{
"NDC": [
{
"NDCCode": "81298-5010-3",
"PackageDescription": "10 CARTON in 1 BOX (81298-5010-3) > 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "81298-5010-03",
"ProductNDC": "81298-5010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboprost Tromethamine",
"NonProprietaryName": "Carboprost Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20221015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214499",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "CARBOPROST TROMETHAMINE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221015",
"SamplePackage": "N",
"IndicationAndUsage": "Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: : 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. .",
"Description": "Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2β-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)- 1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM ."
},
{
"NDCCode": "81298-5010-5",
"PackageDescription": "1 CARTON in 1 BOX (81298-5010-5) > 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "81298-5010-05",
"ProductNDC": "81298-5010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carboprost Tromethamine",
"NonProprietaryName": "Carboprost Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20221015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214499",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "CARBOPROST TROMETHAMINE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221212",
"SamplePackage": "N",
"IndicationAndUsage": "Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: : 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. .",
"Description": "Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2β-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)- 1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM ."
},
{
"NDCCode": "81298-5783-3",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (81298-5783-3) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "81298-5783-03",
"ProductNDC": "81298-5783",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213543",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "81298-5785-3",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (81298-5785-3) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "81298-5785-03",
"ProductNDC": "81298-5785",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213543",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "81298-7050-3",
"PackageDescription": "2 BAG in 1 CARTON (81298-7050-3) / 100 mL in 1 BAG (81298-7050-1) ",
"NDC11Code": "81298-7050-03",
"ProductNDC": "81298-7050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Edaravone",
"NonProprietaryName": "Edaravone",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218354",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "EDARAVONE",
"StrengthNumber": "30",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240513",
"SamplePackage": "N",
"IndicationAndUsage": "Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS).",
"Description": "The active ingredient in edaravone injection is edaravone, which is a member of the substituted 2-pyrazolin-5one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. The molecular formula is C10H10N2O and the molecular weight is 174.20. The chemical structure is:. Edaravone is a white crystalline powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether. Edaravone injection is a clear, colorless liquid provided as a sterile solution. Edaravone injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further overwrapped with silicon oxide-coated polyester film secondary packaging. The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4."
},
{
"NDCCode": "81298-7620-3",
"PackageDescription": "20 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1) ",
"NDC11Code": "81298-7620-03",
"ProductNDC": "81298-7620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate Injection,",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216042",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkalinizing Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240930",
"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 C02 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 (NaHC03) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O."
},
{
"NDCCode": "81298-8550-3",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8550-3) / 50 mL in 1 VIAL, SINGLE-DOSE (81298-8550-1) ",
"NDC11Code": "81298-8550-03",
"ProductNDC": "81298-8550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin In 0.9% Sodium Chloride",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240712",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217766",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": "1",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240712",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23."
},
{
"NDCCode": "81298-8552-3",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8552-3) / 100 mL in 1 VIAL, SINGLE-DOSE (81298-8552-1) ",
"NDC11Code": "81298-8552-03",
"ProductNDC": "81298-8552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin In 0.9% Sodium Chloride",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240712",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217766",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": ".2",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240712",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23."
},
{
"NDCCode": "81298-8554-3",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8554-3) / 100 mL in 1 VIAL, SINGLE-DOSE (81298-8554-1) ",
"NDC11Code": "81298-8554-03",
"ProductNDC": "81298-8554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin In 0.9% Sodium Chloride",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240712",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217766",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": ".4",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240712",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23."
},
{
"NDCCode": "81298-8660-3",
"PackageDescription": "12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) ",
"NDC11Code": "81298-8660-03",
"ProductNDC": "81298-8660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ak-fluor",
"NonProprietaryName": "Fluorescein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240928",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022186",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "FLUORESCEIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Diagnostic Dye [EPC], Dyes [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240928",
"SamplePackage": "N",
"IndicationAndUsage": "AK-FLUOR® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.",
"Description": "AK-FLUOR (fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. Its molecular weight is 376.27. The active ingredient is represented by the chemical structure:. AK-FLUOR (500 mg/5 mL) (100 mg/mL) 10% contains: : 1 Active ingredient: fluorescein sodium (10 % w/v, 100 mg/mL), equivalent to 88.3 mg/ml of fluorescein , 2 Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. ."
},
{
"NDCCode": "81298-9655-3",
"PackageDescription": "10 POUCH in 1 BOX (81298-9655-3) / 1 BAG in 1 POUCH (81298-9655-1) / 250 mL in 1 BAG",
"NDC11Code": "81298-9655-03",
"ProductNDC": "81298-9655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214628",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "32",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240202",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5."
},
{
"NDCCode": "81298-9658-3",
"PackageDescription": "10 POUCH in 1 BOX (81298-9658-3) / 1 BAG in 1 POUCH (81298-9658-1) / 250 mL in 1 BAG",
"NDC11Code": "81298-9658-03",
"ProductNDC": "81298-9658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214628",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "64",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240202",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5."
},
{
"NDCCode": "81298-9659-3",
"PackageDescription": "10 POUCH in 1 BOX (81298-9659-3) / 1 BAG in 1 POUCH (81298-9659-1) / 250 mL in 1 BAG",
"NDC11Code": "81298-9659-03",
"ProductNDC": "81298-9659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norepinephrine",
"NonProprietaryName": "Norepinephrine Bitartrate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214628",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "NOREPINEPHRINE BITARTRATE",
"StrengthNumber": "16",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Catecholamine [EPC], Catecholamines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240202",
"SamplePackage": "N",
"IndicationAndUsage": "Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.",
"Description": "Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5."
},
{
"NDCCode": "0363-5010-05",
"PackageDescription": "3 BOTTLE, SPRAY in 1 CARTON (0363-5010-05) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "00363-5010-05",
"ProductNDC": "0363-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208150",
"LabelerName": "Walgreens",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2020-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N"
},
{
"NDCCode": "0924-5010-00",
"PackageDescription": "3.5 g in 1 PACKET (0924-5010-00) ",
"NDC11Code": "00924-5010-00",
"ProductNDC": "0924-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Burn",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Acme United Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves pain associated with minor burns."
},
{
"NDCCode": "0924-5010-01",
"PackageDescription": "6 PACKET in 1 CARTON (0924-5010-01) / 3.5 g in 1 PACKET",
"NDC11Code": "00924-5010-01",
"ProductNDC": "0924-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Burn",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Acme United Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves pain associated with minor burns."
},
{
"NDCCode": "0924-5010-02",
"PackageDescription": "25 PACKET in 1 CARTON (0924-5010-02) / 3.5 g in 1 PACKET",
"NDC11Code": "00924-5010-02",
"ProductNDC": "0924-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Only Burn",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Acme United Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200102",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves pain associated with minor burns."
},
{
"NDCCode": "10267-5010-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (10267-5010-3) ",
"NDC11Code": "10267-5010-03",
"ProductNDC": "10267-5010",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20170504",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Contract Pharmacal Corp.",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-09-09",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20-JUN-17"
},
{
"NDCCode": "51460-5010-3",
"PackageDescription": "24 g in 1 TUBE (51460-5010-3)",
"NDC11Code": "51460-5010-03",
"ProductNDC": "51460-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amerfresh Clear",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "19960101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Amercare Products Inc",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".22",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "67835-5010-2",
"PackageDescription": "1 BAG in 1 DRUM (67835-5010-2) > 3 kg in 1 BAG",
"NDC11Code": "67835-5010-02",
"ProductNDC": "67835-5010",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SMS Pharmaceuticals Limited",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2018-05-11",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67835-5010-3",
"PackageDescription": "1 BAG in 1 DRUM (67835-5010-3) > 10 kg in 1 BAG",
"NDC11Code": "67835-5010-03",
"ProductNDC": "67835-5010",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080213",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SMS Pharmaceuticals Limited",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2018-05-11",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0409-5010-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5010-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5010-01) ",
"NDC11Code": "00409-5010-25",
"ProductNDC": "0409-5010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Marcaine",
"NonProprietaryName": "Bupivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20250203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016964",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "BUPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250203",
"SamplePackage": "N",
"IndicationAndUsage": "MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].",
"Description": "MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008."
},
{
"NDCCode": "54868-5010-0",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5010-0)",
"NDC11Code": "54868-5010-00",
"ProductNDC": "54868-5010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wellbutrin Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040302",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021515",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "DESCRIPTION. WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. WELLBUTRIN XL is supplied for oral administration as 150-mg and 300-mg, creamy-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethylcellulose aqueous dispersion,glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces."
},
{
"NDCCode": "54868-5010-1",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5010-1)",
"NDC11Code": "54868-5010-01",
"ProductNDC": "54868-5010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wellbutrin Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040302",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021515",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
"Description": "DESCRIPTION. WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. WELLBUTRIN XL is supplied for oral administration as 150-mg and 300-mg, creamy-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethylcellulose aqueous dispersion,glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces."
},
{
"NDCCode": "56152-5010-1",
"PackageDescription": "60 mL in 1 TUBE (56152-5010-1) ",
"NDC11Code": "56152-5010-01",
"ProductNDC": "56152-5010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nexgen Sunscreen Broad Spectrum Spf 36",
"ProprietaryNameSuffix": "Doc Martins",
"NonProprietaryName": "Octinoxate, Oxybenzone, Octocrylene, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170321",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cosmetic Enterprises Ltd.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 7; 4; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170321",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "81298-2390-1",
"PackageDescription": "1 VIAL in 1 CARTON (81298-2390-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "81298-2390-01",
"ProductNDC": "81298-2390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalbavancin",
"NonProprietaryName": "Dalbavancin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218602",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260303",
"SamplePackage": "N",
"IndicationAndUsage": "Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).",
"Description": "Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below). The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for intravenous infusion [see Dosage and Administration (2.4), How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "81298-3890-1",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "81298-3890-01",
"ProductNDC": "81298-3890",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eribulin Mesylate",
"NonProprietaryName": "Eribulin Mesylate",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214850",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "ERIBULIN MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240722",
"SamplePackage": "N",
"IndicationAndUsage": "Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: : 1 Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1) , 2 Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2) .",
"Description": "Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-,(2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR, 13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula:. Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment."
},
{
"NDCCode": "81298-5781-5",
"PackageDescription": "25 VIAL, SINGLE-USE in 1 CARTON (81298-5781-5) / 1 mL in 1 VIAL, SINGLE-USE (81298-5781-1) ",
"NDC11Code": "81298-5781-05",
"ProductNDC": "81298-5781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRA-ARTERIAL; INTRAMUSCULAR",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213543",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220502",
"SamplePackage": "N",
"IndicationAndUsage": "Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "81298-7500-1",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS",
"NDC11Code": "81298-7500-01",
"ProductNDC": "81298-7500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208306",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250628",
"SamplePackage": "N",
"IndicationAndUsage": "Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.",
"Description": "Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula:. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5."
},
{
"NDCCode": "81298-8110-1",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (81298-8110-1) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "81298-8110-01",
"ProductNDC": "81298-8110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclophosphamide",
"NonProprietaryName": "Cyclophosphamide",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215089",
"LabelerName": "Long Grove Pharmaceuticals, LLC",
"SubstanceName": "CYCLOPHOSPHAMIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1) , 2 Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2) .",
"Description": "Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C 7H 15Cl 2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials, ready to be reconstituted into solutions for intravenous use. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide."
}
]
}
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<NDCList>
<NDC>
<NDCCode>81298-5010-3</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (81298-5010-3) > 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>81298-5010-03</NDC11Code>
<ProductNDC>81298-5010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboprost Tromethamine</ProprietaryName>
<NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20221015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214499</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: : 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. .</IndicationAndUsage>
<Description>Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2β-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)- 1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM .</Description>
</NDC>
<NDC>
<NDCCode>81298-5010-5</NDCCode>
<PackageDescription>1 CARTON in 1 BOX (81298-5010-5) > 1 VIAL, SINGLE-DOSE in 1 CARTON (81298-5010-1) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>81298-5010-05</NDC11Code>
<ProductNDC>81298-5010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carboprost Tromethamine</ProprietaryName>
<NonProprietaryName>Carboprost Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20221015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214499</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CARBOPROST TROMETHAMINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: : 1 Failure of expulsion of the fetus during the course of treatment by another method; , 2 Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; , 3 Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; , 4 Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. .</IndicationAndUsage>
<Description>Carboprost tromethamine injection, USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: : 1 (15S)-15-methyl prostaglandin F2α tromethamine salt , 2 7-(3α,5α-dihydroxy-2β-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)- 1,3-propanediol , 3 (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt , 4 (15S)-15-methyl PGF2α-THAM .</Description>
</NDC>
<NDC>
<NDCCode>81298-5783-3</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (81298-5783-3) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>81298-5783-03</NDC11Code>
<ProductNDC>81298-5783</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213543</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>81298-5785-3</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (81298-5785-3) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>81298-5785-03</NDC11Code>
<ProductNDC>81298-5785</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213543</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>81298-7050-3</NDCCode>
<PackageDescription>2 BAG in 1 CARTON (81298-7050-3) / 100 mL in 1 BAG (81298-7050-1) </PackageDescription>
<NDC11Code>81298-7050-03</NDC11Code>
<ProductNDC>81298-7050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Edaravone</ProprietaryName>
<NonProprietaryName>Edaravone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218354</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>EDARAVONE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS).</IndicationAndUsage>
<Description>The active ingredient in edaravone injection is edaravone, which is a member of the substituted 2-pyrazolin-5one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. The molecular formula is C10H10N2O and the molecular weight is 174.20. The chemical structure is:. Edaravone is a white crystalline powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether. Edaravone injection is a clear, colorless liquid provided as a sterile solution. Edaravone injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further overwrapped with silicon oxide-coated polyester film secondary packaging. The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4.</Description>
</NDC>
<NDC>
<NDCCode>81298-7620-3</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1) </PackageDescription>
<NDC11Code>81298-7620-03</NDC11Code>
<ProductNDC>81298-7620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate Injection,</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216042</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkalinizing Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240930</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 C02 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 (NaHC03) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%. See table in HOW SUPPLIED section for contents and characteristics. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded. Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+ and HCO3-. Sodium Bicarbonate, USP is chemically designated NaHCO3, a white crystalline powder soluble in water. Water for Injection, USP is chemically designated H2O.</Description>
</NDC>
<NDC>
<NDCCode>81298-8550-3</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8550-3) / 50 mL in 1 VIAL, SINGLE-DOSE (81298-8550-1) </PackageDescription>
<NDC11Code>81298-8550-03</NDC11Code>
<ProductNDC>81298-8550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin In 0.9% Sodium Chloride</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240712</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217766</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23.</Description>
</NDC>
<NDC>
<NDCCode>81298-8552-3</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8552-3) / 100 mL in 1 VIAL, SINGLE-DOSE (81298-8552-1) </PackageDescription>
<NDC11Code>81298-8552-03</NDC11Code>
<ProductNDC>81298-8552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin In 0.9% Sodium Chloride</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240712</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217766</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23.</Description>
</NDC>
<NDC>
<NDCCode>81298-8554-3</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (81298-8554-3) / 100 mL in 1 VIAL, SINGLE-DOSE (81298-8554-1) </PackageDescription>
<NDC11Code>81298-8554-03</NDC11Code>
<ProductNDC>81298-8554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin In 0.9% Sodium Chloride</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240712</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217766</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is:. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23.</Description>
</NDC>
<NDC>
<NDCCode>81298-8660-3</NDCCode>
<PackageDescription>12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) </PackageDescription>
<NDC11Code>81298-8660-03</NDC11Code>
<ProductNDC>81298-8660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ak-fluor</ProprietaryName>
<NonProprietaryName>Fluorescein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240928</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022186</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FLUORESCEIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Diagnostic Dye [EPC], Dyes [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AK-FLUOR® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.</IndicationAndUsage>
<Description>AK-FLUOR (fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. Its molecular weight is 376.27. The active ingredient is represented by the chemical structure:. AK-FLUOR (500 mg/5 mL) (100 mg/mL) 10% contains: : 1 Active ingredient: fluorescein sodium (10 % w/v, 100 mg/mL), equivalent to 88.3 mg/ml of fluorescein , 2 Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. .</Description>
</NDC>
<NDC>
<NDCCode>81298-9655-3</NDCCode>
<PackageDescription>10 POUCH in 1 BOX (81298-9655-3) / 1 BAG in 1 POUCH (81298-9655-1) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>81298-9655-03</NDC11Code>
<ProductNDC>81298-9655</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214628</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>81298-9658-3</NDCCode>
<PackageDescription>10 POUCH in 1 BOX (81298-9658-3) / 1 BAG in 1 POUCH (81298-9658-1) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>81298-9658-03</NDC11Code>
<ProductNDC>81298-9658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214628</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>64</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>81298-9659-3</NDCCode>
<PackageDescription>10 POUCH in 1 BOX (81298-9659-3) / 1 BAG in 1 POUCH (81298-9659-1) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>81298-9659-03</NDC11Code>
<ProductNDC>81298-9659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norepinephrine</ProprietaryName>
<NonProprietaryName>Norepinephrine Bitartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214628</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NOREPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC], Catecholamines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norepinephrine in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.</IndicationAndUsage>
<Description>Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a catecholamine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Chemically, Norepinephrine Bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula:. Norepinephrine in Sodium Chloride Injection is a clear, colorless, single dose sterile solution supplied as a ready-to-use intravenous infusion bag for intravenous use and does not require further dilution. Each mL contains the equivalent of 16 or 32 or 64 micrograms of norepinephrine base supplied as 31.90 or 63.80 or 127.6 micrograms per mL of norepinephrine bitartrate monohydrate. In addition, each mL of solution contains 0.01 mg edetate disodium dihydrate as a metal chelator and 9.0 mg sodium chloride for isotonicity. It has a pH of 3.5 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0363-5010-05</NDCCode>
<PackageDescription>3 BOTTLE, SPRAY in 1 CARTON (0363-5010-05) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>00363-5010-05</NDC11Code>
<ProductNDC>0363-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208150</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0924-5010-00</NDCCode>
<PackageDescription>3.5 g in 1 PACKET (0924-5010-00) </PackageDescription>
<NDC11Code>00924-5010-00</NDC11Code>
<ProductNDC>0924-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Burn</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Acme United Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves pain associated with minor burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5010-01</NDCCode>
<PackageDescription>6 PACKET in 1 CARTON (0924-5010-01) / 3.5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5010-01</NDC11Code>
<ProductNDC>0924-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Burn</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Acme United Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves pain associated with minor burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5010-02</NDCCode>
<PackageDescription>25 PACKET in 1 CARTON (0924-5010-02) / 3.5 g in 1 PACKET</PackageDescription>
<NDC11Code>00924-5010-02</NDC11Code>
<ProductNDC>0924-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>First Aid Only Burn</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Acme United Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves pain associated with minor burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10267-5010-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (10267-5010-3) </PackageDescription>
<NDC11Code>10267-5010-03</NDC11Code>
<ProductNDC>10267-5010</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20170504</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Contract Pharmacal Corp.</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-09</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-JUN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51460-5010-3</NDCCode>
<PackageDescription>24 g in 1 TUBE (51460-5010-3)</PackageDescription>
<NDC11Code>51460-5010-03</NDC11Code>
<ProductNDC>51460-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amerfresh Clear</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>19960101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Amercare Products Inc</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.22</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67835-5010-2</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (67835-5010-2) > 3 kg in 1 BAG</PackageDescription>
<NDC11Code>67835-5010-02</NDC11Code>
<ProductNDC>67835-5010</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SMS Pharmaceuticals Limited</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-05-11</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67835-5010-3</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (67835-5010-3) > 10 kg in 1 BAG</PackageDescription>
<NDC11Code>67835-5010-03</NDC11Code>
<ProductNDC>67835-5010</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080213</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SMS Pharmaceuticals Limited</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-05-11</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-5010-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5010-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5010-01) </PackageDescription>
<NDC11Code>00409-5010-25</NDC11Code>
<ProductNDC>0409-5010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Marcaine</ProprietaryName>
<NonProprietaryName>Bupivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20250203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016964</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4)]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula. MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula. MARCAINE (bupivacaine hydrochloride) is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. MARCAINE with epinephrine 1:200,000 (as bitartrate) is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), and 0.0091 mg epinephrine bitartrate (equivalent to 0.005 mg of epinephrine), with sodium chloride for isotonicity, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.</Description>
</NDC>
<NDC>
<NDCCode>54868-5010-0</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5010-0)</PackageDescription>
<NDC11Code>54868-5010-00</NDC11Code>
<ProductNDC>54868-5010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wellbutrin Xl</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040302</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021515</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>DESCRIPTION. WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. WELLBUTRIN XL is supplied for oral administration as 150-mg and 300-mg, creamy-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethylcellulose aqueous dispersion,glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.</Description>
</NDC>
<NDC>
<NDCCode>54868-5010-1</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5010-1)</PackageDescription>
<NDC11Code>54868-5010-01</NDC11Code>
<ProductNDC>54868-5010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wellbutrin Xl</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040302</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021515</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>DESCRIPTION. WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. WELLBUTRIN XL is supplied for oral administration as 150-mg and 300-mg, creamy-white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethylcellulose aqueous dispersion,glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.</Description>
</NDC>
<NDC>
<NDCCode>56152-5010-1</NDCCode>
<PackageDescription>60 mL in 1 TUBE (56152-5010-1) </PackageDescription>
<NDC11Code>56152-5010-01</NDC11Code>
<ProductNDC>56152-5010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nexgen Sunscreen Broad Spectrum Spf 36</ProprietaryName>
<ProprietaryNameSuffix>Doc Martins</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Oxybenzone, Octocrylene, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cosmetic Enterprises Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 7; 4; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81298-2390-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (81298-2390-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>81298-2390-01</NDC11Code>
<ProductNDC>81298-2390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dalbavancin</ProprietaryName>
<NonProprietaryName>Dalbavancin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218602</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DALBAVANCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. (1.1). To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2).</IndicationAndUsage>
<Description>Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below). The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for intravenous infusion [see Dosage and Administration (2.4), How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>81298-3890-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>81298-3890-01</NDC11Code>
<ProductNDC>81298-3890</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eribulin Mesylate</ProprietaryName>
<NonProprietaryName>Eribulin Mesylate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214850</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ERIBULIN MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: : 1 Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1) , 2 Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. (1.2) .</IndicationAndUsage>
<Description>Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai. The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-,(2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR, 13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11CH4O3S. Eribulin mesylate has the following structural formula:. Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>81298-5781-5</NDCCode>
<PackageDescription>25 VIAL, SINGLE-USE in 1 CARTON (81298-5781-5) / 1 mL in 1 VIAL, SINGLE-USE (81298-5781-1) </PackageDescription>
<NDC11Code>81298-5781-05</NDC11Code>
<ProductNDC>81298-5781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRAMUSCULAR</RouteName>
<StartMarketingDate>20220502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213543</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows:. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β, 16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:. MW 434.50. Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>81298-7500-1</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>81298-7500-01</NDC11Code>
<ProductNDC>81298-7500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208306</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, and misuse overdose, and death, which can occur at any dosage or duration (see WARNINGS), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Methadone Hydrochloride Injection is not indicated as an as-needed (prn) analgesic. For use in temporary treatment of opioid dependence in patients unable to take oral medication.Limitations of UseInjectable methadone products are not approved for the outpatient treatment of opioid dependence. In this patient population, parenteral methadone is to be used only for patients unable to take oral medication, such as hospitalized patients.</IndicationAndUsage>
<Description>Methadone Hydrochloride Injection USP, 10 mg/mL is an opioid analgesic for parenteral use (intravenous, intramuscular or subcutaneous use). Methadone Hydrochloride Injection USP, 10 mg/mL contains methadone hydrochloride as the active pharmaceutical ingredient. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NOHCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. Methadone hydrochloride has the following structural formula:. Methadone Hydrochloride Injection is a sterile injectable solution available in 20 mL multiple-dose vials. Each mL of the Methadone Hydrochloride Injection contains: 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone free base), 5 mg of chlorobutanol, as a preservative, 9 mg of sodium chloride, as tonicity agent, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. The pH of the sterile injectable solution is between 3.0 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>81298-8110-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (81298-8110-1) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>81298-8110-01</NDC11Code>
<ProductNDC>81298-8110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclophosphamide</ProprietaryName>
<NonProprietaryName>Cyclophosphamide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215089</ApplicationNumber>
<LabelerName>Long Grove Pharmaceuticals, LLC</LabelerName>
<SubstanceName>CYCLOPHOSPHAMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclophosphamide is an alkylating drug indicated for treatment of: 1 Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1) , 2 Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2) .</IndicationAndUsage>
<Description>Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula. Cyclophosphamide is a white crystalline powder with the molecular formula C 7H 15Cl 2N 2O 2PH 2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials, ready to be reconstituted into solutions for intravenous use. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide.</Description>
</NDC>
</NDCList>