{
"NDC": [
{
"NDCCode": "79739-7097-1",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1) ",
"NDC11Code": "79739-7097-01",
"ProductNDC": "79739-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091522",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120312",
"SamplePackage": "N",
"IndicationAndUsage": "For use as adjunctive therapy in the treatment of peptic ulcer.",
"Description": "Glycopyrrolate Tablets, USP 1.5 mg contains the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide. Each tablet contains:Glycopyrrolate, USP ............................. 1.5 mg. Inactive Ingredients: Dibasic Calcium Phosphate, Anhydrous Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate."
},
{
"NDCCode": "0270-7097-07",
"PackageDescription": "20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL",
"NDC11Code": "00270-7097-07",
"ProductNDC": "0270-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumason",
"NonProprietaryName": "Sulfur Hexafluoride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"RouteName": "INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203684",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "SULFUR HEXAFLUORIDE; DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)",
"StrengthNumber": "60.7; .19; .19",
"StrengthUnit": "mg/mg; mg/mg; mg/mg",
"Pharm_Classes": "Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Echocardiography. Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver. Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract. Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.",
"Description": "Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): 1 The single patient use kit contains the following three items:one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-capone prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent)Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL.one Mini-Spike, 2 The 20-vial pack is comprised of:twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gastwenty Mini-Spikestwenty peel-off syringe labels."
},
{
"NDCCode": "0270-7097-08",
"PackageDescription": "20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL",
"NDC11Code": "00270-7097-08",
"ProductNDC": "0270-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumason",
"NonProprietaryName": "Sulfur Hexafluoride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"RouteName": "INTRAVENOUS; INTRAVESICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203684",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "SULFUR HEXAFLUORIDE; DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)",
"StrengthNumber": "60.7; .19; .19",
"StrengthUnit": "mg/mg; mg/mg; mg/mg",
"Pharm_Classes": "Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N",
"IndicationAndUsage": "Echocardiography. Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver. Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract. Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.",
"Description": "Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): 1 The single patient use kit contains the following three items:one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-capone prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent)Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL.one Mini-Spike, 2 The 20-vial pack is comprised of:twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gastwenty Mini-Spikestwenty peel-off syringe labels."
},
{
"NDCCode": "0378-7097-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7097-05)",
"NDC11Code": "00378-7097-05",
"ProductNDC": "0378-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075817",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "0722-7097-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0722-7097-01) ",
"NDC11Code": "00722-7097-01",
"ProductNDC": "0722-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091522",
"LabelerName": "Nexgen Pharma, Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20120312",
"SamplePackage": "N",
"IndicationAndUsage": "For use as adjunctive therapy in the treatment of peptic ulcer.",
"Description": "Glycopyrrolate Tablets, USP 1.5 mg contains the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Each tablet contains. Glycopyrrolate, USP, 1.5 mg. Inactive Ingredients: Dibasic Calcium Phosphate, Anhydrous Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate."
},
{
"NDCCode": "0904-7097-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7097-61) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00904-7097-61",
"ProductNDC": "0904-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090687",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140813",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R* [E(1S*,3S*,4S*)], 4S*,5R*,8S*, 9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]5,6,8,11,12,13,14,15,16, 17,18, 19,24, 25,26, 26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12●H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, and magnesium stearate NF. The 0.5 mg capsule shell contains, FD & C Blue 1, FD & C Red 40, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains FD & C Blue 1, gelatin NF, iron oxide yellow and titanium dioxide USP, and the 5 mg capsule shell contains D & C Red 28, D & C Yellow 10, FD & C Blue 1, gelatin NF, and titanium dioxide USP."
},
{
"NDCCode": "48951-7097-4",
"PackageDescription": "1 POWDER in 1 BOTTLE, GLASS (48951-7097-4)",
"NDC11Code": "48951-7097-04",
"ProductNDC": "48951-7097",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Osteodoron Pm Bone Support",
"NonProprietaryName": "Oyster Shell Calcium Carbonate, Crude White Oak Bark Calcium Fluoride Silicon Dioxide",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; WHITE OAK BARK; CALCIUM FLUORIDE; SILICON DIOXIDE",
"StrengthNumber": "1; 4; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50090-7097-0",
"PackageDescription": "40 TABLET in 1 BOTTLE (50090-7097-0) ",
"NDC11Code": "50090-7097-00",
"ProductNDC": "50090-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "50090-7097-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (50090-7097-1) ",
"NDC11Code": "50090-7097-01",
"ProductNDC": "50090-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240227",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "50090-7097-5",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-7097-5) ",
"NDC11Code": "50090-7097-05",
"ProductNDC": "50090-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240227",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "68788-7097-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (68788-7097-1) > 150 mL in 1 BOTTLE",
"NDC11Code": "68788-7097-01",
"ProductNDC": "68788-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202027",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "16.05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180309",
"SamplePackage": "N"
},
{
"NDCCode": "71872-7097-1",
"PackageDescription": "1 CARTON in 1 BAG (71872-7097-1) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE",
"NDC11Code": "71872-7097-01",
"ProductNDC": "71872-7097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20000601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203449",
"LabelerName": "Medical Purchasing Solutions, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkalinizing Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191018",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.",
"Description": "Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in 8.4% concentration. See table in HOW SUPPLIED section for contents and characteristics. The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide may have been added to adjust the pH of the solution to approximately 8.0. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na + and HCO3¯ . Sodium Bicarbonate, USP is chemically designated NaHCO 3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H 2O."
},
{
"NDCCode": "79739-6094-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (79739-6094-1) ",
"NDC11Code": "79739-6094-01",
"ProductNDC": "79739-6094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ascomp With Codeine",
"NonProprietaryName": "Butalbital, Aspirin, Cafeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20011130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075231",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 325; 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": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is 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. 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, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP…………………50mg. Aspirin, USP……………………325mg. Caffeine, USP…………………..40mg. Codeine phosphate, USP………30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink."
},
{
"NDCCode": "79739-6670-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-1) ",
"NDC11Code": "79739-6670-01",
"ProductNDC": "79739-6670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076560",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"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": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040610",
"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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP ...................................................................................... 50 mg. Acetaminophen, USP ............................................................................. 325 mg. Caffeine, USP ........................................................................................ 40 mg. Codeine Phosphate, USP ......................................................................... 30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5_-epoxy-3-methoxy-17-methylmorphinan-6_-ol phosphate (1:1) (salt) hemihydrate), is an opioid agonist. It has the following structural formula. Inactive Ingredients: Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc. The gelatin capsules are printed with edible inks containing Titanium Dioxide, Gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40 and FD&C Yellow No. 5. [see Warnings and Precautions (5.21)]."
},
{
"NDCCode": "79739-6670-5",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-5) ",
"NDC11Code": "79739-6670-05",
"ProductNDC": "79739-6670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076560",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"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": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040610",
"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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP ...................................................................................... 50 mg. Acetaminophen, USP ............................................................................. 325 mg. Caffeine, USP ........................................................................................ 40 mg. Codeine Phosphate, USP ......................................................................... 30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5_-epoxy-3-methoxy-17-methylmorphinan-6_-ol phosphate (1:1) (salt) hemihydrate), is an opioid agonist. It has the following structural formula. Inactive Ingredients: Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc. The gelatin capsules are printed with edible inks containing Titanium Dioxide, Gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40 and FD&C Yellow No. 5. [see Warnings and Precautions (5.21)]."
},
{
"NDCCode": "79739-7028-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-1) ",
"NDC11Code": "79739-7028-01",
"ProductNDC": "79739-7028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076560",
"LabelerName": "LGM Pharma Solutions, LLC",
"SubstanceName": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "300; 50; 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": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20040610",
"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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1, 3, 7 trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: FD&C blue #1, FD&C yellow #6, D&C yellow #10, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "79739-7028-5",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-5) ",
"NDC11Code": "79739-7028-05",
"ProductNDC": "79739-7028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076560",
"LabelerName": "LGM Pharma Solutions, LLC",
"SubstanceName": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "300; 50; 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": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20040610",
"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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1, 3, 7 trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: FD&C blue #1, FD&C yellow #6, D&C yellow #10, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "79739-7075-1",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (79739-7075-1) ",
"NDC11Code": "79739-7075-01",
"ProductNDC": "79739-7075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butalbital And Acetaminophen",
"NonProprietaryName": "Butalbital And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090956",
"LabelerName": "LGM Pharma Solutions, LLC",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN",
"StrengthNumber": "50; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"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": "79739-7076-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (79739-7076-1) ",
"NDC11Code": "79739-7076-01",
"ProductNDC": "79739-7076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 500 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7076-5",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (79739-7076-5) ",
"NDC11Code": "79739-7076-05",
"ProductNDC": "79739-7076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 500 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7077-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (79739-7077-1) ",
"NDC11Code": "79739-7077-01",
"ProductNDC": "79739-7077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 750 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7078-1",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (79739-7078-1) ",
"NDC11Code": "79739-7078-01",
"ProductNDC": "79739-7078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 1000 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190904",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7078-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (79739-7078-3) ",
"NDC11Code": "79739-7078-03",
"ProductNDC": "79739-7078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 1000 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191002",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7078-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (79739-7078-6) ",
"NDC11Code": "79739-7078-06",
"ProductNDC": "79739-7078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone 1000 Mg",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "79739-7116-1",
"PackageDescription": "7 d in 1 BOTTLE (79739-7116-1) ",
"NDC11Code": "79739-7116-01",
"ProductNDC": "79739-7116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"NonProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090812",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/d",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "79739-7116-2",
"PackageDescription": "14 d in 1 BOTTLE (79739-7116-2) ",
"NDC11Code": "79739-7116-02",
"ProductNDC": "79739-7116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"NonProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090812",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/d",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "79739-7116-3",
"PackageDescription": "30 d in 1 BOTTLE (79739-7116-3) ",
"NDC11Code": "79739-7116-03",
"ProductNDC": "79739-7116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"NonProprietaryName": "Polyethylene Glycol 3350, Nf Powder For Solution, Laxative",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20091007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090812",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/d",
"Pharm_Classes": "Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091007",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days."
},
{
"NDCCode": "79739-7121-1",
"PackageDescription": "1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79739-7121-1) ",
"NDC11Code": "79739-7121-01",
"ProductNDC": "79739-7121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chenodiol",
"NonProprietaryName": "Chenodiol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091019",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "CHENODIOL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20091022",
"SamplePackage": "N",
"IndicationAndUsage": "Chenodiol is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. The likelihood of successful dissolution is far greater if the stones are floatable or small. For patients with nonfloatable stones, dissolution is less likely and added weight should be given to the risk that more emergent surgery might result from a delay due to unsuccessful treatment. Safety of use beyond 24 months is not established. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.",
"Description": "Chenodiol is the non-proprietary name for chenodeoxycholic acid, a naturally occurring human bile acid. It is a bitter-tasting white powder consisting of crystalline and amorphous particles freely soluble in methanol, acetone and acetic acid and practically insoluble in water. Its chemical name is 3α, 7α-dihydroxy-5β-cholan-24-oic acid (C24H40O4), it has a molecular weight of 392.58, and its structure is shown below;. Chenodiol film-coated tablets for oral administration contain 250 mg of Chenodiol. Inactive ingredients: pregelatinized starch; silicon dioxide; microcrystalline cellulose, sodium starch glycolate; and magnesium stearate; the thin-film coating contains: opadry YS-2-7035 [consisting of methylcellulose and glycerin] and sodium lauryl sulfate."
},
{
"NDCCode": "79739-7143-1",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (79739-7143-1) ",
"NDC11Code": "79739-7143-01",
"ProductNDC": "79739-7143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ursodiol 200 Mg",
"NonProprietaryName": "Usodiol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205789",
"LabelerName": "LGM PHARMA SOLUTIONS, LLC",
"SubstanceName": "URSODIOL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid [EPC], Bile Acids and Salts [CS]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.",
"Description": "Ursodiol is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. Ursodiol (ursodesoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Silicon dioxide, magnesium stearate, and corn starch. Gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains FD&C Yellow #6 and D&C Yellow #10."
}
]
}
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<NDCList>
<NDC>
<NDCCode>79739-7097-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (79739-7097-1) </PackageDescription>
<NDC11Code>79739-7097-01</NDC11Code>
<ProductNDC>79739-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091522</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as adjunctive therapy in the treatment of peptic ulcer.</IndicationAndUsage>
<Description>Glycopyrrolate Tablets, USP 1.5 mg contains the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1, 1-dimethylpyrrolidinium bromide. Each tablet contains:Glycopyrrolate, USP ............................. 1.5 mg. Inactive Ingredients: Dibasic Calcium Phosphate, Anhydrous Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.</Description>
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<NDC>
<NDCCode>0270-7097-07</NDCCode>
<PackageDescription>20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL</PackageDescription>
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<ProductNDC>0270-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumason</ProprietaryName>
<NonProprietaryName>Sulfur Hexafluoride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
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<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203684</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
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<StrengthNumber>60.7; .19; .19</StrengthNumber>
<StrengthUnit>mg/mg; mg/mg; mg/mg</StrengthUnit>
<Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Echocardiography. Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver. Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract. Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.</IndicationAndUsage>
<Description>Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): 1 The single patient use kit contains the following three items:one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-capone prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent)Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL.one Mini-Spike, 2 The 20-vial pack is comprised of:twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gastwenty Mini-Spikestwenty peel-off syringe labels.</Description>
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<NDC>
<NDCCode>0270-7097-08</NDCCode>
<PackageDescription>20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL</PackageDescription>
<NDC11Code>00270-7097-08</NDC11Code>
<ProductNDC>0270-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumason</ProprietaryName>
<NonProprietaryName>Sulfur Hexafluoride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION</DosageFormName>
<RouteName>INTRAVENOUS; INTRAVESICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203684</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>SULFUR HEXAFLUORIDE; DISTEAROYLPHOSPHATIDYLCHOLINE, DL-; SODIUM 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL)</SubstanceName>
<StrengthNumber>60.7; .19; .19</StrengthNumber>
<StrengthUnit>mg/mg; mg/mg; mg/mg</StrengthUnit>
<Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Echocardiography. Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver. Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract. Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.</IndicationAndUsage>
<Description>Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): 1 The single patient use kit contains the following three items:one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-capone prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent)Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL.one Mini-Spike, 2 The 20-vial pack is comprised of:twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gastwenty Mini-Spikestwenty peel-off syringe labels.</Description>
</NDC>
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<NDCCode>0378-7097-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7097-05)</PackageDescription>
<NDC11Code>00378-7097-05</NDC11Code>
<ProductNDC>0378-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075817</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0722-7097-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0722-7097-01) </PackageDescription>
<NDC11Code>00722-7097-01</NDC11Code>
<ProductNDC>0722-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091522</ApplicationNumber>
<LabelerName>Nexgen Pharma, Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as adjunctive therapy in the treatment of peptic ulcer.</IndicationAndUsage>
<Description>Glycopyrrolate Tablets, USP 1.5 mg contains the synthetic anticholinergic, glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. Each tablet contains. Glycopyrrolate, USP, 1.5 mg. Inactive Ingredients: Dibasic Calcium Phosphate, Anhydrous Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0904-7097-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7097-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7097-61</NDC11Code>
<ProductNDC>0904-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090687</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S-[3R* [E(1S*,3S*,4S*)], 4S*,5R*,8S*, 9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]5,6,8,11,12,13,14,15,16, 17,18, 19,24, 25,26, 26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus has an empirical formula of C44H69NO12●H2O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform. Tacrolimus is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose monohydrate NF, and magnesium stearate NF. The 0.5 mg capsule shell contains, FD & C Blue 1, FD & C Red 40, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains FD & C Blue 1, gelatin NF, iron oxide yellow and titanium dioxide USP, and the 5 mg capsule shell contains D & C Red 28, D & C Yellow 10, FD & C Blue 1, gelatin NF, and titanium dioxide USP.</Description>
</NDC>
<NDC>
<NDCCode>48951-7097-4</NDCCode>
<PackageDescription>1 POWDER in 1 BOTTLE, GLASS (48951-7097-4)</PackageDescription>
<NDC11Code>48951-7097-04</NDC11Code>
<ProductNDC>48951-7097</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Osteodoron Pm Bone Support</ProprietaryName>
<NonProprietaryName>Oyster Shell Calcium Carbonate, Crude White Oak Bark Calcium Fluoride Silicon Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; WHITE OAK BARK; CALCIUM FLUORIDE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>1; 4; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-7097-0</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (50090-7097-0) </PackageDescription>
<NDC11Code>50090-7097-00</NDC11Code>
<ProductNDC>50090-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg).</Description>
</NDC>
<NDC>
<NDCCode>50090-7097-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-7097-1) </PackageDescription>
<NDC11Code>50090-7097-01</NDC11Code>
<ProductNDC>50090-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg).</Description>
</NDC>
<NDC>
<NDCCode>50090-7097-5</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-7097-5) </PackageDescription>
<NDC11Code>50090-7097-05</NDC11Code>
<ProductNDC>50090-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg).</Description>
</NDC>
<NDC>
<NDCCode>68788-7097-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68788-7097-1) > 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68788-7097-01</NDC11Code>
<ProductNDC>68788-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202027</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>16.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71872-7097-1</NDCCode>
<PackageDescription>1 CARTON in 1 BAG (71872-7097-1) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>71872-7097-01</NDC11Code>
<ProductNDC>71872-7097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20000601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203449</ApplicationNumber>
<LabelerName>Medical Purchasing Solutions, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO 2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.</IndicationAndUsage>
<Description>Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in 8.4% concentration. See table in HOW SUPPLIED section for contents and characteristics. The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide may have been added to adjust the pH of the solution to approximately 8.0. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na + and HCO3¯ . Sodium Bicarbonate, USP is chemically designated NaHCO 3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H 2O.</Description>
</NDC>
<NDC>
<NDCCode>79739-6094-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (79739-6094-1) </PackageDescription>
<NDC11Code>79739-6094-01</NDC11Code>
<ProductNDC>79739-6094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ascomp With Codeine</ProprietaryName>
<NonProprietaryName>Butalbital, Aspirin, Cafeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075231</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 325; 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>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is 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. 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, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients. Butalbital, USP…………………50mg. Aspirin, USP……………………325mg. Caffeine, USP…………………..40mg. Codeine phosphate, USP………30mg. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has the following structural formula. Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: Corn Starch, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc, and Titanium Dioxide. The capsules are printed with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>79739-6670-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-1) </PackageDescription>
<NDC11Code>79739-6670-01</NDC11Code>
<ProductNDC>79739-6670</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>20040610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076560</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</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>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040610</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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP ...................................................................................... 50 mg. Acetaminophen, USP ............................................................................. 325 mg. Caffeine, USP ........................................................................................ 40 mg. Codeine Phosphate, USP ......................................................................... 30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5_-epoxy-3-methoxy-17-methylmorphinan-6_-ol phosphate (1:1) (salt) hemihydrate), is an opioid agonist. It has the following structural formula. Inactive Ingredients: Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc. The gelatin capsules are printed with edible inks containing Titanium Dioxide, Gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40 and FD&C Yellow No. 5. [see Warnings and Precautions (5.21)].</Description>
</NDC>
<NDC>
<NDCCode>79739-6670-5</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-5) </PackageDescription>
<NDC11Code>79739-6670-05</NDC11Code>
<ProductNDC>79739-6670</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>20040610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076560</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</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>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040610</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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP ...................................................................................... 50 mg. Acetaminophen, USP ............................................................................. 325 mg. Caffeine, USP ........................................................................................ 40 mg. Codeine Phosphate, USP ......................................................................... 30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5_-epoxy-3-methoxy-17-methylmorphinan-6_-ol phosphate (1:1) (salt) hemihydrate), is an opioid agonist. It has the following structural formula. Inactive Ingredients: Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc. The gelatin capsules are printed with edible inks containing Titanium Dioxide, Gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40 and FD&C Yellow No. 5. [see Warnings and Precautions (5.21)].</Description>
</NDC>
<NDC>
<NDCCode>79739-7028-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-1) </PackageDescription>
<NDC11Code>79739-7028-01</NDC11Code>
<ProductNDC>79739-7028</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>20040610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076560</ApplicationNumber>
<LabelerName>LGM Pharma Solutions, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 50; 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>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040610</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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1, 3, 7 trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: FD&C blue #1, FD&C yellow #6, D&C yellow #10, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>79739-7028-5</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (79739-7028-5) </PackageDescription>
<NDC11Code>79739-7028-05</NDC11Code>
<ProductNDC>79739-7028</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>20040610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076560</ApplicationNumber>
<LabelerName>LGM Pharma Solutions, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 50; 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>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040610</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. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1, 3, 7 trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (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. Inactive Ingredients: FD&C blue #1, FD&C yellow #6, D&C yellow #10, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>79739-7075-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (79739-7075-1) </PackageDescription>
<NDC11Code>79739-7075-01</NDC11Code>
<ProductNDC>79739-7075</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>LGM Pharma Solutions, LLC</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>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</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>79739-7076-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (79739-7076-1) </PackageDescription>
<NDC11Code>79739-7076-01</NDC11Code>
<ProductNDC>79739-7076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 500 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7076-5</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (79739-7076-5) </PackageDescription>
<NDC11Code>79739-7076-05</NDC11Code>
<ProductNDC>79739-7076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 500 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7077-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (79739-7077-1) </PackageDescription>
<NDC11Code>79739-7077-01</NDC11Code>
<ProductNDC>79739-7077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 750 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7077-5</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (79739-7077-5) </PackageDescription>
<NDC11Code>79739-7077-05</NDC11Code>
<ProductNDC>79739-7077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 750 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7078-1</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (79739-7078-1) </PackageDescription>
<NDC11Code>79739-7078-01</NDC11Code>
<ProductNDC>79739-7078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 1000 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7078-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (79739-7078-3) </PackageDescription>
<NDC11Code>79739-7078-03</NDC11Code>
<ProductNDC>79739-7078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 1000 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7078-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (79739-7078-6) </PackageDescription>
<NDC11Code>79739-7078-06</NDC11Code>
<ProductNDC>79739-7078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone 1000 Mg</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. C15H16O2 M.W. 228.3. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>79739-7116-1</NDCCode>
<PackageDescription>7 d in 1 BOTTLE (79739-7116-1) </PackageDescription>
<NDC11Code>79739-7116-01</NDC11Code>
<ProductNDC>79739-7116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090812</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/d</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79739-7116-2</NDCCode>
<PackageDescription>14 d in 1 BOTTLE (79739-7116-2) </PackageDescription>
<NDC11Code>79739-7116-02</NDC11Code>
<ProductNDC>79739-7116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090812</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/d</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79739-7116-3</NDCCode>
<PackageDescription>30 d in 1 BOTTLE (79739-7116-3) </PackageDescription>
<NDC11Code>79739-7116-03</NDC11Code>
<ProductNDC>79739-7116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090812</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/d</StrengthUnit>
<Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79739-7121-1</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79739-7121-1) </PackageDescription>
<NDC11Code>79739-7121-01</NDC11Code>
<ProductNDC>79739-7121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chenodiol</ProprietaryName>
<NonProprietaryName>Chenodiol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091019</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>CHENODIOL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chenodiol is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. The likelihood of successful dissolution is far greater if the stones are floatable or small. For patients with nonfloatable stones, dissolution is less likely and added weight should be given to the risk that more emergent surgery might result from a delay due to unsuccessful treatment. Safety of use beyond 24 months is not established. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.</IndicationAndUsage>
<Description>Chenodiol is the non-proprietary name for chenodeoxycholic acid, a naturally occurring human bile acid. It is a bitter-tasting white powder consisting of crystalline and amorphous particles freely soluble in methanol, acetone and acetic acid and practically insoluble in water. Its chemical name is 3α, 7α-dihydroxy-5β-cholan-24-oic acid (C24H40O4), it has a molecular weight of 392.58, and its structure is shown below;. Chenodiol film-coated tablets for oral administration contain 250 mg of Chenodiol. Inactive ingredients: pregelatinized starch; silicon dioxide; microcrystalline cellulose, sodium starch glycolate; and magnesium stearate; the thin-film coating contains: opadry YS-2-7035 [consisting of methylcellulose and glycerin] and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>79739-7143-1</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (79739-7143-1) </PackageDescription>
<NDC11Code>79739-7143-01</NDC11Code>
<ProductNDC>79739-7143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ursodiol 200 Mg</ProprietaryName>
<NonProprietaryName>Usodiol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205789</ApplicationNumber>
<LabelerName>LGM PHARMA SOLUTIONS, LLC</LabelerName>
<SubstanceName>URSODIOL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid [EPC], Bile Acids and Salts [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.</IndicationAndUsage>
<Description>Ursodiol is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. Ursodiol (ursodesoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol has a molecular weight of 392.57. Its structure is shown below. Inactive Ingredients: Silicon dioxide, magnesium stearate, and corn starch. Gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains FD&C Yellow #6 and D&C Yellow #10.</Description>
</NDC>
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