{
"NDC": [
{
"NDCCode": "69097-224-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69097-224-16) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0224-16",
"ProductNDC": "69097-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-224-76",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0224-76",
"ProductNDC": "69097-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "62802-224-16",
"PackageDescription": "475 mL in 1 BOTTLE (62802-224-16)",
"NDC11Code": "62802-0224-16",
"ProductNDC": "62802-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No-ad 60 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sun & Skin Care Research, LLC",
"SubstanceName": "HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE",
"StrengthNumber": "15; 5; 6; 2",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70147-224-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (70147-224-16)",
"NDC11Code": "70147-0224-16",
"ProductNDC": "70147-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glen Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride And Pyrilamine Maleate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20151205",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Glendale Inc",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "15; 16",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 temporarily restores freer breathing through the nose, 7 reduces swelling of nasal passages."
},
{
"NDCCode": "69097-030-63",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16) ",
"NDC11Code": "69097-0030-63",
"ProductNDC": "69097-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nilotinib",
"NonProprietaryName": "Nilotinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250618",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218922",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "NILOTINIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250618",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "Nilotinib Capsules is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2).",
"Description": "Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C32H28F3N7O7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pKa1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate. Its structure is shown below:. Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "69097-223-16",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK",
"NDC11Code": "69097-0223-16",
"ProductNDC": "69097-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alendronate Sodium",
"NonProprietaryName": "Alendronate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076768",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "ALENDRONATE SODIUM",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080804",
"SamplePackage": "N",
"IndicationAndUsage": "Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).",
"Description": "Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch."
},
{
"NDCCode": "69097-372-47",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (69097-372-47) > 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "69097-0372-47",
"ProductNDC": "69097-372",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel Anhydrous",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209634",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "160",
"StrengthUnit": "mg/16mL",
"Pharm_Classes": "Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N"
},
{
"NDCCode": "69097-526-16",
"PackageDescription": "4 TABLET, FILM COATED in 1 CARTON (69097-526-16) ",
"NDC11Code": "69097-0526-16",
"ProductNDC": "69097-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210255",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190205",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).",
"Description": "Tadalafil tablets, an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a- hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP 20 mg are available brown colored, capsule shaped, biconvex film coated tablet with 'Cipla' debossed on one side and 526 on other side. Each tablet contains 20 mg of tadalafil and the following inactive ingredients: : croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, titanium dioxide and triacetin."
},
{
"NDCCode": "69097-055-97",
"PackageDescription": "25 VIAL in 1 CARTON (69097-055-97) / 50 mL in 1 VIAL (69097-055-67) ",
"NDC11Code": "69097-0055-97",
"ProductNDC": "69097-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217892",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "69097-077-97",
"PackageDescription": "25 VIAL in 1 CARTON (69097-077-97) / 15 mL in 1 VIAL (69097-077-67) ",
"NDC11Code": "69097-0077-97",
"ProductNDC": "69097-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217892",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "69097-078-97",
"PackageDescription": "25 VIAL in 1 CARTON (69097-078-97) / 5 mL in 1 VIAL (69097-078-67) ",
"NDC11Code": "69097-0078-97",
"ProductNDC": "69097-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217892",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "69097-438-02",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-438-02) ",
"NDC11Code": "69097-0438-02",
"ProductNDC": "69097-438",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218853",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3, 4-dichloro phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-1 naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCI is represented by the following structural formula. Sertraline hydrochloride is a white to off-white, crystalline powder that is sparingly soluble in ethanol, slightly soluble in water and in isopropyl alcohol. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, gelatin, purified water. Ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives."
},
{
"NDCCode": "69097-451-02",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69097-451-02) ",
"NDC11Code": "69097-0451-02",
"ProductNDC": "69097-451",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218853",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250717",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.",
"Description": "Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3, 4-dichloro phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-1 naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCI is represented by the following structural formula. Sertraline hydrochloride is a white to off-white, crystalline powder that is sparingly soluble in ethanol, slightly soluble in water and in isopropyl alcohol. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, gelatin, purified water. Ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives."
},
{
"NDCCode": "0054-0650-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0650-25) ",
"NDC11Code": "00054-0650-25",
"ProductNDC": "0054-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215138",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 300; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg."
},
{
"NDCCode": "0054-3000-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-3000-01) ",
"NDC11Code": "00054-3000-01",
"ProductNDC": "0054-3000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215138",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220509",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg."
},
{
"NDCCode": "0527-1312-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-1312-01) ",
"NDC11Code": "00527-1312-01",
"ProductNDC": "0527-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Aspirin, Caffeine And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074951",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "325; 50; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19980831",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.",
"Description": "Each capsule for oral administration contains. codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr)butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mgcaffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mgaspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is 7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37 and its molecular formula is C18H21NO3H3PO4½H2O. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder, is a short- to intermediate-acting barbiturate. Its molecular weight is 224.26 and its molecular formula is C11H16N2O3. Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant which occurs as a white powder or white glistening needles. Its molecular weight is (anhydrous) 194.19 and its molecular formula is C8H10N4O2. Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C9H8O4 and its molecular weight is 180.16. Inactive Ingredients: D&C Yellow #10, D&C Yellow #10 Aluminum Lake, D&C Red #33, D&C Red #28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Blue #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide, stearic acid, colloidal silicon dioxide."
},
{
"NDCCode": "0527-4094-37",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37) ",
"NDC11Code": "00527-4094-37",
"ProductNDC": "0527-4094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212083",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2022-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191217",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in capsule form for oral administration. Each capsule contains. Butalbital ................... 50 mg. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: pregelatinized starch, talc, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black iron oxide, FD&C blue #1. Imprinting ink composed of shellac glaze, black iron oxide, n-butyl alcohol, propylene glycol, FD&C blue #2, FD&C red #40, D&C yellow #10, FD&C blue #1. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19."
},
{
"NDCCode": "0527-4095-37",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0527-4095-37) ",
"NDC11Code": "00527-4095-37",
"ProductNDC": "0527-4095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212082",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 300; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2023-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191217",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: pregelatinized starch, talc, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black iron oxide, yellow iron oxide, FD&C blue #1. Imprinting ink composed of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide, ammonium hydroxide, and simethicone. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:."
},
{
"NDCCode": "0722-7029-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0722-7029-01) ",
"NDC11Code": "00722-7029-01",
"ProductNDC": "0722-7029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040885",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 300; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091116",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, D&C yellow #10, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:."
},
{
"NDCCode": "0722-7029-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0722-7029-05) ",
"NDC11Code": "00722-7029-05",
"ProductNDC": "0722-7029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen, And Caffeine Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040885",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 300; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091116",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, D&C yellow #10, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:."
},
{
"NDCCode": "0722-7075-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0722-7075-01) ",
"NDC11Code": "00722-7075-01",
"ProductNDC": "0722-7075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090956",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "50; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110823",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg. In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients: Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. MOLECULAR WEIGHT = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MOLECULAR WEIGHT = 151.16."
},
{
"NDCCode": "0781-2270-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2270-01) ",
"NDC11Code": "00781-2270-01",
"ProductNDC": "0781-2270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, And Caffeine",
"NonProprietaryName": "Butalbital, Aspirin, And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086996",
"LabelerName": "Sandoz Inc",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, aspirin, and caffeine capsules, USP are supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP 50 mg. aspirin, USP 325 mg. caffeine, USP 40 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following. Molecular Formula: C11H16N2O3. Molecular Weight: 224.26. Structural Formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following. Molecular Formula: C9H8O4. Molecular Weight: 180.16. Structural Formula. Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant. It has the following. Molecular Formula: C8H10N4O2. Molecular Weight: 194.19. Structural Formula. Inactive Ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake."
},
{
"NDCCode": "10135-628-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-628-01)",
"NDC11Code": "10135-0628-01",
"ProductNDC": "10135-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207118",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; BUTALBITAL",
"StrengthNumber": "300; 40; 50",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula."
},
{
"NDCCode": "11534-187-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (11534-187-01) ",
"NDC11Code": "11534-0187-01",
"ProductNDC": "11534-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207118",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; BUTALBITAL",
"StrengthNumber": "300; 40; 50",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP……………………50 mg. Acetaminophen, USP…………….300 mg. Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula."
},
{
"NDCCode": "11534-187-04",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (11534-187-04) ",
"NDC11Code": "11534-0187-04",
"ProductNDC": "11534-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207118",
"LabelerName": "SUNRISE PHARMACEUTICAL, INC",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; BUTALBITAL",
"StrengthNumber": "300; 40; 50",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170110",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP……………………50 mg. Acetaminophen, USP…………….300 mg. Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula."
},
{
"NDCCode": "11584-0030-1",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1) ",
"NDC11Code": "11584-0030-01",
"ProductNDC": "11584-0030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tencon",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089987",
"LabelerName": "El Dorado Distributors LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "50; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131010",
"SamplePackage": "N",
"IndicationAndUsage": "Tencon (butalbital and acetaminophen) Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital and acetaminophen are supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C 11H 16N 2O 3. MW = 224.26. Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:. C 8H 9NO 2. MW = 151.16. Each Tencon Tablet contains. Butalbital ……………………………… 50 mg. Warning: May be habit-forming. Acetaminophen ………………………… 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "13925-535-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13925-535-01) ",
"NDC11Code": "13925-0535-01",
"ProductNDC": "13925-535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214087",
"LabelerName": "Seton Pharmaceuticals LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 300; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each 50 mg/325 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. Each 50 mg/300 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 300 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized starch, Povidone, Crospovidone, Stearic Acid with 50 mg/325 mg/40 mg capsule shell composed of gelatin and titanium dioxide and 50 mg/300 mg/40 mg capsule shell composed of gelatin, titanium dioxide, FD&C Yellow 6, FD&C blue 1 and FD&C Red 40. Imprinting ink composed of Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19."
},
{
"NDCCode": "13925-536-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13925-536-01) ",
"NDC11Code": "13925-0536-01",
"ProductNDC": "13925-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214087",
"LabelerName": "Seton Pharmaceuticals LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220302",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each 50 mg/325 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. Each 50 mg/300 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 300 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized starch, Povidone, Crospovidone, Stearic Acid with 50 mg/325 mg/40 mg capsule shell composed of gelatin and titanium dioxide and 50 mg/300 mg/40 mg capsule shell composed of gelatin, titanium dioxide, FD&C Yellow 6, FD&C blue 1 and FD&C Red 40. Imprinting ink composed of Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19."
},
{
"NDCCode": "16590-911-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-911-30)",
"NDC11Code": "16590-0911-30",
"ProductNDC": "16590-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, And Caffeine",
"NonProprietaryName": "Butalbital, Aspirin, And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760504",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017534",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide."
},
{
"NDCCode": "16590-911-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16590-911-60)",
"NDC11Code": "16590-0911-60",
"ProductNDC": "16590-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Aspirin, And Caffeine",
"NonProprietaryName": "Butalbital, Aspirin, And Caffeine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760504",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA017534",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
"Description": "Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>69097-224-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69097-224-16) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0224-16</NDC11Code>
<ProductNDC>69097-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-224-76</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0224-76</NDC11Code>
<ProductNDC>69097-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>62802-224-16</NDCCode>
<PackageDescription>475 mL in 1 BOTTLE (62802-224-16)</PackageDescription>
<NDC11Code>62802-0224-16</NDC11Code>
<ProductNDC>62802-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No-ad 60 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sun & Skin Care Research, LLC</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE</SubstanceName>
<StrengthNumber>15; 5; 6; 2</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70147-224-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (70147-224-16)</PackageDescription>
<NDC11Code>70147-0224-16</NDC11Code>
<ProductNDC>70147-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glen Pe</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151205</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Glendale Inc</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>15; 16</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion, 6 temporarily restores freer breathing through the nose, 7 reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69097-030-63</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (69097-030-63) / 4 CAPSULE in 1 BLISTER PACK (69097-030-16) </PackageDescription>
<NDC11Code>69097-0030-63</NDC11Code>
<ProductNDC>69097-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nilotinib</ProprietaryName>
<NonProprietaryName>Nilotinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250618</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218922</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>NILOTINIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250618</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nilotinib Capsules is a kinase inhibitor indicated for the treatment of: : 1 Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1) , 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2).</IndicationAndUsage>
<Description>Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C32H28F3N7O7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pKa1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate. Its structure is shown below:. Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69097-223-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69097-0223-16</NDC11Code>
<ProductNDC>69097-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alendronate Sodium</ProprietaryName>
<NonProprietaryName>Alendronate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076768</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>ALENDRONATE SODIUM</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alendronate sodium is a bisphosphonate indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2), 2 Treatment to increase bone mass in men with osteoporosis (1.3), 3 Treatment of glucocorticoid-induced osteoporosis (1.4), 4 Treatment of Paget's disease of bone (1.5).</IndicationAndUsage>
<Description>Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P23H2O and its formula weight is 325.12. The structural formula is. Alendronate sodium is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.</Description>
</NDC>
<NDC>
<NDCCode>69097-372-47</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (69097-372-47) > 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>69097-0372-47</NDC11Code>
<ProductNDC>69097-372</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel Anhydrous</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209634</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/16mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-526-16</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 CARTON (69097-526-16) </PackageDescription>
<NDC11Code>69097-0526-16</NDC11Code>
<ProductNDC>69097-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210255</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1).</IndicationAndUsage>
<Description>Tadalafil tablets, an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a- hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP 20 mg are available brown colored, capsule shaped, biconvex film coated tablet with 'Cipla' debossed on one side and 526 on other side. Each tablet contains 20 mg of tadalafil and the following inactive ingredients: : croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>69097-055-97</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (69097-055-97) / 50 mL in 1 VIAL (69097-055-67) </PackageDescription>
<NDC11Code>69097-0055-97</NDC11Code>
<ProductNDC>69097-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217892</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>69097-077-97</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (69097-077-97) / 15 mL in 1 VIAL (69097-077-67) </PackageDescription>
<NDC11Code>69097-0077-97</NDC11Code>
<ProductNDC>69097-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217892</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>69097-078-97</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (69097-078-97) / 5 mL in 1 VIAL (69097-078-67) </PackageDescription>
<NDC11Code>69097-0078-97</NDC11Code>
<ProductNDC>69097-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217892</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>69097-438-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-438-02) </PackageDescription>
<NDC11Code>69097-0438-02</NDC11Code>
<ProductNDC>69097-438</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218853</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3, 4-dichloro phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-1 naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCI is represented by the following structural formula. Sertraline hydrochloride is a white to off-white, crystalline powder that is sparingly soluble in ethanol, slightly soluble in water and in isopropyl alcohol. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, gelatin, purified water. Ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.</Description>
</NDC>
<NDC>
<NDCCode>69097-451-02</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69097-451-02) </PackageDescription>
<NDC11Code>69097-0451-02</NDC11Code>
<ProductNDC>69097-451</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218853</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride is indicated for the treatment of the following [see Clinical Studies (14)]: 1 Major depressive disorder (MDD) in adults, 2 Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older.</IndicationAndUsage>
<Description>Sertraline hydrochloride capsules contain sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI). Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3, 4-dichloro phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-1 naphthylamine hydrochloride. The empirical formula C17H17Cl2N HCI is represented by the following structural formula. Sertraline hydrochloride is a white to off-white, crystalline powder that is sparingly soluble in ethanol, slightly soluble in water and in isopropyl alcohol. Sertraline hydrochloride capsules is for oral administration and contain 168 mg and 224 mg sertraline hydrochloride, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, gelatin, purified water. Ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide. The 150 mg capsules contain FD&C Yellow No. 5 as a color additive. The 200 mg capsules contain FD&C Blue No. 1 and FD&C Yellow No. 5 as color additives.</Description>
</NDC>
<NDC>
<NDCCode>0054-0650-25</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-0650-25) </PackageDescription>
<NDC11Code>00054-0650-25</NDC11Code>
<ProductNDC>0054-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215138</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 300; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg.</Description>
</NDC>
<NDC>
<NDCCode>0054-3000-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-3000-01) </PackageDescription>
<NDC11Code>00054-3000-01</NDC11Code>
<ProductNDC>0054-3000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215138</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….300 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain. Butalbital, USP……………………50 mgAcetaminophen, USP…………….325 mgCaffeine, USP……………………..40 mg. Codeine Phosphate, USP………….30 mg. Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. MW = 224.26. Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MW = 151.16. Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:. C8H10N4O2. MW = 194.19. Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. C18H21NO3H3PO41/2H2O. MW = 406.37. Inactive Ingredients: pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg.</Description>
</NDC>
<NDC>
<NDCCode>0527-1312-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-1312-01) </PackageDescription>
<NDC11Code>00527-1312-01</NDC11Code>
<ProductNDC>0527-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Caffeine And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074951</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>325; 50; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each capsule for oral administration contains. codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr)butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mgcaffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mgaspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is 7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37 and its molecular formula is C18H21NO3H3PO4½H2O. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder, is a short- to intermediate-acting barbiturate. Its molecular weight is 224.26 and its molecular formula is C11H16N2O3. Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant which occurs as a white powder or white glistening needles. Its molecular weight is (anhydrous) 194.19 and its molecular formula is C8H10N4O2. Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C9H8O4 and its molecular weight is 180.16. Inactive Ingredients: D&C Yellow #10, D&C Yellow #10 Aluminum Lake, D&C Red #33, D&C Red #28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Blue #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide, stearic acid, colloidal silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0527-4094-37</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0527-4094-37) </PackageDescription>
<NDC11Code>00527-4094-37</NDC11Code>
<ProductNDC>0527-4094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212083</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in capsule form for oral administration. Each capsule contains. Butalbital ................... 50 mg. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: pregelatinized starch, talc, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black iron oxide, FD&C blue #1. Imprinting ink composed of shellac glaze, black iron oxide, n-butyl alcohol, propylene glycol, FD&C blue #2, FD&C red #40, D&C yellow #10, FD&C blue #1. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19.</Description>
</NDC>
<NDC>
<NDCCode>0527-4095-37</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0527-4095-37) </PackageDescription>
<NDC11Code>00527-4095-37</NDC11Code>
<ProductNDC>0527-4095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212082</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: pregelatinized starch, talc, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black iron oxide, yellow iron oxide, FD&C blue #1. Imprinting ink composed of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide, ammonium hydroxide, and simethicone. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0722-7029-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0722-7029-01) </PackageDescription>
<NDC11Code>00722-7029-01</NDC11Code>
<ProductNDC>0722-7029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040885</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, D&C yellow #10, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0722-7029-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0722-7029-05) </PackageDescription>
<NDC11Code>00722-7029-05</NDC11Code>
<ProductNDC>0722-7029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, And Caffeine Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040885</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. butalbital USP……………………50 mgacetaminophen USP…………….300 mgcaffeine USP……………………..40 mg. Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, D&C yellow #10, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>0722-7075-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0722-7075-01) </PackageDescription>
<NDC11Code>00722-7075-01</NDC11Code>
<ProductNDC>0722-7075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital And Acetaminophen</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090956</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>50; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg, Acetaminophen, USP 300 mg. In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients: Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. MOLECULAR WEIGHT = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. MOLECULAR WEIGHT = 151.16.</Description>
</NDC>
<NDC>
<NDCCode>0781-2270-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2270-01) </PackageDescription>
<NDC11Code>00781-2270-01</NDC11Code>
<ProductNDC>0781-2270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086996</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, aspirin, and caffeine capsules, USP are supplied in capsule form for oral administration. Each capsule contains the following active ingredients:butalbital, USP 50 mg. aspirin, USP 325 mg. caffeine, USP 40 mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following. Molecular Formula: C11H16N2O3. Molecular Weight: 224.26. Structural Formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following. Molecular Formula: C9H8O4. Molecular Weight: 180.16. Structural Formula. Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant. It has the following. Molecular Formula: C8H10N4O2. Molecular Weight: 194.19. Structural Formula. Inactive Ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>10135-628-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (10135-628-01)</PackageDescription>
<NDC11Code>10135-0628-01</NDC11Code>
<ProductNDC>10135-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207118</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; BUTALBITAL</SubstanceName>
<StrengthNumber>300; 40; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>11534-187-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (11534-187-01) </PackageDescription>
<NDC11Code>11534-0187-01</NDC11Code>
<ProductNDC>11534-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207118</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; BUTALBITAL</SubstanceName>
<StrengthNumber>300; 40; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP……………………50 mg. Acetaminophen, USP…………….300 mg. Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>11534-187-04</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (11534-187-04) </PackageDescription>
<NDC11Code>11534-0187-04</NDC11Code>
<ProductNDC>11534-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207118</ApplicationNumber>
<LabelerName>SUNRISE PHARMACEUTICAL, INC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; BUTALBITAL</SubstanceName>
<StrengthNumber>300; 40; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP……………………50 mg. Acetaminophen, USP…………….300 mg. Caffeine, USP……………………..40 mg. Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium dioxide. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula. Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>11584-0030-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1) </PackageDescription>
<NDC11Code>11584-0030-01</NDC11Code>
<ProductNDC>11584-0030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tencon</ProprietaryName>
<NonProprietaryName>Butalbital And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089987</ApplicationNumber>
<LabelerName>El Dorado Distributors LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>50; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tencon (butalbital and acetaminophen) Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital and acetaminophen are supplied in tablet form for oral administration. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C 11H 16N 2O 3. MW = 224.26. Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:. C 8H 9NO 2. MW = 151.16. Each Tencon Tablet contains. Butalbital ……………………………… 50 mg. Warning: May be habit-forming. Acetaminophen ………………………… 325 mg. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>13925-535-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13925-535-01) </PackageDescription>
<NDC11Code>13925-0535-01</NDC11Code>
<ProductNDC>13925-535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214087</ApplicationNumber>
<LabelerName>Seton Pharmaceuticals LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 300; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each 50 mg/325 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. Each 50 mg/300 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 300 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized starch, Povidone, Crospovidone, Stearic Acid with 50 mg/325 mg/40 mg capsule shell composed of gelatin and titanium dioxide and 50 mg/300 mg/40 mg capsule shell composed of gelatin, titanium dioxide, FD&C Yellow 6, FD&C blue 1 and FD&C Red 40. Imprinting ink composed of Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19.</Description>
</NDC>
<NDC>
<NDCCode>13925-536-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13925-536-01) </PackageDescription>
<NDC11Code>13925-0536-01</NDC11Code>
<ProductNDC>13925-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Acetaminophen And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214087</ApplicationNumber>
<LabelerName>Seton Pharmaceuticals LLC</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each 50 mg/325 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 325 mg. Caffeine ...................... 40 mg. Each 50 mg/300 mg/40 mg capsule contains. Butalbital ................... 50 mg. Warning: May be habit-forming. Acetaminophen ........ 300 mg. Caffeine ...................... 40 mg. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Pregelatinized starch, Povidone, Crospovidone, Stearic Acid with 50 mg/325 mg/40 mg capsule shell composed of gelatin and titanium dioxide and 50 mg/300 mg/40 mg capsule shell composed of gelatin, titanium dioxide, FD&C Yellow 6, FD&C blue 1 and FD&C Red 40. Imprinting ink composed of Black Iron Oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Shellac and Strong Ammonia Solution. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula. C11H16N2O3. MW = 224.26. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C8H9NO2. MW = 151.16. Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula. C8H10N4O2. MW = 194.19.</Description>
</NDC>
<NDC>
<NDCCode>16590-911-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16590-911-30)</PackageDescription>
<NDC11Code>16590-0911-30</NDC11Code>
<ProductNDC>16590-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760504</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017534</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>16590-911-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16590-911-60)</PackageDescription>
<NDC11Code>16590-0911-60</NDC11Code>
<ProductNDC>16590-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butalbital, Aspirin, And Caffeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, And Caffeine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760504</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA017534</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.</IndicationAndUsage>
<Description>Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. C11H16N2O3 molecular weight 224.26. Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula. C9H8O4 molecular weight 180.16. Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula. C8H10N4O2 molecular weight 194.19. Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide.</Description>
</NDC>
</NDCList>