{
"NDC": [
{
"NDCCode": "64764-253-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-253-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0253-06",
"ProductNDC": "64764-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-253-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (64764-253-03) ",
"NDC11Code": "64764-0253-03",
"ProductNDC": "64764-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130125",
"SamplePackage": "N",
"IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
},
{
"NDCCode": "64764-253-04",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (64764-253-04) ",
"NDC11Code": "64764-0253-04",
"ProductNDC": "64764-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130125",
"SamplePackage": "N",
"IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
},
{
"NDCCode": "64764-253-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05) ",
"NDC11Code": "64764-0253-05",
"ProductNDC": "64764-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130125",
"SamplePackage": "N",
"IndicationAndUsage": "OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "OSENI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes mellitus: alogliptin and pioglitazone."
},
{
"NDCCode": "11383-253-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (11383-253-06) > 177 mL in 1 BOTTLE",
"NDC11Code": "11383-0253-06",
"ProductNDC": "11383-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lice Killing",
"NonProprietaryName": "Piperonyl Butoxide, Pyrethrum Extract",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358G",
"LabelerName": "Weeks & Leo Co., Inc.",
"SubstanceName": "PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT",
"StrengthNumber": "4; .33",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2017-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121011",
"SamplePackage": "N",
"IndicationAndUsage": "treats head, pubic (crab), and body lice."
},
{
"NDCCode": "13537-253-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (13537-253-06) > 4.5 mL in 1 BOTTLE, PLASTIC (13537-253-05)",
"NDC11Code": "13537-0253-06",
"ProductNDC": "13537-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
"ProprietaryNameSuffix": "(obscure 8b) - Brown",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-253-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (14783-253-06) > 4.5 mL in 1 BOTTLE, PLASTIC (14783-253-05)",
"NDC11Code": "14783-0253-06",
"ProductNDC": "14783-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Natural Finish Moisturizing Foundation Spf 25",
"ProprietaryNameSuffix": "(obscure 8b) - Brown",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".065; .016",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "55301-253-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55301-253-06) > 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55301-0253-06",
"ProductNDC": "55301-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Pain Reliever Pm",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940515",
"EndMarketingDate": "20180310",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-03-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "59088-062-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-062-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)",
"NDC11Code": "59088-0062-00",
"ProductNDC": "59088-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Inflammatral Pak",
"NonProprietaryName": "Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-03-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65162-253-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (65162-253-06) ",
"NDC11Code": "65162-0253-06",
"ProductNDC": "65162-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077824",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091216",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine Tablets are indicated in. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets 150 mg twice daily. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.",
"Description": "The active ingredient in Ranitidine Tablets USP, 150 mg and Ranitidine Tablets USP, 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The empirical formula is C13H22N4O3S·HCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each Ranitidine Tablet USP, 150 mg for oral administration contains 167.4 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, triethyl citrate and FD&C Yellow #6."
},
{
"NDCCode": "66277-253-06",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 BOX (66277-253-06) > 5 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC",
"NDC11Code": "66277-0253-06",
"ProductNDC": "66277-253",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"StartMarketingDate": "20110831",
"MarketingCategoryName": "EXPORT ONLY",
"LabelerName": "Galephar Pharmaceutical Research Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "68428-253-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-253-06) ",
"NDC11Code": "68428-0253-06",
"ProductNDC": "68428-253",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzinum",
"NonProprietaryName": "Benzene",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BENZENE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100412",
"SamplePackage": "N"
},
{
"NDCCode": "69329-310-00",
"PackageDescription": "1 KIT in 1 PACKAGE (69329-310-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 TUBE in 1 KIT > 237 mL in 1 TUBE (69329-323-01) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0228-2551-06)",
"NDC11Code": "69329-0310-00",
"ProductNDC": "69329-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deramsilkrx Anodynexa Pak",
"NonProprietaryName": "Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20150612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074514",
"LabelerName": "Patchwerx Labs, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-046-06",
"PackageDescription": "5 BLISTER PACK in 1 TRAY (64764-046-06) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64764-0046-06",
"ProductNDC": "64764-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prevacid",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19950510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020406",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950510",
"SamplePackage": "N",
"IndicationAndUsage": "PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide."
},
{
"NDCCode": "64764-065-06",
"PackageDescription": "6 BOTTLE, PLASTIC in 1 CARTON (64764-065-06) / 160 mg in 1 BOTTLE, PLASTIC",
"NDC11Code": "64764-0065-06",
"ProductNDC": "64764-065",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vedolizumab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20251020",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VEDOLIZUMAB",
"StrengthNumber": "160",
"StrengthUnit": "mg/160mg",
"Status": "Unfinished",
"LastUpdate": "2026-05-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20-OCT-25"
},
{
"NDCCode": "64764-075-06",
"PackageDescription": "6 BOTTLE, PLASTIC in 1 CARTON (64764-075-06) / 95 mg in 1 BOTTLE, PLASTIC",
"NDC11Code": "64764-0075-06",
"ProductNDC": "64764-075",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vedolizumab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240826",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "VEDOLIZUMAB",
"StrengthNumber": "95",
"StrengthUnit": "mg/95mg",
"Status": "Unfinished",
"LastUpdate": "2026-05-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "26-AUG-24"
},
{
"NDCCode": "64764-119-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06) ",
"NDC11Code": "64764-0119-06",
"ProductNDC": "64764-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colcrys",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022352",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090901",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "COLCRYS (colchicine, USP) is an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1)., 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
"Description": "Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine occurs as a pale yellow powder that is soluble in water. COLCRYS (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575\" × 0.3030\"), debossed with \"AR 374\" on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "64764-121-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-121-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0121-06",
"ProductNDC": "64764-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "12.5; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-123-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-123-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0123-06",
"ProductNDC": "64764-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "12.5; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-124-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-124-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0124-06",
"ProductNDC": "64764-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "12.5; 45",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-151-06",
"PackageDescription": "500 TABLET in 1 BOTTLE (64764-151-06) ",
"NDC11Code": "64764-0151-06",
"ProductNDC": "64764-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actos",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021073",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19990715",
"SamplePackage": "N",
"IndicationAndUsage": "Monotherapy and Combination Therapy. ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].",
"Description": "ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
},
{
"NDCCode": "64764-251-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-251-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0251-06",
"ProductNDC": "64764-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-254-06",
"PackageDescription": "4 CARTON in 1 TRAY (64764-254-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64764-0254-06",
"ProductNDC": "64764-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseni",
"NonProprietaryName": "Alogliptin And Pioglitazone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022426",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"SubstanceName": "ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "25; 45",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64764-105-00",
"PackageDescription": "10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01) ",
"NDC11Code": "64764-0105-00",
"ProductNDC": "64764-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eohilia",
"NonProprietaryName": "Budesonide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213976",
"LabelerName": "TAKEDA PHARMACEUTICALS AMERICA, INC.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1), Clinical Studies (14)].",
"Description": "EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.53. Its structural formula is. Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension. Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "64764-105-60",
"PackageDescription": "60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10) ",
"NDC11Code": "64764-0105-60",
"ProductNDC": "64764-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eohilia",
"NonProprietaryName": "Budesonide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213976",
"LabelerName": "TAKEDA PHARMACEUTICALS AMERICA, INC.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1), Clinical Studies (14)].",
"Description": "EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.53. Its structural formula is. Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension. Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "0703-9503-03",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) ",
"NDC11Code": "00703-9503-03",
"ProductNDC": "0703-9503",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911101",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "0703-9514-03",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) ",
"NDC11Code": "00703-9514-03",
"ProductNDC": "0703-9514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911101",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "0703-9514-83",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) ",
"NDC11Code": "00703-9514-83",
"ProductNDC": "0703-9514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073303",
"LabelerName": "Teva Parenteral Medicines, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "80; 16",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240711",
"SamplePackage": "N",
"Description": "Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28."
},
{
"NDCCode": "0703-9514-93",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) ",
"NDC11Code": "00703-9514-93",
"ProductNDC": "0703-9514",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
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<ProductNDC>68428-253</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzinum</ProprietaryName>
<NonProprietaryName>Benzene</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BENZENE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69329-310-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (69329-310-00) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60) * 1 TUBE in 1 KIT > 237 mL in 1 TUBE (69329-323-01) * 1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0228-2551-06)</PackageDescription>
<NDC11Code>69329-0310-00</NDC11Code>
<ProductNDC>69329-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deramsilkrx Anodynexa Pak</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074514</ApplicationNumber>
<LabelerName>Patchwerx Labs, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-046-06</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 TRAY (64764-046-06) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0046-06</NDC11Code>
<ProductNDC>64764-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prevacid</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020406</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PREVACID and PREVACID SoluTab are proton pump inhibitors (PPIs) indicated for the: 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartamePhenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet., glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>64764-065-06</NDCCode>
<PackageDescription>6 BOTTLE, PLASTIC in 1 CARTON (64764-065-06) / 160 mg in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>64764-0065-06</NDC11Code>
<ProductNDC>64764-065</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vedolizumab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20251020</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VEDOLIZUMAB</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/160mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-14</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-OCT-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64764-075-06</NDCCode>
<PackageDescription>6 BOTTLE, PLASTIC in 1 CARTON (64764-075-06) / 95 mg in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>64764-0075-06</NDC11Code>
<ProductNDC>64764-075</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vedolizumab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240826</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>VEDOLIZUMAB</SubstanceName>
<StrengthNumber>95</StrengthNumber>
<StrengthUnit>mg/95mg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-05-14</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64764-119-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06) </PackageDescription>
<NDC11Code>64764-0119-06</NDC11Code>
<ProductNDC>64764-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colcrys</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022352</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLCRYS (colchicine, USP) is an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1)., 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).</IndicationAndUsage>
<Description>Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C22H25NO6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine occurs as a pale yellow powder that is soluble in water. COLCRYS (colchicine, USP) tablets are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575" × 0.3030"), debossed with "AR 374" on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine USP. Inactive ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>64764-121-06</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (64764-121-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0121-06</NDC11Code>
<ProductNDC>64764-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseni</ProprietaryName>
<NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022426</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-123-06</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (64764-123-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0123-06</NDC11Code>
<ProductNDC>64764-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseni</ProprietaryName>
<NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022426</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-124-06</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (64764-124-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0124-06</NDC11Code>
<ProductNDC>64764-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseni</ProprietaryName>
<NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022426</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 45</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-151-06</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64764-151-06) </PackageDescription>
<NDC11Code>64764-0151-06</NDC11Code>
<ProductNDC>64764-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actos</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021073</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Monotherapy and Combination Therapy. ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)]. Important Limitations of Use. ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].</IndicationAndUsage>
<Description>ACTOS tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. ACTOS is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>64764-251-06</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (64764-251-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0251-06</NDC11Code>
<ProductNDC>64764-251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseni</ProprietaryName>
<NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022426</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-254-06</NDCCode>
<PackageDescription>4 CARTON in 1 TRAY (64764-254-06) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64764-0254-06</NDC11Code>
<ProductNDC>64764-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseni</ProprietaryName>
<NonProprietaryName>Alogliptin And Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022426</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<SubstanceName>ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 45</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64764-105-00</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (64764-105-00) / 10 mL in 1 POUCH (64764-105-01) </PackageDescription>
<NDC11Code>64764-0105-00</NDC11Code>
<ProductNDC>64764-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eohilia</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213976</ApplicationNumber>
<LabelerName>TAKEDA PHARMACEUTICALS AMERICA, INC.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1), Clinical Studies (14)].</IndicationAndUsage>
<Description>EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.53. Its structural formula is. Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension. Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<PackageDescription>60 POUCH in 1 CARTON (64764-105-60) / 10 mL in 1 POUCH (64764-105-10) </PackageDescription>
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<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213976</ApplicationNumber>
<LabelerName>TAKEDA PHARMACEUTICALS AMERICA, INC.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1), Clinical Studies (14)].</IndicationAndUsage>
<Description>EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.53. Its structural formula is. Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension. Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
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<NDC>
<NDCCode>0703-9503-03</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) </PackageDescription>
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<ProductNDC>0703-9503</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-9514-03</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) </PackageDescription>
<NDC11Code>00703-9514-03</NDC11Code>
<ProductNDC>0703-9514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-9514-83</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) </PackageDescription>
<NDC11Code>00703-9514-83</NDC11Code>
<ProductNDC>0703-9514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-9514-93</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) </PackageDescription>
<NDC11Code>00703-9514-93</NDC11Code>
<ProductNDC>0703-9514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
</NDC>
<NDC>
<NDCCode>0703-9526-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0703-9526-01) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00703-9526-01</NDC11Code>
<ProductNDC>0703-9526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073303</ApplicationNumber>
<LabelerName>Teva Parenteral Medicines, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>80; 16</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria. : 1 Pneumocystis jirovecii Pneumonia (1.1), 2 Shigellosis (1.2), 3 Urinary Tract Infections (1.3).</IndicationAndUsage>
<Description>Sulfamethoxazole and Trimethoprim Injection USP, a clear, colorless to slight yellow, sterile solution for intravenous infusion only, is a combination of sulfamethoxazole USP, a sulfonamide antimicrobial, and trimethoprim USP, a dihydrofolate reductase inhibitor antibacterial. Each mL contains: sulfamethoxazole, USP 80 mg; trimethoprim, USP 16 mg; benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; diethanolamine 3 mg (0.3% v/v and 0.3% w/v); ethyl alcohol 100 mg (12.3% v/v and 10.0% w/v); propylene glycol 400 mg (38.6% v/v and 40.0% w/v); sodium metabisulfite 1 mg as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH: 9.5 to 10.5. Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula. C14H18N4O3 M.W. 290.32. Sulfamethoxazole, USP is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. C10H11N3O3S M.W. 253.28.</Description>
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