{
"NDC": [
{
"NDCCode": "59651-542-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (59651-542-60) ",
"NDC11Code": "59651-0542-60",
"ProductNDC": "59651-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216547",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "59651-542-15",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (59651-542-15) / 15 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0542-15",
"ProductNDC": "59651-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216547",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "33261-542-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-542-60)",
"NDC11Code": "33261-0542-60",
"ProductNDC": "33261-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "33342-542-09",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (33342-542-09) ",
"NDC11Code": "33342-0542-09",
"ProductNDC": "33342-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219530",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260603",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of pediatric patients 2 years of age and older with: Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers. Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4) Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).",
"Description": "Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&C BLUE #2, FD&C BLUE #1."
},
{
"NDCCode": "43063-542-60",
"PackageDescription": "60 CAPSULE in 1 PACKAGE (43063-542-60)",
"NDC11Code": "43063-0542-60",
"ProductNDC": "43063-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062058",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43744-542-60",
"PackageDescription": "750 g in 1 DRUM (43744-542-60)",
"NDC11Code": "43744-0542-60",
"ProductNDC": "43744-542",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "45865-542-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (45865-542-60)",
"NDC11Code": "45865-0542-60",
"ProductNDC": "45865-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086988",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: povidone, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "49999-542-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49999-542-60)",
"NDC11Code": "49999-0542-60",
"ProductNDC": "49999-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentoxifylline",
"NonProprietaryName": "Pentoxifylline",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19980731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075028",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "PENTOXIFYLLINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-04-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50458-542-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) ",
"NDC11Code": "50458-0542-60",
"ProductNDC": "50458-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invokamet",
"NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204353",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "150; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140808",
"SamplePackage": "N",
"IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
"Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
},
{
"NDCCode": "51407-542-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (51407-542-60) ",
"NDC11Code": "51407-0542-60",
"ProductNDC": "51407-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208625",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240723",
"SamplePackage": "N",
"IndicationAndUsage": "Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "57483-542-03",
"PackageDescription": "3 BOTTLE in 1 CARTON (57483-542-03) / 60 mL in 1 BOTTLE",
"NDC11Code": "57483-0542-03",
"ProductNDC": "57483-542",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Regoxidine",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "Innovus Pharmaceuticals Inc.",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)."
},
{
"NDCCode": "60760-542-60",
"PackageDescription": "60 VIAL in 1 PACKAGE (60760-542-60) > 2.5 mL in 1 VIAL",
"NDC11Code": "60760-0542-60",
"ProductNDC": "60760-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20140130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "St Marys Medical Park Pharmacy",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "61649-542-01",
"PackageDescription": "60 g in 1 TUBE (61649-542-01) ",
"NDC11Code": "61649-0542-01",
"ProductNDC": "61649-542",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attitude Sunly Kids Mineral Sunscreen Stick Spf 50 Unscented",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "9055-7588 Qu�bec Inc.DBA ATTITUDE",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "24",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "62900-542-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (62900-542-60) ",
"NDC11Code": "62900-0542-60",
"ProductNDC": "62900-542",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Relorn",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200319",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "UNIPHARM, INC.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200319",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "66213-542-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (66213-542-60)",
"NDC11Code": "66213-0542-60",
"ProductNDC": "66213-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Animi-3 With Vitamin D",
"NonProprietaryName": "Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PBM Pharmaceuticals, Inc",
"SubstanceName": "FOLIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; SOY STEROL",
"StrengthNumber": "1; 1000; 12.5; 500; 500; 250; 35; 200",
"StrengthUnit": "mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Animi-3® with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.",
"Description": "Animi-3® with Vitamin D Capsules are intended for oral administration. Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols).Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water)."
},
{
"NDCCode": "68001-542-60",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (68001-542-60) / 1 mL in 1 VIAL, MULTI-DOSE (68001-542-59) ",
"NDC11Code": "68001-0542-60",
"ProductNDC": "68001-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyanocobalamin",
"NonProprietaryName": "Cyanocobalamin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20220624",
"EndMarketingDate": "20261031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080737",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "CYANOCOBALAMIN",
"StrengthNumber": "1000",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Vitamin B 12 [CS], Vitamin B12 [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220624",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N"
},
{
"NDCCode": "71205-542-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71205-542-60) ",
"NDC11Code": "71205-0542-60",
"ProductNDC": "71205-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202659",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210311",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated rounde-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "71610-542-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (71610-542-60) ",
"NDC11Code": "71610-0542-60",
"ProductNDC": "71610-542",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210513",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "59651-009-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60) ",
"NDC11Code": "59651-0009-60",
"ProductNDC": "59651-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209081",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221223",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red."
},
{
"NDCCode": "59651-010-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-010-60) ",
"NDC11Code": "59651-0010-60",
"ProductNDC": "59651-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209081",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221223",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red."
},
{
"NDCCode": "59651-042-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60) ",
"NDC11Code": "59651-0042-60",
"ProductNDC": "59651-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209694",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N"
},
{
"NDCCode": "59651-043-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-043-60) ",
"NDC11Code": "59651-0043-60",
"ProductNDC": "59651-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209694",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N"
},
{
"NDCCode": "59651-084-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60) ",
"NDC11Code": "59651-0084-60",
"ProductNDC": "59651-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210385",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221222",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is slightly soluble in methanol and highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion (which contains polymer substance based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), methacrylic acid copolymer Type A [which contains poly (methacrylic acid-co-methacrylate) 1:1 and sodium lauryl sulfate], silicified microcrystalline cellulose, talc and triethyl citrate. The empty hard gelatin capsule shell contains gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the 240 mg capsule shell contains FD&C Blue 2 and iron oxide yellow. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "59651-085-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60) ",
"NDC11Code": "59651-0085-60",
"ProductNDC": "59651-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darunavir",
"NonProprietaryName": "Darunavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210677",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DARUNAVIR PROPYLENE GLYCOLATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231128",
"SamplePackage": "N",
"IndicationAndUsage": "Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].",
"Description": "Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, (present as darunavir propylene glycolate) which has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methyl-propyl)amino]-2-hydroxy-1-(phenylmethyl)- propyl]carbamic acid (3R,3aS,6aR)-hexahydro-furo[2,3-b]furan-3-yl ester. 1,2-propanediol solvate. Its molecular formula is C27H37N3O7SC3H8O2 and its molecular weight is 623.73. Darunavir propylene glycolate has the following structural formula. Darunavir propylene glycolate is a white to off-white, slightly hygroscopic powder with a solubility of approximately 0.21 mg per mL in water at 37°C. Darunavir 600 mg tablets are available as orange colored, oval shaped, biconvex, film-coated tablets for oral administration. Each 600 mg tablet contains darunavir 600 mg (present as darunavir propylene glycolate). Darunavir 800 mg tablets are available as dark red colored, oval shaped, biconvex, film-coated tablets for oral administration. Each 800 mg tablet contains darunavir 800 mg (present as darunavir propylene glycolate). Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxyl propyl cellulose, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide. In addition, the 600 mg tablets contain FD&C Yellow#6/Sunset Yellow FCF aluminum lake. The 800 mg tablets contain iron oxide red. All strengths for darunavir tablets are expressed in terms of the free form of darunavir."
},
{
"NDCCode": "59651-118-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-118-60) ",
"NDC11Code": "59651-0118-60",
"ProductNDC": "59651-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210740",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190122",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "59651-119-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-119-60) ",
"NDC11Code": "59651-0119-60",
"ProductNDC": "59651-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210740",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190122",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "59651-120-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-120-60) ",
"NDC11Code": "59651-0120-60",
"ProductNDC": "59651-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210740",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190122",
"SamplePackage": "N",
"IndicationAndUsage": "Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "59651-144-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (59651-144-60) ",
"NDC11Code": "59651-0144-60",
"ProductNDC": "59651-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211058",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180716",
"SamplePackage": "N"
},
{
"NDCCode": "59651-155-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-60) ",
"NDC11Code": "59651-0155-60",
"ProductNDC": "59651-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211489",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.",
"Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as (2S,3R,4R,5S,6R)-2-[3-(4-ethoxybenzyl)-4-chlorophenyl]-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is: Metformin hydrochloride USP. Metformin hydrochloride USP ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, ether, chloroform and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.93 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.93 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg) and 10 mg dapagliflozin and 1,000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablets contain the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate type 1, hypromellose, mannitol, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. In addition, 5 mg/500 mg contains FD&C yellow #6 aluminum lake, 5 mg/1,000 mg and 10 mg/500 mg contains iron oxide red."
},
{
"NDCCode": "59651-191-60",
"PackageDescription": "60000 TABLET, FILM COATED in 1 BAG (59651-191-60) ",
"NDC11Code": "59651-0191-60",
"ProductNDC": "59651-191",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-05-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-SEP-23"
}
]
}
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<NDCList>
<NDC>
<NDCCode>59651-542-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (59651-542-60) </PackageDescription>
<NDC11Code>59651-0542-60</NDC11Code>
<ProductNDC>59651-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216547</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>59651-542-15</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (59651-542-15) / 15 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0542-15</NDC11Code>
<ProductNDC>59651-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216547</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thaizolecarboxamide, monohydrate. The molecular formula is C22H26ClN7O2S. H2O, which corresponds to a formula weight of 506.02 (monohydrate). Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is sparingly soluble in dimethyl sulphoxide, N, N dimethyl formamide and practically insoluble in water.Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>33261-542-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-542-60)</PackageDescription>
<NDC11Code>33261-0542-60</NDC11Code>
<ProductNDC>33261-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>33342-542-09</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-542-09) </PackageDescription>
<NDC11Code>33342-0542-09</NDC11Code>
<ProductNDC>33342-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219530</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with: Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. Tofacitinib tablets are indicated for the treatment of pediatric patients 2 years of age and older with: Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers. Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use: Use of tofacitinib tablets for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.1, 1.2, 1.3, 1.4) Use of tofacitinib tablets for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. (1.5).</IndicationAndUsage>
<Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off white, round shaped, film coated tablets. Each tablet of tofacitinib contains 5 mg of tofacitinib (equivalent to 8.08 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6 mPas, titanium dioxide, macrogol/PEG MW 3350, triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg light blue to blue colored round shaped, film coated tablets. Each 10 mg tablet of tofacitinib contains 10 mg of tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 15 mPas, titanium dioxide, Macrogol/PEG MW 4000, Triacetin, FD&C BLUE #2, FD&C BLUE #1.</Description>
</NDC>
<NDC>
<NDCCode>43063-542-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 PACKAGE (43063-542-60)</PackageDescription>
<NDC11Code>43063-0542-60</NDC11Code>
<ProductNDC>43063-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062058</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43744-542-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-542-60)</PackageDescription>
<NDC11Code>43744-0542-60</NDC11Code>
<ProductNDC>43744-542</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130624</StartMarketingDate>
<EndMarketingDate>20130630</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-542-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45865-542-60)</PackageDescription>
<NDC11Code>45865-0542-60</NDC11Code>
<ProductNDC>45865-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086988</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: povidone, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>49999-542-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49999-542-60)</PackageDescription>
<NDC11Code>49999-0542-60</NDC11Code>
<ProductNDC>49999-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentoxifylline</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075028</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50458-542-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) </PackageDescription>
<NDC11Code>50458-0542-60</NDC11Code>
<ProductNDC>50458-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invokamet</ProprietaryName>
<NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140808</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204353</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.</IndicationAndUsage>
<Description>INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</Description>
</NDC>
<NDC>
<NDCCode>51407-542-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (51407-542-60) </PackageDescription>
<NDC11Code>51407-0542-60</NDC11Code>
<ProductNDC>51407-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208625</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>57483-542-03</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (57483-542-03) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>57483-0542-03</NDC11Code>
<ProductNDC>57483-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Regoxidine</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>Innovus Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-542-60</NDCCode>
<PackageDescription>60 VIAL in 1 PACKAGE (60760-542-60) > 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>60760-0542-60</NDC11Code>
<ProductNDC>60760-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20140130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>St Marys Medical Park Pharmacy</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61649-542-01</NDCCode>
<PackageDescription>60 g in 1 TUBE (61649-542-01) </PackageDescription>
<NDC11Code>61649-0542-01</NDC11Code>
<ProductNDC>61649-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attitude Sunly Kids Mineral Sunscreen Stick Spf 50 Unscented</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>9055-7588 Qu�bec Inc.DBA ATTITUDE</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62900-542-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (62900-542-60) </PackageDescription>
<NDC11Code>62900-0542-60</NDC11Code>
<ProductNDC>62900-542</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Relorn</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>UNIPHARM, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66213-542-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (66213-542-60)</PackageDescription>
<NDC11Code>66213-0542-60</NDC11Code>
<ProductNDC>66213-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Animi-3 With Vitamin D</ProprietaryName>
<NonProprietaryName>Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PBM Pharmaceuticals, Inc</LabelerName>
<SubstanceName>FOLIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; SOY STEROL</SubstanceName>
<StrengthNumber>1; 1000; 12.5; 500; 500; 250; 35; 200</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Animi-3® with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.</IndicationAndUsage>
<Description>Animi-3® with Vitamin D Capsules are intended for oral administration. Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols).Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water).</Description>
</NDC>
<NDC>
<NDCCode>68001-542-60</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (68001-542-60) / 1 mL in 1 VIAL, MULTI-DOSE (68001-542-59) </PackageDescription>
<NDC11Code>68001-0542-60</NDC11Code>
<ProductNDC>68001-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyanocobalamin</ProprietaryName>
<NonProprietaryName>Cyanocobalamin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220624</StartMarketingDate>
<EndMarketingDate>20261031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080737</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [CS], Vitamin B12 [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220624</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-542-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71205-542-60) </PackageDescription>
<NDC11Code>71205-0542-60</NDC11Code>
<ProductNDC>71205-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202659</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated rounde-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-542-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (71610-542-60) </PackageDescription>
<NDC11Code>71610-0542-60</NDC11Code>
<ProductNDC>71610-542</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>59651-009-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60) </PackageDescription>
<NDC11Code>59651-0009-60</NDC11Code>
<ProductNDC>59651-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209081</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59651-010-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-010-60) </PackageDescription>
<NDC11Code>59651-0010-60</NDC11Code>
<ProductNDC>59651-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209081</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an molecular formula of C24H33N3O4, a molecular weight of 427.54 g/mole, and the following structural formula. Ranolazine is a white to off-white powder. Ranolazine is soluble in methanol; practically insoluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type C (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, sodium hydroxide, titanium dioxide and triacetin. In addition, 500 mg tablets contain FD&C yellow # 6/sunset yellow FCF aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59651-042-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-042-60) </PackageDescription>
<NDC11Code>59651-0042-60</NDC11Code>
<ProductNDC>59651-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209694</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59651-043-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-043-60) </PackageDescription>
<NDC11Code>59651-0043-60</NDC11Code>
<ProductNDC>59651-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209694</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59651-084-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-084-60) </PackageDescription>
<NDC11Code>59651-0084-60</NDC11Code>
<ProductNDC>59651-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210385</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsule contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4). It has the following structure. Dimethyl fumarate is a white to off-white powder that is slightly soluble in methanol and highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion (which contains polymer substance based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), methacrylic acid copolymer Type A [which contains poly (methacrylic acid-co-methacrylate) 1:1 and sodium lauryl sulfate], silicified microcrystalline cellulose, talc and triethyl citrate. The empty hard gelatin capsule shell contains gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the 240 mg capsule shell contains FD&C Blue 2 and iron oxide yellow. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>59651-085-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (59651-085-60) </PackageDescription>
<NDC11Code>59651-0085-60</NDC11Code>
<ProductNDC>59651-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darunavir</ProprietaryName>
<NonProprietaryName>Darunavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210677</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DARUNAVIR PROPYLENE GLYCOLATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir tablets contain the active ingredient darunavir, (present as darunavir propylene glycolate) which has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methyl-propyl)amino]-2-hydroxy-1-(phenylmethyl)- propyl]carbamic acid (3R,3aS,6aR)-hexahydro-furo[2,3-b]furan-3-yl ester. 1,2-propanediol solvate. Its molecular formula is C27H37N3O7SC3H8O2 and its molecular weight is 623.73. Darunavir propylene glycolate has the following structural formula. Darunavir propylene glycolate is a white to off-white, slightly hygroscopic powder with a solubility of approximately 0.21 mg per mL in water at 37°C. Darunavir 600 mg tablets are available as orange colored, oval shaped, biconvex, film-coated tablets for oral administration. Each 600 mg tablet contains darunavir 600 mg (present as darunavir propylene glycolate). Darunavir 800 mg tablets are available as dark red colored, oval shaped, biconvex, film-coated tablets for oral administration. Each 800 mg tablet contains darunavir 800 mg (present as darunavir propylene glycolate). Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxyl propyl cellulose, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, talc and titanium dioxide. In addition, the 600 mg tablets contain FD&C Yellow#6/Sunset Yellow FCF aluminum lake. The 800 mg tablets contain iron oxide red. All strengths for darunavir tablets are expressed in terms of the free form of darunavir.</Description>
</NDC>
<NDC>
<NDCCode>59651-118-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-118-60) </PackageDescription>
<NDC11Code>59651-0118-60</NDC11Code>
<ProductNDC>59651-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210740</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>59651-119-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-119-60) </PackageDescription>
<NDC11Code>59651-0119-60</NDC11Code>
<ProductNDC>59651-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210740</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>59651-120-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-120-60) </PackageDescription>
<NDC11Code>59651-0120-60</NDC11Code>
<ProductNDC>59651-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210740</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide capsules can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES). Conversion of Atrial Fibrillation/Flutter Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its molecular formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide USP is a white to off-white powder. It is soluble to sparingly soluble in acetone and 0.1 N hydrochloric acid, sparingly soluble in 0.1 N sodium hydroxide, practically insoluble in isopropyl alcohol and water. Dofetilide capsules contain the following inactive ingredients: corn starch, magnesium stearate and silicified microcrystalline cellulose. The empty hard gelatin capsule shell contains FD&C Yellow No. 6, gelatin and titanium dioxide. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) light orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>59651-144-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (59651-144-60) </PackageDescription>
<NDC11Code>59651-0144-60</NDC11Code>
<ProductNDC>59651-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211058</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59651-155-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-155-60) </PackageDescription>
<NDC11Code>59651-0155-60</NDC11Code>
<ProductNDC>59651-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211489</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as (2S,3R,4R,5S,6R)-2-[3-(4-ethoxybenzyl)-4-chlorophenyl]-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is: Metformin hydrochloride USP. Metformin hydrochloride USP ( N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, ether, chloroform and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.93 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride which is equivalent to 389.93 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg) and 10 mg dapagliflozin and 1,000 mg metformin hydrochloride which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablets contain the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate type 1, hypromellose, mannitol, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. In addition, 5 mg/500 mg contains FD&C yellow #6 aluminum lake, 5 mg/1,000 mg and 10 mg/500 mg contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59651-191-60</NDCCode>
<PackageDescription>60000 TABLET, FILM COATED in 1 BAG (59651-191-60) </PackageDescription>
<NDC11Code>59651-0191-60</NDC11Code>
<ProductNDC>59651-191</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-SEP-23</StartMarketingDatePackage>
</NDC>
</NDCList>