{
"NDC": [
{
"NDCCode": "51285-131-97",
"PackageDescription": "5 POUCH in 1 CARTON (51285-131-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0131-97",
"ProductNDC": "51285-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076380",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 20",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "51285-079-97",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (51285-079-97) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0079-97",
"ProductNDC": "51285-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin 1/20",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076380",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 20",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-082-97",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (51285-082-97) > 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0082-97",
"ProductNDC": "51285-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin 1.5/30",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076381",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1.5; 30",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-127-97",
"PackageDescription": "5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0127-97",
"ProductNDC": "51285-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "21 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076381",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1.5; 30",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "51285-040-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-040-01) ",
"NDC11Code": "51285-0040-01",
"ProductNDC": "51285-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "10; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-047-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51285-047-02) ",
"NDC11Code": "51285-0047-02",
"ProductNDC": "51285-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "2.5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-050-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51285-050-02) ",
"NDC11Code": "51285-0050-02",
"ProductNDC": "51285-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziac",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931026",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020186",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931026",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.",
"Description": "ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide."
},
{
"NDCCode": "51285-366-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-366-01) ",
"NDC11Code": "51285-0366-01",
"ProductNDC": "51285-366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trexall",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040385",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010503",
"SamplePackage": "N",
"IndicationAndUsage": "TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).",
"Description": "TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake."
},
{
"NDCCode": "51285-367-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01) ",
"NDC11Code": "51285-0367-01",
"ProductNDC": "51285-367",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trexall",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040385",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010503",
"SamplePackage": "N",
"IndicationAndUsage": "TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).",
"Description": "TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake."
},
{
"NDCCode": "51285-368-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-368-01) ",
"NDC11Code": "51285-0368-01",
"ProductNDC": "51285-368",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trexall",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040385",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010503",
"SamplePackage": "N",
"IndicationAndUsage": "TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).",
"Description": "TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake."
},
{
"NDCCode": "51285-369-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-369-01) ",
"NDC11Code": "51285-0369-01",
"ProductNDC": "51285-369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trexall",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040385",
"LabelerName": "Teva Women's Health LLC",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010503",
"SamplePackage": "N",
"IndicationAndUsage": "TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).",
"Description": "TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake."
},
{
"NDCCode": "54288-131-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (54288-131-10)",
"NDC11Code": "54288-0131-10",
"ProductNDC": "54288-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenoprofen Calcium",
"NonProprietaryName": "Fenoprofen Calcium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017604",
"LabelerName": "BPI Labs LLC",
"SubstanceName": "FENOPROFEN CALCIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FENOPROFEN CALCIUM is indicated for: 1 Relief of mild to moderate pain in adults., 2 Relief of the signs and symptoms of rheumatoid arthrites., 3 Relief of the signs and symptoms of osteoarthritis.",
"Description": "FENOPROFEN CALCIUM (fenoprofen calcium, USP) capsules is a nonsteroidal, anti-inflammatory drug available in 200 mg and 400 mg capsule form for oral administration. The 200 mg capsule is opaque yellow No. 97 cap and opaque white body, imprinted with “RX681” on the cap and body. The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg\" on the cap and “EP 123” on the body. The chemical name is Benzenaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C30H26CaO62H2O, and it has the following chemical structure. Fenoprofen Calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen calcium capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in Fenoprofen Calcium capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and red iron oxide, and the 400 mg capsules contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, and titanium dioxide."
},
{
"NDCCode": "51285-060-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-060-01)",
"NDC11Code": "51285-0060-01",
"ProductNDC": "51285-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zebeta",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019982",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "51285-061-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51285-061-01)",
"NDC11Code": "51285-0061-01",
"ProductNDC": "51285-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zebeta",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19931029",
"EndMarketingDate": "20170531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019982",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "51285-063-90",
"PackageDescription": "6 POUCH in 1 CARTON (51285-063-90) / 1 BLISTER PACK in 1 POUCH (51285-063-89) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0063-90",
"ProductNDC": "51285-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prefest",
"NonProprietaryName": "Estradiol/norgestimate",
"DosageFormName": "KIT",
"StartMarketingDate": "20060530",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076812",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060530",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "PREFEST is indicated in women who have a uterus for the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.",
"Description": "The PREFEST® regimen provides for a single oral tablet to be taken once daily. The peach tablet containing 1 mg estradiol, USP is taken on days one through three of therapy; the white tablet containing 1 mg estradiol, USP and 0.09 mg norgestimate, USP is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST. The estrogenic component of PREFEST is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The progestational component of PREFEST is micronized norgestimate, USP a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-. It has an empirical formula of C23H31NO3 and a molecular weight of 369.50. The structural formula is. Each tablet for oral administration contains 1 mg estradiol, USP alone or 1 mg estradiol, USP and 0.09 mg of norgestimate, USP. The inactive ingredients are as follows. The estradiol, USP tablet contains anhydrous lactose, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, magnesium stearate and microcrystalline cellulose. The estradiol and norgestimate tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "51285-080-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-080-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0080-70",
"ProductNDC": "51285-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1/20",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-081-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-081-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0081-98",
"ProductNDC": "51285-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1/20",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-083-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-083-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0083-70",
"ProductNDC": "51285-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1.5/30",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-084-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-084-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0084-98",
"ProductNDC": "51285-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin Fe 1.5/30",
"ProprietaryNameSuffix": "28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20081001",
"EndMarketingDate": "20151130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-12-04"
},
{
"NDCCode": "51285-087-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0087-87",
"ProductNDC": "51285-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Seasonique",
"NonProprietaryName": "Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20060710",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021840",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060710",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-092-87",
"PackageDescription": "2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0092-87",
"ProductNDC": "51285-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loseasonique",
"NonProprietaryName": "Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20090323",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022262",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090323",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "51285-100-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-100-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0100-88",
"ProductNDC": "51285-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Take Action",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140217",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140217",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "51285-103-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-103-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0103-88",
"ProductNDC": "51285-103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aftera",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141020",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141020",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "51285-114-58",
"PackageDescription": "6 POUCH in 1 CARTON (51285-114-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0114-58",
"ProductNDC": "51285-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mircette",
"NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20090924",
"EndMarketingDate": "20150731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075863",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2015-08-07"
},
{
"NDCCode": "51285-120-58",
"PackageDescription": "6 POUCH in 1 CARTON (51285-120-58) / 1 BLISTER PACK in 1 POUCH (51285-120-79) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0120-58",
"ProductNDC": "51285-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mircette",
"NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20140915",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075863",
"LabelerName": "Teva Women's Health LLC",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140915",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides.",
"Description": "Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Mircette also contains 5 yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, povidone, polysorbate 80, pregelatinized corn starch, stearic acid, titanium dioxide and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
},
{
"NDCCode": "51285-124-88",
"PackageDescription": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-124-88) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "51285-0124-88",
"ProductNDC": "51285-124",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plan B One-step",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131101",
"EndMarketingDate": "20170630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021998",
"LabelerName": "Teva Women's Health, Inc.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "51285-125-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-125-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0125-70",
"ProductNDC": "51285-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health LLC",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "51285-126-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-126-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0126-98",
"ProductNDC": "51285-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20150722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076081",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150722",
"SamplePackage": "N"
},
{
"NDCCode": "51285-128-70",
"PackageDescription": "5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0128-70",
"ProductNDC": "51285-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health LLC",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40."
},
{
"NDCCode": "51285-129-98",
"PackageDescription": "30 POUCH in 1 CARTON (51285-129-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "51285-0129-98",
"ProductNDC": "51285-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loestrin",
"ProprietaryNameSuffix": "Fe 28 Day",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20150729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076064",
"LabelerName": "Teva Women's Health, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150729",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>51285-131-97</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-131-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0131-97</NDC11Code>
<ProductNDC>51285-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076380</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 20</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>51285-079-97</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (51285-079-97) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0079-97</NDC11Code>
<ProductNDC>51285-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin 1/20</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076380</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 20</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-082-97</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (51285-082-97) > 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0082-97</NDC11Code>
<ProductNDC>51285-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076381</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1.5; 30</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-127-97</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0127-97</NDC11Code>
<ProductNDC>51285-127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>21 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076381</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1.5; 30</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>51285-040-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-040-01) </PackageDescription>
<NDC11Code>51285-0040-01</NDC11Code>
<ProductNDC>51285-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziac</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931026</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020186</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>10; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-047-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51285-047-02) </PackageDescription>
<NDC11Code>51285-0047-02</NDC11Code>
<ProductNDC>51285-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziac</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931026</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020186</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>2.5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-050-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51285-050-02) </PackageDescription>
<NDC11Code>51285-0050-02</NDC11Code>
<ProductNDC>51285-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziac</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931026</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020186</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931026</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIAC (bisoprolol fumarate and hydrochlorothiazide) is indicated in the management of hypertension.</IndicationAndUsage>
<Description>ZIAC® (bisoprolol fumarate and hydrochlorothiazide) is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each ZIAC®-2.5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………..2.5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-5 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate……………………………………………5 mg. Hydrochlorothiazide………………………………………..6.25 mg. Each ZIAC®-10 mg/6.25 mg tablet for oral administration contains. Bisoprolol fumarate…………………………………………...10 mg. Hydrochlorothiazide………………………………………..6.25 mg. Inactive ingredients include Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 10 mg/6.25mg tablet also contains Colloidal Silicon Dioxide. The 5 mg/6.25 mg tablet also contains Colloidal Silicon Dioxide, and Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Crospovidone, Pregelatinized Starch, and Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-366-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-366-01) </PackageDescription>
<NDC11Code>51285-0366-01</NDC11Code>
<ProductNDC>51285-366</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trexall</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040385</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
<Description>TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51285-367-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01) </PackageDescription>
<NDC11Code>51285-0367-01</NDC11Code>
<ProductNDC>51285-367</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trexall</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040385</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
<Description>TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51285-368-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-368-01) </PackageDescription>
<NDC11Code>51285-0368-01</NDC11Code>
<ProductNDC>51285-368</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trexall</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040385</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
<Description>TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51285-369-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-369-01) </PackageDescription>
<NDC11Code>51285-0369-01</NDC11Code>
<ProductNDC>51285-369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trexall</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040385</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TREXALL is a dihydrofolate reductase inhibitor indicated for the: 1 Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1), 2 Treatment of adults with mycosis fungoides (1.1), 3 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1), 4 Treatment of adults with rheumatoid arthritis (1.2), 5 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3), 6 Treatment of adults with severe psoriasis (1.4).</IndicationAndUsage>
<Description>TREXALL® (methotrexate tablets, USP) is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 and the molecular weight is 454.45 g/mol. The structural formula is. TREXALL (methotrexate tablets, USP) for oral use is available in bottles of 30 tablets. Each tablet contains 5 mg methotrexate, USP (equivalent to 5.48 mg methotrexate sodium), 7.5 mg methotrexate, USP (equivalent to 8.23 mg methotrexate sodium), 10 mg methotrexate, USP (equivalent to 10.97 mg methotrexate sodium), or 15 mg methotrexate, USP (equivalent to 16.45 mg methotrexate sodium). Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide. The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake. The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake. The 10 mg also contains: FD&C Red No. 40 Aluminum lake. The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>54288-131-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (54288-131-10)</PackageDescription>
<NDC11Code>54288-0131-10</NDC11Code>
<ProductNDC>54288-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenoprofen Calcium</ProprietaryName>
<NonProprietaryName>Fenoprofen Calcium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017604</ApplicationNumber>
<LabelerName>BPI Labs LLC</LabelerName>
<SubstanceName>FENOPROFEN CALCIUM</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FENOPROFEN CALCIUM is indicated for: 1 Relief of mild to moderate pain in adults., 2 Relief of the signs and symptoms of rheumatoid arthrites., 3 Relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>FENOPROFEN CALCIUM (fenoprofen calcium, USP) capsules is a nonsteroidal, anti-inflammatory drug available in 200 mg and 400 mg capsule form for oral administration. The 200 mg capsule is opaque yellow No. 97 cap and opaque white body, imprinted with “RX681” on the cap and body. The 400 mg capsule is opaque green cap and opaque blue body, imprinted with “NALFON 400 mg" on the cap and “EP 123” on the body. The chemical name is Benzenaecetic acid, α-methyl-3-phenoxy-, calcium salt dihydrate, (±)-. The molecular weight is 558.65. Its molecular formula is C30H26CaO62H2O, and it has the following chemical structure. Fenoprofen Calcium is an arylacetic acid derivative. It is a white crystalline powder. At 25°C, it dissolves to a 15 mg/mL solution in alcohol (95%). It is slightly soluble in water and insoluble in benzene.The pKa of fenoprofen calcium is 4.5 at 25°C. Fenoprofen calcium capsules contain fenoprofen calcium as the dihydrate in an amount equivalent to 200 mg (0.826 mmol) or 400 mg (1.65 mmol) of fenoprofen. Inactive ingredients in Fenoprofen Calcium capsules are crospovidone, magnesium stearate, sodium lauryl sulfate, and talc. In addition, the 200 mg capsules contain gelatin, titanium dioxide, yellow iron oxide, and red iron oxide, and the 400 mg capsules contain gelatin, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-060-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-060-01)</PackageDescription>
<NDC11Code>51285-0060-01</NDC11Code>
<ProductNDC>51285-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zebeta</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019982</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-061-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51285-061-01)</PackageDescription>
<NDC11Code>51285-0061-01</NDC11Code>
<ProductNDC>51285-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zebeta</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931029</StartMarketingDate>
<EndMarketingDate>20170531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019982</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-063-90</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-063-90) / 1 BLISTER PACK in 1 POUCH (51285-063-89) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0063-90</NDC11Code>
<ProductNDC>51285-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prefest</ProprietaryName>
<NonProprietaryName>Estradiol/norgestimate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060530</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076812</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060530</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREFEST is indicated in women who have a uterus for the: : 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.</IndicationAndUsage>
<Description>The PREFEST® regimen provides for a single oral tablet to be taken once daily. The peach tablet containing 1 mg estradiol, USP is taken on days one through three of therapy; the white tablet containing 1 mg estradiol, USP and 0.09 mg norgestimate, USP is taken on days four through six of therapy. This pattern is then repeated continuously to produce the constant estrogen/intermittent progestogen regimen of PREFEST. The estrogenic component of PREFEST is estradiol, USP. It is a white, crystalline solid, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The progestational component of PREFEST is micronized norgestimate, USP a white powder which is chemically described as 18,19-dinor-17-pregn-4-en-20-yn-3-one, 17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-. It has an empirical formula of C23H31NO3 and a molecular weight of 369.50. The structural formula is. Each tablet for oral administration contains 1 mg estradiol, USP alone or 1 mg estradiol, USP and 0.09 mg of norgestimate, USP. The inactive ingredients are as follows. The estradiol, USP tablet contains anhydrous lactose, croscarmellose sodium, FD&C yellow no. 6 aluminum lake, magnesium stearate and microcrystalline cellulose. The estradiol and norgestimate tablet contains anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>51285-080-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-080-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0080-70</NDC11Code>
<ProductNDC>51285-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1/20</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-081-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-081-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0081-98</NDC11Code>
<ProductNDC>51285-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1/20</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-083-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-083-70) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0083-70</NDC11Code>
<ProductNDC>51285-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-084-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-084-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0084-98</NDC11Code>
<ProductNDC>51285-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin Fe 1.5/30</ProprietaryName>
<ProprietaryNameSuffix>28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20081001</StartMarketingDate>
<EndMarketingDate>20151130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-12-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-087-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-087-87) / 1 BLISTER PACK in 1 POUCH (51285-087-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0087-87</NDC11Code>
<ProductNDC>51285-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Seasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel / Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20060710</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021840</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060710</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>SEASONIQUE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. The structural formulas for the active components are. Levonorgestrel. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light blue-green tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-092-87</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (51285-092-87) / 1 BLISTER PACK in 1 POUCH (51285-092-82) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0092-87</NDC11Code>
<ProductNDC>51285-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loseasonique</ProprietaryName>
<NonProprietaryName>Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090323</StartMarketingDate>
<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022262</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090323</StartMarketingDatePackage>
<EndMarketingDatePackage>20240430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOSEASONIQUE® is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>LOSEASONIQUE (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are. C21H28O2 MW: 312.4. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. C20H24O2 MW: 296.4. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51285-100-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-100-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0100-88</NDC11Code>
<ProductNDC>51285-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Take Action</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140217</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140217</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51285-103-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-103-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0103-88</NDC11Code>
<ProductNDC>51285-103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aftera</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141020</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141020</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51285-114-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-114-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0114-58</NDC11Code>
<ProductNDC>51285-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mircette</ProprietaryName>
<NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090924</StartMarketingDate>
<EndMarketingDate>20150731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075863</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2015-08-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-120-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (51285-120-58) / 1 BLISTER PACK in 1 POUCH (51285-120-79) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0120-58</NDC11Code>
<ProductNDC>51285-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mircette</ProprietaryName>
<NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140915</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075863</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides.</IndicationAndUsage>
<Description>Mircette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Mircette also contains 5 yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, polyethylene glycol, povidone, polysorbate 80, pregelatinized corn starch, stearic acid, titanium dioxide and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51285-124-88</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX, UNIT-DOSE (51285-124-88) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0124-88</NDC11Code>
<ProductNDC>51285-124</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plan B One-step</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<EndMarketingDate>20170630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021998</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>51285-125-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-125-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0125-70</NDC11Code>
<ProductNDC>51285-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>51285-126-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-126-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0126-98</NDC11Code>
<ProductNDC>51285-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076081</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51285-128-70</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51285-128-70) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0128-70</NDC11Code>
<ProductNDC>51285-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Loestrin 21 and Loestrin Fe 28 are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Loestrin® 21 and Loestrin® Fe 28 are progestogen-estrogen combinations. Loestrin® Fe 1/20 and 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP. C22H28O3 M.W. 340.46. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>51285-129-98</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (51285-129-98) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51285-0129-98</NDC11Code>
<ProductNDC>51285-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loestrin</ProprietaryName>
<ProprietaryNameSuffix>Fe 28 Day</ProprietaryNameSuffix>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076064</ApplicationNumber>
<LabelerName>Teva Women's Health, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>