{
"NDC": [
{
"NDCCode": "68084-340-97",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68084-340-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-340-96)",
"NDC11Code": "68084-0340-97",
"ProductNDC": "68084-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076933",
"LabelerName": "American Health Packaging",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "68084-339-97",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68084-339-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-339-96)",
"NDC11Code": "68084-0339-97",
"ProductNDC": "68084-339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076933",
"LabelerName": "American Health Packaging",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "68084-341-97",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68084-341-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-341-96)",
"NDC11Code": "68084-0341-97",
"ProductNDC": "68084-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076933",
"LabelerName": "American Health Packaging",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "21695-340-72",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (21695-340-72)",
"NDC11Code": "21695-0340-72",
"ProductNDC": "21695-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoprofen",
"NonProprietaryName": "Ketoprofen",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "50",
"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": "Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.",
"Description": "Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze."
},
{
"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": "51285-131-97",
"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": "67645-340-02",
"PackageDescription": "5 BAG in 1 CARTON (67645-340-02) / 2.27 kg in 1 BAG (67645-340-01) ",
"NDC11Code": "67645-0340-02",
"ProductNDC": "67645-340",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "67645-340-04",
"PackageDescription": "1 BAG in 1 CARTON (67645-340-04) / 11.35 kg in 1 BAG (67645-340-03) ",
"NDC11Code": "67645-0340-04",
"ProductNDC": "67645-340",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2026-05-18",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "67645-340-06",
"PackageDescription": "25 BAG in 1 CARTON (67645-340-06) / .454 kg in 1 BAG (67645-340-05) ",
"NDC11Code": "67645-0340-06",
"ProductNDC": "67645-340",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "67645-340-08",
"PackageDescription": "1 BAG in 1 CARTON (67645-340-08) / .454 kg in 1 BAG (67645-340-07) ",
"NDC11Code": "67645-0340-08",
"ProductNDC": "67645-340",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "67645-340-10",
"PackageDescription": "3 BAG in 1 CARTON (67645-340-10) / 4.54 kg in 1 BAG (67645-340-09) ",
"NDC11Code": "67645-0340-10",
"ProductNDC": "67645-340",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Nouryon Chemicals, S.A. de C.V.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "75",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "03-NOV-97"
},
{
"NDCCode": "68084-536-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-536-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-536-11) ",
"NDC11Code": "68084-0536-01",
"ProductNDC": "68084-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140424",
"EndMarketingDate": "20271031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076274",
"LabelerName": "American Health Packaging",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140424",
"EndMarketingDatePackage": "20271031",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved \"APO\" on one side and \"CL 300\" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "68084-752-19",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (68084-752-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-18) ",
"NDC11Code": "68084-0752-19",
"ProductNDC": "68084-752",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076274",
"LabelerName": "American Health Packaging",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230712",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved \"APO\" on one side and \"CL 300\" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "68084-752-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-752-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-95) ",
"NDC11Code": "68084-0752-25",
"ProductNDC": "68084-752",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076274",
"LabelerName": "American Health Packaging",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140331",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved \"APO\" on one side and \"CL 300\" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "68084-995-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-995-25) > 1 TABLET in 1 BLISTER PACK (68084-995-95)",
"NDC11Code": "68084-0995-25",
"ProductNDC": "68084-995",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151210",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "American Health Packaging",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "97.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0009-0104-04",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0104-04) / 2 mL in 1 VIAL",
"NDC11Code": "00009-0104-04",
"ProductNDC": "0009-0104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincocin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20230818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050317",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230818",
"SamplePackage": "N",
"IndicationAndUsage": "LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "0009-0107-04",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0107-04) / 10 mL in 1 VIAL",
"NDC11Code": "00009-0107-04",
"ProductNDC": "0009-0107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincocin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "20230418",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050317",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230418",
"SamplePackage": "N",
"IndicationAndUsage": "LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "0009-0555-01",
"PackageDescription": "1 VIAL in 1 CARTON (0009-0555-01) / 2 mL in 1 VIAL",
"NDC11Code": "00009-0555-01",
"ProductNDC": "0009-0555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincocin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
"StartMarketingDate": "19641229",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050317",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19641229",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP)."
},
{
"NDCCode": "0065-0343-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0343-02",
"ProductNDC": "0065-0343",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0065-0349-04",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0349-04",
"ProductNDC": "0065-0349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0065-0349-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0349-05",
"ProductNDC": "0065-0349",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenylephrine Hydrochloride",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207926",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.",
"Description": "Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "0074-1017-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00074-1017-14",
"ProductNDC": "0074-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oriahnn",
"NonProprietaryName": "Elagolix And Estradiol And Norethisterone",
"DosageFormName": "KIT",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213388",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "Y",
"IndicationAndUsage": "ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].",
"Description": "ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water)."
},
{
"NDCCode": "0074-1017-56",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00074-1017-56",
"ProductNDC": "0074-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oriahnn",
"NonProprietaryName": "Elagolix And Estradiol And Norethisterone",
"DosageFormName": "KIT",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213388",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200529",
"SamplePackage": "N",
"IndicationAndUsage": "ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].",
"Description": "ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water)."
},
{
"NDCCode": "0093-3122-42",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28) ",
"NDC11Code": "00093-3122-42",
"ProductNDC": "0093-3122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jinteli",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076221",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 5",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110217",
"SamplePackage": "N",
"IndicationAndUsage": "Jinteli is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).",
"Description": "Jinteli® (norethindrone acetate and ethinyl estradiol tablets, USP) are a continuous dosage regimen of a progestin-estrogen combination for oral administration. Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one,7(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Each tablet also contains the following inactive ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. The structural formulas are as follows. Norethindrone Acetate, USP Ethinyl Estradiol, USP. C22H28O3 M.W. 340.46 C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0093-3122-98",
"PackageDescription": "90 TABLET in 1 BOTTLE (0093-3122-98) ",
"NDC11Code": "00093-3122-98",
"ProductNDC": "0093-3122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jinteli",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076221",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "NORETHINDRONE ACETATE; ETHINYL ESTRADIOL",
"StrengthNumber": "1; 5",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110217",
"SamplePackage": "N",
"IndicationAndUsage": "Jinteli is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).",
"Description": "Jinteli® (norethindrone acetate and ethinyl estradiol tablets, USP) are a continuous dosage regimen of a progestin-estrogen combination for oral administration. Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one,7(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Each tablet also contains the following inactive ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. The structural formulas are as follows. Norethindrone Acetate, USP Ethinyl Estradiol, USP. C22H28O3 M.W. 340.46 C20H24O2 M.W. 296.40."
},
{
"NDCCode": "0093-5455-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00093-5455-28",
"ProductNDC": "0093-5455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mimvey",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079193",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100602",
"SamplePackage": "N",
"IndicationAndUsage": "Mimvey is indicated for.",
"Description": "Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E2 is as follows. Estradiol, USP. C18H24O2, 1/2 H2O M.W. 281.4. Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows. Norethindrone Acetate, USP. C22H28O3 M.W. 340.5."
},
{
"NDCCode": "0093-5455-42",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00093-5455-42",
"ProductNDC": "0093-5455",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mimvey",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079193",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100602",
"SamplePackage": "N",
"IndicationAndUsage": "Mimvey is indicated for.",
"Description": "Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E2 is as follows. Estradiol, USP. C18H24O2, 1/2 H2O M.W. 281.4. Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows. Norethindrone Acetate, USP. C22H28O3 M.W. 340.5."
},
{
"NDCCode": "0187-1950-12",
"PackageDescription": "340 g in 1 JAR (0187-1950-12)",
"NDC11Code": "00187-1950-12",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1975-12",
"PackageDescription": "340 g in 1 JAR (0187-1975-12)",
"NDC11Code": "00187-1975-12",
"ProductNDC": "0187-1975",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave Itch Relief Moisturizing",
"ProprietaryNameSuffix": "Cream",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "VALEANT PHARMACEUTICALS NORTH AMERICA LLC",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0224-1901-91",
"PackageDescription": "340 g in 1 BAG (0224-1901-91) ",
"NDC11Code": "00224-1901-91",
"ProductNDC": "0224-1901",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konsyl Original Daily Fiber",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Konsyl Pharmaceuticals, Inc.",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "6",
"StrengthUnit": "g/6g",
"Status": "Deprecated",
"LastUpdate": "2022-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68084-340-97</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68084-340-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-340-96)</PackageDescription>
<NDC11Code>68084-0340-97</NDC11Code>
<ProductNDC>68084-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076933</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>68084-339-97</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68084-339-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-339-96)</PackageDescription>
<NDC11Code>68084-0339-97</NDC11Code>
<ProductNDC>68084-339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076933</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>68084-341-97</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68084-341-97) > 9 TABLET, COATED in 1 BLISTER PACK (68084-341-96)</PackageDescription>
<NDC11Code>68084-0341-97</NDC11Code>
<ProductNDC>68084-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076933</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-340-72</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (21695-340-72)</PackageDescription>
<NDC11Code>21695-0340-72</NDC11Code>
<ProductNDC>21695-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoprofen</ProprietaryName>
<NonProprietaryName>Ketoprofen</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>50</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>Carefully consider the potential benefits and risks of ketoprofen immediate-release capsules and ketoprofen extended-release capsules before deciding to use ketoprofen immediate-release capsules and ketoprofen extended-release capsules. Use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ketoprofen immediate-release capsules and ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Ketoprofen immediate-release capsules are indicated for the management of pain. Ketoprofen immediate-release capsules are also indicated for treatment of primary dysmenorrhea.</IndicationAndUsage>
<Description>Ketoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula. Its empirical formula is C16H14O3, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Each ketoprofen immediate-release capsule for oral administration contains 50 mg or 75 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. In addition, each of the empty gelatin capsules contains gelatin and titanium dioxide and the following colorant agents. 50 mg - D&C Yellow No. 10, FD&C Blue No.1 and FD&C Yellow No. 6. 75 mg - FD&C Blue No.1 and FD&C Green No. 3. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Each ketoprofen extended-release capsule for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sugar spheres, talc, triacetin and triethyl citrate. In addition, each of the empty gelatin capsules contains gelatin, sodium lauryl sulfate, and titanium dioxide and the following colorant agents. black iron oxideFD&C Blue No. 2 yellow iron oxide. The imprinting ink contains the following: black iron oxide, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.</Description>
</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>51285-131-97</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>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<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>67645-340-02</NDCCode>
<PackageDescription>5 BAG in 1 CARTON (67645-340-02) / 2.27 kg in 1 BAG (67645-340-01) </PackageDescription>
<NDC11Code>67645-0340-02</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67645-340-04</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (67645-340-04) / 11.35 kg in 1 BAG (67645-340-03) </PackageDescription>
<NDC11Code>67645-0340-04</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-18</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67645-340-06</NDCCode>
<PackageDescription>25 BAG in 1 CARTON (67645-340-06) / .454 kg in 1 BAG (67645-340-05) </PackageDescription>
<NDC11Code>67645-0340-06</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67645-340-08</NDCCode>
<PackageDescription>1 BAG in 1 CARTON (67645-340-08) / .454 kg in 1 BAG (67645-340-07) </PackageDescription>
<NDC11Code>67645-0340-08</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67645-340-10</NDCCode>
<PackageDescription>3 BAG in 1 CARTON (67645-340-10) / 4.54 kg in 1 BAG (67645-340-09) </PackageDescription>
<NDC11Code>67645-0340-10</NDC11Code>
<ProductNDC>67645-340</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Nouryon Chemicals, S.A. de C.V.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-NOV-97</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68084-536-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-536-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-536-11) </PackageDescription>
<NDC11Code>68084-0536-01</NDC11Code>
<ProductNDC>68084-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140424</StartMarketingDate>
<EndMarketingDate>20271031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076274</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140424</StartMarketingDatePackage>
<EndMarketingDatePackage>20271031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved "APO" on one side and "CL 300" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68084-752-19</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (68084-752-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-18) </PackageDescription>
<NDC11Code>68084-0752-19</NDC11Code>
<ProductNDC>68084-752</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076274</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved "APO" on one side and "CL 300" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68084-752-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-752-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-752-95) </PackageDescription>
<NDC11Code>68084-0752-25</NDC11Code>
<ProductNDC>68084-752</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076274</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y 12 platelet inhibitor indicated for: : 1 Acute coronary syndrome, 2 For patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1), 3 For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.1), 4 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel tablets, USP is a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4 H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16H 16ClNO 2SH 2SO 4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base. Clopidogrel tablets, USP 300 mg for oral administration are provided as pink, oblong, biconvex, film coated tablets engraved "APO" on one side and "CL 300" on the other side. The tablets contain 392 mg of clopidogrel bisulfate, which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains ferric oxide red, hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68084-995-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-995-25) > 1 TABLET in 1 BLISTER PACK (68084-995-95)</PackageDescription>
<NDC11Code>68084-0995-25</NDC11Code>
<ProductNDC>68084-995</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>97.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0009-0104-04</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0104-04) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0104-04</NDC11Code>
<ProductNDC>0009-0104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincocin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050317</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0009-0107-04</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0107-04) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0107-04</NDC11Code>
<ProductNDC>0009-0107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincocin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>20230418</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050317</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0009-0555-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0009-0555-01) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>00009-0555-01</NDC11Code>
<ProductNDC>0009-0555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincocin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL</RouteName>
<StartMarketingDate>19641229</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050317</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19641229</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>LINCOCIN (lincomycin injection, USP) is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18H34N2O6S.HCl.H2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. LINCOCIN contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. LINCOCIN is a sterile solution for intramuscular and intravenous use. LINCOCIN is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0065-0343-02</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0343-02) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0343-02</NDC11Code>
<ProductNDC>0065-0343</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-04</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-04) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-04</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0065-0349-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0065-0349-05) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00065-0349-05</NDC11Code>
<ProductNDC>0065-0349</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenylephrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207926</ApplicationNumber>
<LabelerName>Alcon Laboratories, Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.</IndicationAndUsage>
<Description>Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C9H13NO2.HCl. Molecular Weight: 203.67 g/mol. Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
</NDC>
<NDC>
<NDCCode>0074-1017-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-1017-14</NDC11Code>
<ProductNDC>0074-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oriahnn</ProprietaryName>
<NonProprietaryName>Elagolix And Estradiol And Norethisterone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213388</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).</Description>
</NDC>
<NDC>
<NDCCode>0074-1017-56</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-1017-56</NDC11Code>
<ProductNDC>0074-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oriahnn</ProprietaryName>
<NonProprietaryName>Elagolix And Estradiol And Norethisterone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213388</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).</Description>
</NDC>
<NDC>
<NDCCode>0093-3122-42</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28) </PackageDescription>
<NDC11Code>00093-3122-42</NDC11Code>
<ProductNDC>0093-3122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jinteli</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076221</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 5</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>2024-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jinteli is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
<Description>Jinteli® (norethindrone acetate and ethinyl estradiol tablets, USP) are a continuous dosage regimen of a progestin-estrogen combination for oral administration. Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one,7(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Each tablet also contains the following inactive ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. The structural formulas are as follows. Norethindrone Acetate, USP Ethinyl Estradiol, USP. C22H28O3 M.W. 340.46 C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0093-3122-98</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (0093-3122-98) </PackageDescription>
<NDC11Code>00093-3122-98</NDC11Code>
<ProductNDC>0093-3122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jinteli</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076221</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>NORETHINDRONE ACETATE; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>1; 5</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>2024-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Jinteli is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
<Description>Jinteli® (norethindrone acetate and ethinyl estradiol tablets, USP) are a continuous dosage regimen of a progestin-estrogen combination for oral administration. Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one,7(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Each tablet also contains the following inactive ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. The structural formulas are as follows. Norethindrone Acetate, USP Ethinyl Estradiol, USP. C22H28O3 M.W. 340.46 C20H24O2 M.W. 296.40.</Description>
</NDC>
<NDC>
<NDCCode>0093-5455-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-5455-28</NDC11Code>
<ProductNDC>0093-5455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mimvey</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079193</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mimvey is indicated for.</IndicationAndUsage>
<Description>Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E2 is as follows. Estradiol, USP. C18H24O2, 1/2 H2O M.W. 281.4. Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows. Norethindrone Acetate, USP. C22H28O3 M.W. 340.5.</Description>
</NDC>
<NDC>
<NDCCode>0093-5455-42</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00093-5455-42</NDC11Code>
<ProductNDC>0093-5455</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mimvey</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079193</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mimvey is indicated for.</IndicationAndUsage>
<Description>Mimvey® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E2 is as follows. Estradiol, USP. C18H24O2, 1/2 H2O M.W. 281.4. Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows. Norethindrone Acetate, USP. C22H28O3 M.W. 340.5.</Description>
</NDC>
<NDC>
<NDCCode>0187-1950-12</NDCCode>
<PackageDescription>340 g in 1 JAR (0187-1950-12)</PackageDescription>
<NDC11Code>00187-1950-12</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1975-12</NDCCode>
<PackageDescription>340 g in 1 JAR (0187-1975-12)</PackageDescription>
<NDC11Code>00187-1975-12</NDC11Code>
<ProductNDC>0187-1975</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave Itch Relief Moisturizing</ProprietaryName>
<ProprietaryNameSuffix>Cream</ProprietaryNameSuffix>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>VALEANT PHARMACEUTICALS NORTH AMERICA LLC</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0224-1901-91</NDCCode>
<PackageDescription>340 g in 1 BAG (0224-1901-91) </PackageDescription>
<NDC11Code>00224-1901-91</NDC11Code>
<ProductNDC>0224-1901</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Konsyl Original Daily Fiber</ProprietaryName>
<NonProprietaryName>Psyllium Husk</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Konsyl Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/6g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>