",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "SUNSET NOVELTIES, INC",
"SubstanceName": "CAMPHOR, (-)-; MENTHOL",
"StrengthNumber": "2; 6",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200922",
"SamplePackage": "N",
"IndicationAndUsage": "Aid for temporary local relief of minor pain in muscles or joints."
},
{
"NDCCode": "73905-001-33",
"PackageDescription": "600 mL in 1 BOTTLE (73905-001-33) ",
"NDC11Code": "73905-0001-33",
"ProductNDC": "73905-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200328",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200328",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "N"
},
{
"NDCCode": "73905-003-33",
"PackageDescription": "600 mL in 1 BOTTLE (73905-003-33) ",
"NDC11Code": "73905-0003-33",
"ProductNDC": "73905-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200328",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200328",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "N"
},
{
"NDCCode": "74401-600-33",
"PackageDescription": "300 mL in 1 BOTTLE, PUMP (74401-600-33) ",
"NDC11Code": "74401-0600-33",
"ProductNDC": "74401-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisturizing Foam Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Volu-Sol",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "69097-210-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69097-210-02) ",
"NDC11Code": "69097-0210-02",
"ProductNDC": "69097-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206894",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2021-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210330",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'‑monophosphate. Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, magnesium stearate, red iron oxide, sodium lauryl sulfate. The tablets are film-coated with a coating material opadry AMB 80W54485 pink containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide yellow, iron oxide red and opadry AMB 80W56843 brown containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide red. Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 µg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C."
},
{
"NDCCode": "69097-239-35",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69097-239-35) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69097-0239-35",
"ProductNDC": "69097-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077861",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20070118",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "69097-241-38",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69097-241-38) > 15 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69097-0241-38",
"ProductNDC": "69097-241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077861",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20070118",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "69097-242-41",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69097-242-41) > 45 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69097-0242-41",
"ProductNDC": "69097-242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077861",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "450",
"StrengthUnit": "mg/45mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20070118",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "69097-243-43",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69097-243-43) > 60 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69097-0243-43",
"ProductNDC": "69097-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboplatin",
"NonProprietaryName": "Carboplatin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077861",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "CARBOPLATIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/60mL",
"Pharm_Classes": "Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20070118",
"SamplePackage": "N",
"IndicationAndUsage": "Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.",
"Description": "Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide."
},
{
"NDCCode": "69097-244-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (69097-244-02) ",
"NDC11Code": "69097-0244-02",
"ProductNDC": "69097-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir 600 And 800 Mg",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206288",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "DARUNAVIR HYDRATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231129",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir hydrate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester hydrate. Its molecular formula is C27H37N3O7S 2.5H2O and its molecular weight is 592.67. Darunavir hydrate has the following structural formula. Darunavir hydrate is a white to off-white crystalline powder which is soluble in methanol and freely soluble in acetone and dimethylsulfoxide. Darunavir 600 mg tablets are available as beige, capsule-shaped, biconvex, film coated tablets for oral administration. Each 600 mg tablet contains darunavir hydrate equivalent to 600 mg of darunavir. Darunavir 800 mg tablets are available as white to off-white, capsule-shaped, biconvex, film coated tablets for oral administration. Each 800 mg tablet contains darunavir hydrate equivalent to 800 mg of darunavir. Each tablet also contains the inactive ingredients microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. The 800 mg tablet also contains povidone. The 600 mg tablets are film coated with OPADRY® II 85F570242 Beige, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablets are film coated with OPADRY® White 85F28751, contains, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All dosages for darunavir hydrate are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "69097-248-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (69097-248-03) ",
"NDC11Code": "69097-0248-03",
"ProductNDC": "69097-248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir 600 And 800 Mg",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206288",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "DARUNAVIR HYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231129",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir hydrate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester hydrate. Its molecular formula is C27H37N3O7S 2.5H2O and its molecular weight is 592.67. Darunavir hydrate has the following structural formula. Darunavir hydrate is a white to off-white crystalline powder which is soluble in methanol and freely soluble in acetone and dimethylsulfoxide. Darunavir 600 mg tablets are available as beige, capsule-shaped, biconvex, film coated tablets for oral administration. Each 600 mg tablet contains darunavir hydrate equivalent to 600 mg of darunavir. Darunavir 800 mg tablets are available as white to off-white, capsule-shaped, biconvex, film coated tablets for oral administration. Each 800 mg tablet contains darunavir hydrate equivalent to 800 mg of darunavir. Each tablet also contains the inactive ingredients microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. The 800 mg tablet also contains povidone. The 600 mg tablets are film coated with OPADRY® II 85F570242 Beige, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablets are film coated with OPADRY® White 85F28751, contains, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All dosages for darunavir hydrate are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "69097-301-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69097-301-02) ",
"NDC11Code": "69097-0301-02",
"ProductNDC": "69097-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204766",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz tablets are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5kg. (1).",
"Description": "Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz tablets, USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: Lactose monohydrate, croscarmellose sodium, povidone, anhydrous dibasic calcium phosphate, magnesium stearate. The film coating contains opadry yellow (consist of hypromellose, titanium dioxide, macrogol, iron oxide yellow)."
},
{
"NDCCode": "69097-362-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02) ",
"NDC11Code": "69097-0362-02",
"ProductNDC": "69097-362",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abacavir And Lamivudine",
"NonProprietaryName": "Abacavir And Lamivudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091144",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ABACAVIR SULFATE; LAMIVUDINE",
"StrengthNumber": "600; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170329",
"SamplePackage": "N",
"IndicationAndUsage": "Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1).",
"Description": "Abacavir and lamivudine tablets USP. Abacavir and lamivudine tablets USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR®) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets USP are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine, and the inactive ingredients microcrystalline cellulose, sodium starch glycolate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate. The tablets are coated with a film (Opadry orange 14B53805) that is made of hyperomellose 15CP, titanium dioxide, PEG 400, FD&C Yellow No 6, polysorbate 80. Abacavir Sulfate. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and is soluble in water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid and is soluble in water."
},
{
"NDCCode": "69097-811-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (69097-811-02) ",
"NDC11Code": "69097-0811-02",
"ProductNDC": "69097-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-811-07",
"PackageDescription": "100 TABLET in 1 BOTTLE (69097-811-07) ",
"NDC11Code": "69097-0811-07",
"ProductNDC": "69097-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-811-12",
"PackageDescription": "500 TABLET in 1 BOTTLE (69097-811-12) ",
"NDC11Code": "69097-0811-12",
"ProductNDC": "69097-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-812-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (69097-812-02) ",
"NDC11Code": "69097-0812-02",
"ProductNDC": "69097-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-812-07",
"PackageDescription": "100 TABLET in 1 BOTTLE (69097-812-07) ",
"NDC11Code": "69097-0812-07",
"ProductNDC": "69097-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-812-12",
"PackageDescription": "500 TABLET in 1 BOTTLE (69097-812-12) ",
"NDC11Code": "69097-0812-12",
"ProductNDC": "69097-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202764",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).",
"Description": "The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla."
},
{
"NDCCode": "69097-821-03",
"PackageDescription": "60 TABLET in 1 BOTTLE (69097-821-03) ",
"NDC11Code": "69097-0821-03",
"ProductNDC": "69097-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077836",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161013",
"SamplePackage": "N",
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250820</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>BJWC (Berkley & Jensen / BJ's)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:, 2 runny nose, 3 sneezing, 4 itchy, watery eyes, 5 itching of the nose or throat, 6 temporarily relieves these symptoms due to the common cold:, 7 runny nose, 8 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72937-600-33</NDCCode>
<PackageDescription>93 g in 1 BOTTLE (72937-600-33) </PackageDescription>
<NDC11Code>72937-0600-33</NDC11Code>
<ProductNDC>72937-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menthol, Camphor</ProprietaryName>
<NonProprietaryName>Menthol, Camphor</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200922</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>SUNSET NOVELTIES, INC</LabelerName>
<SubstanceName>CAMPHOR, (-)-; MENTHOL</SubstanceName>
<StrengthNumber>2; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aid for temporary local relief of minor pain in muscles or joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73905-001-33</NDCCode>
<PackageDescription>600 mL in 1 BOTTLE (73905-001-33) </PackageDescription>
<NDC11Code>73905-0001-33</NDC11Code>
<ProductNDC>73905-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200328</StartMarketingDate>
<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200328</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73905-003-33</NDCCode>
<PackageDescription>600 mL in 1 BOTTLE (73905-003-33) </PackageDescription>
<NDC11Code>73905-0003-33</NDC11Code>
<ProductNDC>73905-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200328</StartMarketingDate>
<EndMarketingDate>20240423</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200328</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74401-600-33</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE, PUMP (74401-600-33) </PackageDescription>
<NDC11Code>74401-0600-33</NDC11Code>
<ProductNDC>74401-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisturizing Foam Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Volu-Sol</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-210-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69097-210-02) </PackageDescription>
<NDC11Code>69097-0210-02</NDC11Code>
<ProductNDC>69097-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206894</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablet is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'‑monophosphate. Efavirenz, Emtricitabine and Tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: Croscarmellose sodium, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, magnesium stearate, red iron oxide, sodium lauryl sulfate. The tablets are film-coated with a coating material opadry AMB 80W54485 pink containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide yellow, iron oxide red and opadry AMB 80W56843 brown containing polyvinyl alcohol-part, hydrolyzed, titanium dioxide, talc, lecithin (soya), xanthan gum, iron oxide red. Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (less than 10 µg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2R,5S)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula. Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. TDF is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>69097-239-35</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69097-239-35) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69097-0239-35</NDC11Code>
<ProductNDC>69097-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077861</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>69097-241-38</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69097-241-38) > 15 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69097-0241-38</NDC11Code>
<ProductNDC>69097-241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077861</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>69097-242-41</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69097-242-41) > 45 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69097-0242-41</NDC11Code>
<ProductNDC>69097-242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077861</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/45mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>69097-243-43</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69097-243-43) > 60 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69097-0243-43</NDC11Code>
<ProductNDC>69097-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboplatin</ProprietaryName>
<NonProprietaryName>Carboplatin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077861</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>CARBOPLATIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/60mL</StrengthUnit>
<Pharm_Classes>Platinum-containing Compounds [EXT],Platinum-based Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES). There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (≥ 3 years) because of the small number of patients with these outcomes: the small number of patients with residual tumor < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.</IndicationAndUsage>
<Description>Carboplatin injection is supplied as a sterile, pyrogen-free, 10 mg/mL aqueous solution of carboplatin, USP. It is available in multiuse vials containing 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL of carboplatin, USP. Inactive ingredients include water for injection, USP. The pH of the solution ranges from 5.0 to 7.0. Carboplatin, USP is a platinum coordination compound. The chemical name for carboplatin, USP is platinum, diammine [1, 1- cyclobutanedicarboxylato (2- )-0, 0']-, (SP- 4-2), and carboplatin, USP has the following structural formula. Carboplatin, USP is a crystalline powder. It is soluble in water at a rate of approximately 14 mg/mL, and the pH of a 1% solution is 5 to 7. It is virtually insoluble in ethanol, acetone, and dimethylacetamide.</Description>
</NDC>
<NDC>
<NDCCode>69097-244-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69097-244-02) </PackageDescription>
<NDC11Code>69097-0244-02</NDC11Code>
<ProductNDC>69097-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir 600 And 800 Mg</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206288</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>DARUNAVIR HYDRATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir hydrate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester hydrate. Its molecular formula is C27H37N3O7S 2.5H2O and its molecular weight is 592.67. Darunavir hydrate has the following structural formula. Darunavir hydrate is a white to off-white crystalline powder which is soluble in methanol and freely soluble in acetone and dimethylsulfoxide. Darunavir 600 mg tablets are available as beige, capsule-shaped, biconvex, film coated tablets for oral administration. Each 600 mg tablet contains darunavir hydrate equivalent to 600 mg of darunavir. Darunavir 800 mg tablets are available as white to off-white, capsule-shaped, biconvex, film coated tablets for oral administration. Each 800 mg tablet contains darunavir hydrate equivalent to 800 mg of darunavir. Each tablet also contains the inactive ingredients microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. The 800 mg tablet also contains povidone. The 600 mg tablets are film coated with OPADRY® II 85F570242 Beige, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablets are film coated with OPADRY® White 85F28751, contains, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All dosages for darunavir hydrate are expressed in terms of the free form of darunavir.</Description>
</NDC>
<NDC>
<NDCCode>69097-248-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69097-248-03) </PackageDescription>
<NDC11Code>69097-0248-03</NDC11Code>
<ProductNDC>69097-248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir 600 And 800 Mg</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206288</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>DARUNAVIR HYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir hydrate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester hydrate. Its molecular formula is C27H37N3O7S 2.5H2O and its molecular weight is 592.67. Darunavir hydrate has the following structural formula. Darunavir hydrate is a white to off-white crystalline powder which is soluble in methanol and freely soluble in acetone and dimethylsulfoxide. Darunavir 600 mg tablets are available as beige, capsule-shaped, biconvex, film coated tablets for oral administration. Each 600 mg tablet contains darunavir hydrate equivalent to 600 mg of darunavir. Darunavir 800 mg tablets are available as white to off-white, capsule-shaped, biconvex, film coated tablets for oral administration. Each 800 mg tablet contains darunavir hydrate equivalent to 800 mg of darunavir. Each tablet also contains the inactive ingredients microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. The 800 mg tablet also contains povidone. The 600 mg tablets are film coated with OPADRY® II 85F570242 Beige, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablets are film coated with OPADRY® White 85F28751, contains, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All dosages for darunavir hydrate are expressed in terms of the free form of darunavir.</Description>
</NDC>
<NDC>
<NDCCode>69097-301-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69097-301-02) </PackageDescription>
<NDC11Code>69097-0301-02</NDC11Code>
<ProductNDC>69097-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204766</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz tablets are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5kg. (1).</IndicationAndUsage>
<Description>Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is. Efavirenz is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz tablets, USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: Lactose monohydrate, croscarmellose sodium, povidone, anhydrous dibasic calcium phosphate, magnesium stearate. The film coating contains opadry yellow (consist of hypromellose, titanium dioxide, macrogol, iron oxide yellow).</Description>
</NDC>
<NDC>
<NDCCode>69097-362-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02) </PackageDescription>
<NDC11Code>69097-0362-02</NDC11Code>
<ProductNDC>69097-362</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abacavir And Lamivudine</ProprietaryName>
<NonProprietaryName>Abacavir And Lamivudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091144</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ABACAVIR SULFATE; LAMIVUDINE</SubstanceName>
<StrengthNumber>600; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1).</IndicationAndUsage>
<Description>Abacavir and lamivudine tablets USP. Abacavir and lamivudine tablets USP contain the following 2 synthetic nucleoside analogues: abacavir (ZIAGEN, also a component of TRIZIVIR®) and lamivudine (also known as EPIVIR or 3TC) with inhibitory activity against HIV-1. Abacavir and lamivudine tablets USP are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine, and the inactive ingredients microcrystalline cellulose, sodium starch glycolate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate. The tablets are coated with a film (Opadry orange 14B53805) that is made of hyperomellose 15CP, titanium dioxide, PEG 400, FD&C Yellow No 6, polysorbate 80. Abacavir Sulfate. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2H2SO4 and a molecular weight of 670.76 g per mol. It has the following structural formula. Abacavir sulfate is a white to off-white solid and is soluble in water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. Lamivudine. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine is a white to off-white crystalline solid and is soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>69097-811-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69097-811-02) </PackageDescription>
<NDC11Code>69097-0811-02</NDC11Code>
<ProductNDC>69097-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-811-07</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69097-811-07) </PackageDescription>
<NDC11Code>69097-0811-07</NDC11Code>
<ProductNDC>69097-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-811-12</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69097-811-12) </PackageDescription>
<NDC11Code>69097-0811-12</NDC11Code>
<ProductNDC>69097-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-812-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69097-812-02) </PackageDescription>
<NDC11Code>69097-0812-02</NDC11Code>
<ProductNDC>69097-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-812-07</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69097-812-07) </PackageDescription>
<NDC11Code>69097-0812-07</NDC11Code>
<ProductNDC>69097-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-812-12</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69097-812-12) </PackageDescription>
<NDC11Code>69097-0812-12</NDC11Code>
<ProductNDC>69097-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202764</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults (1), 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1).</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin USP is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and Aquarius® BP18114 Cool Vanilla.</Description>
</NDC>
<NDC>
<NDCCode>69097-821-03</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69097-821-03) </PackageDescription>
<NDC11Code>69097-0821-03</NDC11Code>
<ProductNDC>69097-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077836</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for:. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
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<IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for:. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
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<IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for:. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
<Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
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<Description>Duloxetine delayed-release capsules USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)- 2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS·HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include gelatin, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 mg capsules also contain FD & C Blue 2 and Iron Oxide Yellow and 60 mg capsules contain FD & C Blue 2. The 20 mg, 30 mg and 60 mg capsules are imprinted with black and grey ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.</Description>
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<Description>Duloxetine delayed-release capsules USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)- 2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS·HCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include gelatin, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 mg capsules also contain FD & C Blue 2 and Iron Oxide Yellow and 60 mg capsules contain FD & C Blue 2. The 20 mg, 30 mg and 60 mg capsules are imprinted with black and grey ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.</Description>
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