{
"NDC": [
{
"NDCCode": "72888-502-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-02) ",
"NDC11Code": "72888-0502-02",
"ProductNDC": "72888-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-502-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-01) ",
"NDC11Code": "72888-0502-01",
"ProductNDC": "72888-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-502-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-03) ",
"NDC11Code": "72888-0502-03",
"ProductNDC": "72888-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-038-02",
"PackageDescription": "118 mL in 1 BOTTLE (72888-038-02) ",
"NDC11Code": "72888-0038-02",
"ProductNDC": "72888-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220869",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260623",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.7 and 5.2. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid monohydrate, menthol, orange flavour, propylene glycol, saccharin sodium, sodium benzoate, sucrose, trisodium citrate dihydrate and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10 H-Phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula:. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C 18H 25NOHBrH 2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line)."
},
{
"NDCCode": "72888-040-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (72888-040-02) ",
"NDC11Code": "72888-0040-02",
"ProductNDC": "72888-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone And Hydrochlorothiazide",
"NonProprietaryName": "Spironolactone And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220884",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "SPIRONOLACTONE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautionssection). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for. Edematous conditionsfor patients with:. Congestive heart failure. : 1 For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures;, 2 The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate;, 3 The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.",
"Description": "Spironolactone and hydrochlorothiazide oral tablets, USP contain. spironolactone………………..25 mg. hydrochlorothiazide………….25 mg. Spironolactone, an aldosterone antagonist, is 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Inactive ingredients include calcium sulfate dihydrate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, maize starch, peppermint flavor, polyethylene glycol, povidone, and titanium dioxide. The peppermint flavor contains maltodextrin, modified corn starch and natural flavors."
},
{
"NDCCode": "72888-197-02",
"PackageDescription": "6 BOTTLE in 1 CARTON (72888-197-02) / 30 TABLET in 1 BOTTLE (72888-197-30) ",
"NDC11Code": "72888-0197-02",
"ProductNDC": "72888-197",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA218698",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"Description": "Metoprolol Tartrate Tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol Tartrate Tablets is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide."
},
{
"NDCCode": "72888-208-02",
"PackageDescription": "10000 TABLET in 1 POUCH (72888-208-02) ",
"NDC11Code": "72888-0208-02",
"ProductNDC": "72888-208",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250726",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: Tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate."
},
{
"NDCCode": "72888-210-02",
"PackageDescription": "5000 TABLET in 1 POUCH (72888-210-02) ",
"NDC11Code": "72888-0210-02",
"ProductNDC": "72888-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250726",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: Tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate."
},
{
"NDCCode": "72888-248-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (72888-248-02) / 72 SPRAY in 1 BOTTLE",
"NDC11Code": "72888-0248-02",
"ProductNDC": "72888-248",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fluticasone Propionate",
"NonProprietaryName": "Fluticasone Propionate Nasal",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20250815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219060",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260706",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy, watery eyes, 3 itchy nose, 4 runny nose, 5 sneezing."
},
{
"NDCCode": "72888-268-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (72888-268-02) ",
"NDC11Code": "72888-0268-02",
"ProductNDC": "72888-268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentoxifylline",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018631",
"LabelerName": "Advagen Pharma Ltd.,",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Pentoxifylline extended-release tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablet can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.",
"Description": "Pentoxifylline extended-release tablets for oral administration contain 400 mg of the active drug and the following inactive ingredients: FD&C Red No. 3, hydroxyethyl cellulose USP, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7 dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is 6493-05-6. The chemical structure is."
},
{
"NDCCode": "72888-271-02",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72888-271-02) ",
"NDC11Code": "72888-0271-02",
"ProductNDC": "72888-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203332",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260727",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 Panic Disorder (PD) [see Clinical Studies (14.4)] .",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, 100 mg or 150 mg venlafaxine. Inactive ingredients consist of ethylcellulose, hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&C red no. 3 and FD&C yellow no. 6. The 100 mg capsules also contain iron oxide red. The 150 mg capsules also contain iron oxide red and iron oxide yellow. The 37.5 mg, 75 mg, 100 mg and 150 mg capsules are imprinted with black and grey ink which contains iron black oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide. Venlafaxine Hydrochloride Extended-release Capsules, USP meets USP Dissolution Test 11."
},
{
"NDCCode": "72888-460-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (72888-460-02) ",
"NDC11Code": "72888-0460-02",
"ProductNDC": "72888-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207717",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow."
},
{
"NDCCode": "72888-461-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (72888-461-02) ",
"NDC11Code": "72888-0461-02",
"ProductNDC": "72888-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207717",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow."
},
{
"NDCCode": "72888-462-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (72888-462-02) ",
"NDC11Code": "72888-0462-02",
"ProductNDC": "72888-462",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207717",
"LabelerName": "Advagen Pharma Ltd.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow."
},
{
"NDCCode": "72888-466-02",
"PackageDescription": "237 mL in 1 BOTTLE (72888-466-02) ",
"NDC11Code": "72888-0466-02",
"ProductNDC": "72888-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214445",
"LabelerName": "Advagen Pharma Ltd.,",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250603",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.",
"Description": "Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12ClNO 2. Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral solution inactive ingredients are: glycerin, methyl paraben, propyl paraben, sucralose, sodium carboxymethylcellulose, grape flavor, hydrochloride acid, sodium hydroxide, purified water."
},
{
"NDCCode": "72888-468-02",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02) ",
"NDC11Code": "72888-0468-02",
"ProductNDC": "72888-468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211953",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250520",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas)."
},
{
"NDCCode": "72888-497-02",
"PackageDescription": "100 TABLET in 1 BOTTLE (72888-497-02) ",
"NDC11Code": "72888-0497-02",
"ProductNDC": "72888-497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075468",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260612",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders. Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS:Loss of Effect). Panic Disorder. Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ, Λ and Λ containing 0.25 mg, 1 mg or 2 mg of clonazepam respectively. 66 L3 67 69 Each tablet also contains lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate with the following colourants: 0.25 mg-D & C Yellow 10 Al Lake, 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:."
},
{
"NDCCode": "72888-499-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-499-02) ",
"NDC11Code": "72888-0499-02",
"ProductNDC": "72888-499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "3.125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-500-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-500-02) ",
"NDC11Code": "72888-0500-02",
"ProductNDC": "72888-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-501-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-02) ",
"NDC11Code": "72888-0501-02",
"ProductNDC": "72888-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078786",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250917",
"SamplePackage": "N",
"Description": "Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5)."
},
{
"NDCCode": "72888-509-02",
"PackageDescription": "90 TABLET in 1 BOTTLE (72888-509-02) ",
"NDC11Code": "72888-0509-02",
"ProductNDC": "72888-509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Hydrochloride",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20150610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090279",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260710",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are a white to off white round convex, tablet debossed with ˄ on 2 mg, ˄ on 8 mg on one side and plain on the B9 B10. other side, debossed with 24 on one side and ˄ on other side of 4 mg, debossed with L52 on one side and ˄ on other side of 12 mg. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in four dosage strengths, buprenorphine 2 mg, buprenorphine 4 mg, buprenorphine 8 mg and buprenorphine 12 mg (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP, 4.3 mg buprenorphine hydrochloride USP, 8.64 mg buprenorphine hydrochloride USP and 12.96 mg buprenorphine hydrochloride USP). Each tablet also contains lactose monohydrate, mannitol, corn starch, citric acid anhydrous, sodium citrate dihydrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan -2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4∙HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane."
},
{
"NDCCode": "72888-510-02",
"PackageDescription": "90 TABLET in 1 BOTTLE (72888-510-02) ",
"NDC11Code": "72888-0510-02",
"ProductNDC": "72888-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine Hydrochloride",
"NonProprietaryName": "Buprenorphine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20260201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090279",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260710",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are a white to off white round convex, tablet debossed with ˄ on 2 mg, ˄ on 8 mg on one side and plain on the B9 B10. other side, debossed with 24 on one side and ˄ on other side of 4 mg, debossed with L52 on one side and ˄ on other side of 12 mg. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in four dosage strengths, buprenorphine 2 mg, buprenorphine 4 mg, buprenorphine 8 mg and buprenorphine 12 mg (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP, 4.3 mg buprenorphine hydrochloride USP, 8.64 mg buprenorphine hydrochloride USP and 12.96 mg buprenorphine hydrochloride USP). Each tablet also contains lactose monohydrate, mannitol, corn starch, citric acid anhydrous, sodium citrate dihydrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan -2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4∙HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane."
},
{
"NDCCode": "13533-502-01",
"PackageDescription": "1 KIT in 1 CARTON (13533-502-01) * 50 mL in 1 VIAL, GLASS (13533-503-02) * 50 mL in 1 VIAL, GLASS (13533-200-50) ",
"NDC11Code": "13533-0502-01",
"ProductNDC": "13533-502",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Fesilty",
"NonProprietaryName": "Fibrinogen, Human-chmt",
"DosageFormName": "KIT",
"StartMarketingDate": "20251216",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125833",
"LabelerName": "Grifols USA LLC",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251216",
"SamplePackage": "N",
"IndicationAndUsage": "FESILTY is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.Limitations of Use: FESILTY is not indicated for dysfibrinogenemia.",
"Description": "FESILTY (fibrinogen, human – chmt), is a purified, sterile, non-pyrogenic, lyophilized powder of human fibrinogen for reconstitution for intravenous administration. Human fibrinogen is purified from Source Plasma from the cryoprecipitate fraction and processed using a combination of aluminum hydroxide purification, solvent/detergent (S/D) treatment, anion and cation exchange chromatography, glycine precipitation, and Ultraviolet (UV)-C irradiation. FESILTY is supplied in a single-dose vial containing nominally 1 gram of fibrinogen. The actual amount of fibrinogen is printed on the vial label and carton in milligrams fibrinogen per vial. When reconstituted with 50 mL sterile water for injection, FESILTY contains approximately 20 mg/mL protein, of which not less than 80% is fibrinogen monomer. Each vial of FESILTY also contains 421.3 mg arginine hydrochloride, 292.2 mg sodium chloride, 73.5 mg sodium citrate dihydrate, 25.5 mg polysorbate 80, and 567.5 mg trehalose dihydrate. FESILTY has a pH of 6.5 to 7.5 and an osmolality of ≥ 240 mOsmol/kg. FESILTY does not contain preservatives and is not made with natural rubber latex.FESILTY is prepared from pooled Source Plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of FESILTY is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA, and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 104 IU/mL in the manufacturing pool.The manufacturing process for FESILTY employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include S/D treatment, UV-C irradiation, and heat treatment of lyophilized fibrinogen. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. The manufacturing process was also investigated for its capacity to reduce the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant, vCJD. One chromatographic purification step has been shown to reduce TSE infectivity of an experimental model agent. These studies provide reasonable assurance that low levels (at least 3.27 log10) of vCJD/CJD agent infectivity, if present in the starting material, would be removed."
},
{
"NDCCode": "13537-502-02",
"PackageDescription": "1 CARTRIDGE in 1 BOX (13537-502-02) > 10 g in 1 CARTRIDGE (13537-502-01)",
"NDC11Code": "13537-0502-02",
"ProductNDC": "13537-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Dorado/double Use Compact Spf 15 Gold Deluxe Edition Medium 6",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide, And Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
"StrengthNumber": ".062393; .049; .03",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "14141-502-02",
"PackageDescription": "1 CARTRIDGE in 1 BOX (14141-502-02) > 10 g in 1 CARTRIDGE (14141-502-01) ",
"NDC11Code": "14141-0502-02",
"ProductNDC": "14141-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel",
"ProprietaryNameSuffix": "Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Dorado/double Use Compact Spf 15 Gold Deluxe Edition Medium 6",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide, And Octinoxate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE",
"StrengthNumber": ".0624; .049; .03",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130527",
"SamplePackage": "N"
},
{
"NDCCode": "16714-502-02",
"PackageDescription": "1 TUBE in 1 CARTON (16714-502-02) > 30 g in 1 TUBE",
"NDC11Code": "16714-0502-02",
"ProductNDC": "16714-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075008",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "17271-502-02",
"PackageDescription": "6 BOTTLE in 1 BOX (17271-502-02) > 946 mL in 1 BOTTLE",
"NDC11Code": "17271-0502-02",
"ProductNDC": "17271-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bd E-z Scrub",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Becton, Dickinson and Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20000401",
"SamplePackage": "N"
},
{
"NDCCode": "41520-502-02",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (41520-502-02)",
"NDC11Code": "41520-0502-02",
"ProductNDC": "41520-502",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone",
"ProprietaryNameSuffix": "Antibacterial Hand Sanitizer Festival Of Lights",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140814",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AMERICAN SALES COMPANY",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "650",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "44567-502-90",
"PackageDescription": "10 BAG in 1 CARTON (44567-502-90) / 100 mL in 1 BAG (44567-502-02) ",
"NDC11Code": "44567-0502-90",
"ProductNDC": "44567-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202543",
"LabelerName": "WG Critical Care, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3) .",
"Description": "Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1000 mg/100 mL: One 100 mL bag contains 1000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate."
},
{
"NDCCode": "47426-502-02",
"PackageDescription": "1 CARTON in 1 KIT (47426-502-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-502-04) / 10.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47426-0502-02",
"ProductNDC": "47426-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zynrelef",
"NonProprietaryName": "Bupivacaine And Meloxicam",
"DosageFormName": "SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211988",
"LabelerName": "Heron Therapeutics, Inc.",
"SubstanceName": "BUPIVACAINE; MELOXICAM",
"StrengthNumber": "300; 9",
"StrengthUnit": "mg/10.5mL; mg/10.5mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: 1 soft tissue surgical procedures, 2 orthopedic surgical procedures–foot and ankle procedures–other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10)].",
"Description": "ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use, contains bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72888-502-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-02) </PackageDescription>
<NDC11Code>72888-0502-02</NDC11Code>
<ProductNDC>72888-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-502-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-01) </PackageDescription>
<NDC11Code>72888-0502-01</NDC11Code>
<ProductNDC>72888-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-502-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-502-03) </PackageDescription>
<NDC11Code>72888-0502-03</NDC11Code>
<ProductNDC>72888-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-038-02</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (72888-038-02) </PackageDescription>
<NDC11Code>72888-0038-02</NDC11Code>
<ProductNDC>72888-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220869</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>6.25; 15</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.7 and 5.2. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid monohydrate, menthol, orange flavour, propylene glycol, saccharin sodium, sodium benzoate, sucrose, trisodium citrate dihydrate and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10 H-Phenothiazine-10-ethanamine, N, N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula:. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C 18H 25NOHBrH 2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line).</Description>
</NDC>
<NDC>
<NDCCode>72888-040-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72888-040-02) </PackageDescription>
<NDC11Code>72888-0040-02</NDC11Code>
<ProductNDC>72888-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Spironolactone And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220884</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>SPIRONOLACTONE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautionssection). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for. Edematous conditionsfor patients with:. Congestive heart failure. : 1 For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures;, 2 The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate;, 3 The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.</IndicationAndUsage>
<Description>Spironolactone and hydrochlorothiazide oral tablets, USP contain. spironolactone………………..25 mg. hydrochlorothiazide………….25 mg. Spironolactone, an aldosterone antagonist, is 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-Chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Inactive ingredients include calcium sulfate dihydrate, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, maize starch, peppermint flavor, polyethylene glycol, povidone, and titanium dioxide. The peppermint flavor contains maltodextrin, modified corn starch and natural flavors.</Description>
</NDC>
<NDC>
<NDCCode>72888-197-02</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (72888-197-02) / 30 TABLET in 1 BOTTLE (72888-197-30) </PackageDescription>
<NDC11Code>72888-0197-02</NDC11Code>
<ProductNDC>72888-197</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA218698</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol Tartrate Tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol Tartrate Tablets is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72888-208-02</NDCCode>
<PackageDescription>10000 TABLET in 1 POUCH (72888-208-02) </PackageDescription>
<NDC11Code>72888-0208-02</NDC11Code>
<ProductNDC>72888-208</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: Tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-210-02</NDCCode>
<PackageDescription>5000 TABLET in 1 POUCH (72888-210-02) </PackageDescription>
<NDC11Code>72888-0210-02</NDC11Code>
<ProductNDC>72888-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate is a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients: Tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72888-248-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72888-248-02) / 72 SPRAY in 1 BOTTLE</PackageDescription>
<NDC11Code>72888-0248-02</NDC11Code>
<ProductNDC>72888-248</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fluticasone Propionate</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate Nasal</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20250815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219060</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: 1 nasal congestion, 2 itchy, watery eyes, 3 itchy nose, 4 runny nose, 5 sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72888-268-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72888-268-02) </PackageDescription>
<NDC11Code>72888-0268-02</NDC11Code>
<ProductNDC>72888-268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentoxifylline</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261001</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018631</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.,</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentoxifylline extended-release tablet is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline extended-release tablet can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.</IndicationAndUsage>
<Description>Pentoxifylline extended-release tablets for oral administration contain 400 mg of the active drug and the following inactive ingredients: FD&C Red No. 3, hydroxyethyl cellulose USP, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7 dimethylxanthine that, unlike theophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is 6493-05-6. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>72888-271-02</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72888-271-02) </PackageDescription>
<NDC11Code>72888-0271-02</NDC11Code>
<ProductNDC>72888-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203332</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)] , 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)] , 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)] , 4 Panic Disorder (PD) [see Clinical Studies (14.4)] .</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.86. The structural formula is shown as follows:. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, 100 mg or 150 mg venlafaxine. Inactive ingredients consist of ethylcellulose, hypromellose and sugar spheres. The empty hard gelatin capsule shells contain gelatin and titanium dioxide. The 37.5 mg capsules also contain iron oxide black. The 75 mg capsules also contain FD&C red no. 3 and FD&C yellow no. 6. The 100 mg capsules also contain iron oxide red. The 150 mg capsules also contain iron oxide red and iron oxide yellow. The 37.5 mg, 75 mg, 100 mg and 150 mg capsules are imprinted with black and grey ink which contains iron black oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide. Venlafaxine Hydrochloride Extended-release Capsules, USP meets USP Dissolution Test 11.</Description>
</NDC>
<NDC>
<NDCCode>72888-460-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (72888-460-02) </PackageDescription>
<NDC11Code>72888-0460-02</NDC11Code>
<ProductNDC>72888-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207717</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72888-461-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72888-461-02) </PackageDescription>
<NDC11Code>72888-0461-02</NDC11Code>
<ProductNDC>72888-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207717</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72888-462-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (72888-462-02) </PackageDescription>
<NDC11Code>72888-0462-02</NDC11Code>
<ProductNDC>72888-462</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207717</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine tablets is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72888-466-02</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (72888-466-02) </PackageDescription>
<NDC11Code>72888-0466-02</NDC11Code>
<ProductNDC>72888-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214445</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd.,</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use. Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.</IndicationAndUsage>
<Description>Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Molecular formula is C 10H 12ClNO 2. Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral solution inactive ingredients are: glycerin, methyl paraben, propyl paraben, sucralose, sodium carboxymethylcellulose, grape flavor, hydrochloride acid, sodium hydroxide, purified water.</Description>
</NDC>
<NDC>
<NDCCode>72888-468-02</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02) </PackageDescription>
<NDC11Code>72888-0468-02</NDC11Code>
<ProductNDC>72888-468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211953</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas).</Description>
</NDC>
<NDC>
<NDCCode>72888-497-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72888-497-02) </PackageDescription>
<NDC11Code>72888-0497-02</NDC11Code>
<ProductNDC>72888-497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075468</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders. Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS:Loss of Effect). Panic Disorder. Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ, Λ and Λ containing 0.25 mg, 1 mg or 2 mg of clonazepam respectively. 66 L3 67 69 Each tablet also contains lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate with the following colourants: 0.25 mg-D & C Yellow 10 Al Lake, 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>72888-499-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-499-02) </PackageDescription>
<NDC11Code>72888-0499-02</NDC11Code>
<ProductNDC>72888-499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>3.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-500-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-500-02) </PackageDescription>
<NDC11Code>72888-0500-02</NDC11Code>
<ProductNDC>72888-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-501-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-02) </PackageDescription>
<NDC11Code>72888-0501-02</NDC11Code>
<ProductNDC>72888-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078786</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol USP is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125 mg. 6.25 mg. 12.5 mg. and 25 mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellase sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS wittlout pancreatin, pH7.5).</Description>
</NDC>
<NDC>
<NDCCode>72888-509-02</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72888-509-02) </PackageDescription>
<NDC11Code>72888-0509-02</NDC11Code>
<ProductNDC>72888-509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Hydrochloride</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20150610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090279</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are a white to off white round convex, tablet debossed with ˄ on 2 mg, ˄ on 8 mg on one side and plain on the B9 B10. other side, debossed with 24 on one side and ˄ on other side of 4 mg, debossed with L52 on one side and ˄ on other side of 12 mg. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in four dosage strengths, buprenorphine 2 mg, buprenorphine 4 mg, buprenorphine 8 mg and buprenorphine 12 mg (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP, 4.3 mg buprenorphine hydrochloride USP, 8.64 mg buprenorphine hydrochloride USP and 12.96 mg buprenorphine hydrochloride USP). Each tablet also contains lactose monohydrate, mannitol, corn starch, citric acid anhydrous, sodium citrate dihydrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan -2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4∙HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.</Description>
</NDC>
<NDC>
<NDCCode>72888-510-02</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72888-510-02) </PackageDescription>
<NDC11Code>72888-0510-02</NDC11Code>
<ProductNDC>72888-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine Hydrochloride</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20260201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090279</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are a white to off white round convex, tablet debossed with ˄ on 2 mg, ˄ on 8 mg on one side and plain on the B9 B10. other side, debossed with 24 on one side and ˄ on other side of 4 mg, debossed with L52 on one side and ˄ on other side of 12 mg. It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in four dosage strengths, buprenorphine 2 mg, buprenorphine 4 mg, buprenorphine 8 mg and buprenorphine 12 mg (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP, 4.3 mg buprenorphine hydrochloride USP, 8.64 mg buprenorphine hydrochloride USP and 12.96 mg buprenorphine hydrochloride USP). Each tablet also contains lactose monohydrate, mannitol, corn starch, citric acid anhydrous, sodium citrate dihydrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan -2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4∙HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.</Description>
</NDC>
<NDC>
<NDCCode>13533-502-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (13533-502-01) * 50 mL in 1 VIAL, GLASS (13533-503-02) * 50 mL in 1 VIAL, GLASS (13533-200-50) </PackageDescription>
<NDC11Code>13533-0502-01</NDC11Code>
<ProductNDC>13533-502</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Fesilty</ProprietaryName>
<NonProprietaryName>Fibrinogen, Human-chmt</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251216</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125833</ApplicationNumber>
<LabelerName>Grifols USA LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FESILTY is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.Limitations of Use: FESILTY is not indicated for dysfibrinogenemia.</IndicationAndUsage>
<Description>FESILTY (fibrinogen, human – chmt), is a purified, sterile, non-pyrogenic, lyophilized powder of human fibrinogen for reconstitution for intravenous administration. Human fibrinogen is purified from Source Plasma from the cryoprecipitate fraction and processed using a combination of aluminum hydroxide purification, solvent/detergent (S/D) treatment, anion and cation exchange chromatography, glycine precipitation, and Ultraviolet (UV)-C irradiation. FESILTY is supplied in a single-dose vial containing nominally 1 gram of fibrinogen. The actual amount of fibrinogen is printed on the vial label and carton in milligrams fibrinogen per vial. When reconstituted with 50 mL sterile water for injection, FESILTY contains approximately 20 mg/mL protein, of which not less than 80% is fibrinogen monomer. Each vial of FESILTY also contains 421.3 mg arginine hydrochloride, 292.2 mg sodium chloride, 73.5 mg sodium citrate dihydrate, 25.5 mg polysorbate 80, and 567.5 mg trehalose dihydrate. FESILTY has a pH of 6.5 to 7.5 and an osmolality of ≥ 240 mOsmol/kg. FESILTY does not contain preservatives and is not made with natural rubber latex.FESILTY is prepared from pooled Source Plasma obtained from healthy volunteer donors. Each plasma donation used for the manufacture of FESILTY is collected from FDA-licensed facilities. Plasma donations must test negative for hepatitis B virus (HBV) surface antigen (HBsAg), antibodies to human immunodeficiency virus (HIV) strains 1 and 2 (anti-HIV-1/2), and antibodies to the hepatitis C virus (anti-HCV) as determined by enzyme immunoassay (EIA). In addition, samples from manufacturing pools must test non-reactive for HIV RNA, HCV RNA, HBV DNA, and Hepatitis A Virus (HAV) RNA, by Nucleic Acid Amplification Testing (NAT). Parvovirus B19 (B19V) DNA is also tested by NAT and must not exceed 104 IU/mL in the manufacturing pool.The manufacturing process for FESILTY employs several steps to remove/inactivate adventitious viruses to further increase the margins of safety. These steps include S/D treatment, UV-C irradiation, and heat treatment of lyophilized fibrinogen. Virus clearance studies with a scaled-down process have been performed for these steps to determine their capacity to inactivate or remove both enveloped and non-enveloped viruses. The results are shown in Table 3. The manufacturing process was also investigated for its capacity to reduce the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered a model for CJD and its variant, vCJD. One chromatographic purification step has been shown to reduce TSE infectivity of an experimental model agent. These studies provide reasonable assurance that low levels (at least 3.27 log10) of vCJD/CJD agent infectivity, if present in the starting material, would be removed.</Description>
</NDC>
<NDC>
<NDCCode>13537-502-02</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 BOX (13537-502-02) > 10 g in 1 CARTRIDGE (13537-502-01)</PackageDescription>
<NDC11Code>13537-0502-02</NDC11Code>
<ProductNDC>13537-502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Dorado/double Use Compact Spf 15 Gold Deluxe Edition Medium 6</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.062393; .049; .03</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>14141-502-02</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 BOX (14141-502-02) > 10 g in 1 CARTRIDGE (14141-502-01) </PackageDescription>
<NDC11Code>14141-0502-02</NDC11Code>
<ProductNDC>14141-502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel</ProprietaryName>
<ProprietaryNameSuffix>Divine Polvos Compactos Doble Uso Fps 15 Edicion De Lujo Dorado/double Use Compact Spf 15 Gold Deluxe Edition Medium 6</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide, And Octinoxate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.0624; .049; .03</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-502-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16714-502-02) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>16714-0502-02</NDC11Code>
<ProductNDC>16714-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075008</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>17271-502-02</NDCCode>
<PackageDescription>6 BOTTLE in 1 BOX (17271-502-02) > 946 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>17271-0502-02</NDC11Code>
<ProductNDC>17271-502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bd E-z Scrub</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Becton, Dickinson and Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-502-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, PLASTIC (41520-502-02)</PackageDescription>
<NDC11Code>41520-0502-02</NDC11Code>
<ProductNDC>41520-502</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial Hand Sanitizer Festival Of Lights</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140814</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AMERICAN SALES COMPANY</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44567-502-90</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (44567-502-90) / 100 mL in 1 BAG (44567-502-02) </PackageDescription>
<NDC11Code>44567-0502-90</NDC11Code>
<ProductNDC>44567-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202543</ApplicationNumber>
<LabelerName>WG Critical Care, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: 1 Partial-onset seizures (1.1) , 2 Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures (1.3) .</IndicationAndUsage>
<Description>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg/100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1000 mg/100 mL: One 100 mL bag contains 1000 mg of levetiracetam (10 mg/mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate.</Description>
</NDC>
<NDC>
<NDCCode>47426-502-02</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (47426-502-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-502-04) / 10.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>47426-0502-02</NDC11Code>
<ProductNDC>47426-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zynrelef</ProprietaryName>
<NonProprietaryName>Bupivacaine And Meloxicam</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211988</ApplicationNumber>
<LabelerName>Heron Therapeutics, Inc.</LabelerName>
<SubstanceName>BUPIVACAINE; MELOXICAM</SubstanceName>
<StrengthNumber>300; 9</StrengthNumber>
<StrengthUnit>mg/10.5mL; mg/10.5mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: 1 soft tissue surgical procedures, 2 orthopedic surgical procedures–foot and ankle procedures–other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10)].</IndicationAndUsage>
<Description>ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for soft tissue or periarticular instillation use, contains bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID).</Description>
</NDC>
</NDCList>