{
"NDC": [
{
"NDCCode": "55505-196-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-40",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-191-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-191-40) > 200 mL in 1 BOTTLE",
"NDC11Code": "55505-0191-40",
"ProductNDC": "55505-191",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190107",
"EndMarketingDate": "20210801",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190107",
"EndMarketingDatePackage": "20210801",
"SamplePackage": "N"
},
{
"NDCCode": "55505-192-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-192-40) / 200 mL in 1 BOTTLE",
"NDC11Code": "55505-0192-40",
"ProductNDC": "55505-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N"
},
{
"NDCCode": "61919-196-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (61919-196-40) ",
"NDC11Code": "61919-0196-40",
"ProductNDC": "61919-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091283",
"LabelerName": "TIZANIDINE HYDROCHLORIDE",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablet is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).",
"Description": "Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine's molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP are supplied as 2 and 4 mg tablets for oral administration. Tizanidine tablets USP are composed of the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose and anhydrous lactose."
},
{
"NDCCode": "69423-196-40",
"PackageDescription": "400 mL in 1 BOTTLE, PLASTIC (69423-196-40) ",
"NDC11Code": "69423-0196-40",
"ProductNDC": "69423-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Head And Shoulders Tea Tree 2in1",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171201",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171201",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "70108-387-01",
"PackageDescription": "1 KIT in 1 BOX (70108-387-01) * 40 mL in 1 BOTTLE, SPRAY (70108-197-01) * 40 mL in 1 BOTTLE, SPRAY (70108-202-01) * 40 mL in 1 BOTTLE, SPRAY (70108-203-01) * 40 mL in 1 BOTTLE, SPRAY (70108-196-01) ",
"NDC11Code": "70108-0387-01",
"ProductNDC": "70108-387",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care 4 Hand Sanitizers 1.35 Fl Oz (cucumber Melon, Coconut Breeze, Sweet Citrus, Calming Lavender)",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260903",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Ashtel Studios, Inc.",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260903",
"SamplePackage": "N"
},
{
"NDCCode": "55505-196-33",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-33",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-47",
"PackageDescription": "4 mL in 1 PACKET (55505-196-47) ",
"NDC11Code": "55505-0196-47",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-57",
"PackageDescription": "2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-57",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230429",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-64",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-196-64) / 325 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-64",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-65",
"PackageDescription": "1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON",
"NDC11Code": "55505-0196-65",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220616",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-68",
"PackageDescription": "3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-68",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221015",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-72",
"PackageDescription": "2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-72",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-84",
"PackageDescription": "2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-84",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "55505-196-85",
"PackageDescription": "1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE",
"NDC11Code": "55505-0196-85",
"ProductNDC": "55505-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nizoral",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220616",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020310",
"LabelerName": "Kramer Laboratories",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260112",
"SamplePackage": "N",
"IndicationAndUsage": "Uses controls flaking, scaling and itching associated with dandruff."
},
{
"NDCCode": "0703-3671-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00703-3671-01",
"ProductNDC": "0703-3671",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20120731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040843",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180608",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).",
"Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
},
{
"NDCCode": "0703-3675-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3675-01) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00703-3675-01",
"ProductNDC": "0703-3675",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040843",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120801",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).",
"Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
},
{
"NDCCode": "0703-3678-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-01) / 40 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00703-3678-01",
"ProductNDC": "0703-3678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040843",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120801",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).",
"Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
},
{
"NDCCode": "0703-3678-81",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3678-81) > 40 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00703-3678-81",
"ProductNDC": "0703-3678",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methotrexate",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS",
"StartMarketingDate": "20151214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040843",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151214",
"SamplePackage": "N",
"IndicationAndUsage": "Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the:Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7) Treatment of adults with rheumatoid arthritis (RA). (1.8)Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)Treatment of adults with severe psoriasis. (1.10).",
"Description": "Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.45. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5."
},
{
"NDCCode": "0904-6440-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-6440-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-6440-61",
"ProductNDC": "0904-6440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150514",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "42708-196-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42708-196-30) ",
"NDC11Code": "42708-0196-30",
"ProductNDC": "42708-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090694",
"LabelerName": "QPharma, Inc.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260410",
"SamplePackage": "Y",
"IndicationAndUsage": "Duloxetine delayed-release capsule is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults ( 1) , 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1) , 3 Diabetic peripheral neuropathic Pain (DPNP) in adults ( 1) , 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1) , 5 Chronic musculoskeletal pain in adults ( 1) .",
"Description": "Duloxetine delayed-release capsules, USP are selective serotonin and norepinephrine reuptake inhibitor SNRI for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol. Each capsule contains enteric-coated mini tablets of 20, 30, 40, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, FD & C Blue 2, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "43353-742-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-60)",
"NDC11Code": "43353-0742-60",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-742-80",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-80)",
"NDC11Code": "43353-0742-80",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-742-92",
"PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-92)",
"NDC11Code": "43353-0742-92",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-742-94",
"PackageDescription": "360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-94)",
"NDC11Code": "43353-0742-94",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-742-96",
"PackageDescription": "450 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-96)",
"NDC11Code": "43353-0742-96",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-742-98",
"PackageDescription": "540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-98)",
"NDC11Code": "43353-0742-98",
"ProductNDC": "43353-742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-756-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-756-60)",
"NDC11Code": "43353-0756-60",
"ProductNDC": "43353-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43353-756-80",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-756-80)",
"NDC11Code": "43353-0756-80",
"ProductNDC": "43353-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
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"NDC11Code": "43353-0756-92",
"ProductNDC": "43353-756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
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"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
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}
]
}
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<PackageDescription>1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-40</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
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<PackageDescription>1 BOTTLE in 1 CARTON (55505-191-40) > 200 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0191-40</NDC11Code>
<ProductNDC>55505-191</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
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<EndMarketingDate>20210801</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>55505-0192-40</NDC11Code>
<ProductNDC>55505-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
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<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>61919-196-40</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (61919-196-40) </PackageDescription>
<NDC11Code>61919-0196-40</NDC11Code>
<ProductNDC>61919-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091283</ApplicationNumber>
<LabelerName>TIZANIDINE HYDROCHLORIDE</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablet is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a centrally acting α2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine's molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP are supplied as 2 and 4 mg tablets for oral administration. Tizanidine tablets USP are composed of the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose and anhydrous lactose.</Description>
</NDC>
<NDC>
<NDCCode>69423-196-40</NDCCode>
<PackageDescription>400 mL in 1 BOTTLE, PLASTIC (69423-196-40) </PackageDescription>
<NDC11Code>69423-0196-40</NDC11Code>
<ProductNDC>69423-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Head And Shoulders Tea Tree 2in1</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70108-387-01</NDCCode>
<PackageDescription>1 KIT in 1 BOX (70108-387-01) * 40 mL in 1 BOTTLE, SPRAY (70108-197-01) * 40 mL in 1 BOTTLE, SPRAY (70108-202-01) * 40 mL in 1 BOTTLE, SPRAY (70108-203-01) * 40 mL in 1 BOTTLE, SPRAY (70108-196-01) </PackageDescription>
<NDC11Code>70108-0387-01</NDC11Code>
<ProductNDC>70108-387</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care 4 Hand Sanitizers 1.35 Fl Oz (cucumber Melon, Coconut Breeze, Sweet Citrus, Calming Lavender)</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260903</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Ashtel Studios, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55505-196-33</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-33</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
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<NDC11Code>55505-0196-47</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-57</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-57</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-64</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55505-196-64) / 325 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-64</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-65</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON</PackageDescription>
<NDC11Code>55505-0196-65</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-68</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-68</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-72</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-72</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-84</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-84</NDC11Code>
<ProductNDC>55505-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nizoral</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220616</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020310</ApplicationNumber>
<LabelerName>Kramer Laboratories</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55505-196-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55505-0196-85</NDC11Code>
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<LastUpdate>2026-09-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses controls flaking, scaling and itching associated with dandruff.</IndicationAndUsage>
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<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3671-01) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20120731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040843</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2025-09-26</LastUpdate>
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<IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
<Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
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<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0703-3675-01) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
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<ProductNDC>0703-3675</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methotrexate</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040843</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
<Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
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<ProductNDC>0703-3678</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040843</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma. (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen. (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. (1.7), 2 Treatment of adults with rheumatoid arthritis (RA). (1.8), 3 Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9), 4 Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
<Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.44. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 50 mg/2 mL, 250 mg/10 mL, and 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate, USP equivalent to 54.8 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 9.8 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 2 Each 25 mg/mL, 10 mL vial contains 250 mg methotrexate, USP equivalent to 274.2 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 49 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5., 3 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS</RouteName>
<StartMarketingDate>20151214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040843</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methotrexate Injection is a folate analog metabolic inhibitor indicated for: 1 The following neoplastic diseases for the:Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)Treatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3) Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)Treatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7) Treatment of adults with rheumatoid arthritis (RA). (1.8)Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)Treatment of adults with severe psoriasis. (1.10).</IndicationAndUsage>
<Description>Methotrexate, USP (formerly Amethopterin) is a folate analog metabolic inhibitor used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid. The structural formula is. C20H22N8O5 M.W. 454.45. Preservative-free Methotrexate Injection, USP is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use. Methotrexate Injection, USP, Isotonic Liquid, Preservative Free is available in 1 gram/40 mL single-dose vials. : 1 Each 25 mg/mL, 40 mL vial contains 1,000 mg methotrexate, USP equivalent to 1,096.7 mg of methotrexate sodium, and the following inactive ingredients: sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5.</Description>
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<NDC>
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<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-6440-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-6440-61</NDC11Code>
<ProductNDC>0904-6440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42708-196-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42708-196-30) </PackageDescription>
<NDC11Code>42708-0196-30</NDC11Code>
<ProductNDC>42708-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090694</ApplicationNumber>
<LabelerName>QPharma, Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260410</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsule is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: 1 Major depressive disorder (MDD) in adults ( 1) , 2 Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1) , 3 Diabetic peripheral neuropathic Pain (DPNP) in adults ( 1) , 4 Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1) , 5 Chronic musculoskeletal pain in adults ( 1) .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are selective serotonin and norepinephrine reuptake inhibitor SNRI for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol. Each capsule contains enteric-coated mini tablets of 20, 30, 40, or 60 mg of duloxetine (equivalent to 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, FD & C Blue 2, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.</Description>
</NDC>
<NDC>
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<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-60)</PackageDescription>
<NDC11Code>43353-0742-60</NDC11Code>
<ProductNDC>43353-742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
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<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-80)</PackageDescription>
<NDC11Code>43353-0742-80</NDC11Code>
<ProductNDC>43353-742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-742-92</NDCCode>
<PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-742-92)</PackageDescription>
<NDC11Code>43353-0742-92</NDC11Code>
<ProductNDC>43353-742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<LastUpdate>2020-01-01</LastUpdate>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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