{
"NDC": [
{
"NDCCode": "59746-224-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (59746-224-05) ",
"NDC11Code": "59746-0224-05",
"ProductNDC": "59746-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59746-224-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (59746-224-60) ",
"NDC11Code": "59746-0224-60",
"ProductNDC": "59746-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "14534-224-05",
"PackageDescription": "25 kg in 1 DRUM (14534-224-05)",
"NDC11Code": "14534-0224-05",
"ProductNDC": "14534-224",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191029",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "JQC (Huayin) Pharmaceutical Co., Ltd.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2019-11-02",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "16590-224-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (16590-224-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "16590-0224-05",
"ProductNDC": "16590-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19960131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064096",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tobramycin Ophthalmic Solution USP, 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in pediatric patients.",
"Description": "Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:. Chemical Name. O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 → 4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)}-2- deoxystreptamine. Each mL contains. Active: Tobramycin 3 mg (0.3%). Inactives: Boric Acid, Sodium Chloride, Sodium Sulfate, Tyloxapol, Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%)."
},
{
"NDCCode": "16729-224-05",
"PackageDescription": "1 VIAL in 1 CARTON (16729-224-05) / 20 mL in 1 VIAL",
"NDC11Code": "16729-0224-05",
"ProductNDC": "16729-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decitabine",
"NonProprietaryName": "Decitabine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203475",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "DECITABINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170308",
"SamplePackage": "N",
"IndicationAndUsage": "Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novoand secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.",
"Description": "Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C 8H 12N 4O 4and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1 H)-one and it has the following structural formula:. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide."
},
{
"NDCCode": "37205-224-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (37205-224-05) > 15 mL in 1 BOTTLE",
"NDC11Code": "37205-0224-05",
"ProductNDC": "37205-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Advanced Formula",
"NonProprietaryName": "Dextran70, Polyethylene Glycol, Povidone, Tetrahydrozoline Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20120104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "CARDINAL HEALTH",
"SubstanceName": "DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": "1; 10; 10; .5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Directions: 1 put 1 to 2 drops in the affected eye(s) up to 4 times daily, 2 children under 6 years of age: ask a doctor."
},
{
"NDCCode": "43598-224-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-224-05)",
"NDC11Code": "43598-0224-05",
"ProductNDC": "43598-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19780710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050754",
"LabelerName": "Dr Reddys Laboratories Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50066-224-05",
"PackageDescription": "5 POUCH in 1 CARTON (50066-224-05) > 1 PATCH in 1 POUCH",
"NDC11Code": "50066-0224-05",
"ProductNDC": "50066-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dragon Pain Relief",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190118",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Genomma Lab USA, Inc.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190118",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. adults and children over 12 years: 1 clean and dry affected area, 2 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle, 3 carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area, 4 once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area , 5 use 1 patch for up to 12 hours."
},
{
"NDCCode": "57237-224-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (57237-224-05) ",
"NDC11Code": "57237-0224-05",
"ProductNDC": "57237-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091604",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110608",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white to almost white crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105° to 112°C.The CAS Registry Number is 87333-19-5. Ramipril’s chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch and silica hydrophobic, colloidal anhydrous. The empty hard gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 1.25 mg capsule shell contains iron oxide yellow, 2.5 mg capsule shell contains D&C yellow 10 and FD&C red 40, the 5 mg capsule shell contains FD&C blue 1 and FD&C red 40, and the 10 mg capsule shell contains FD&C blue 1. The capsules are printed with edible ink containing black iron oxide and shellac. The structural formula for ramipril is. Its molecular formula is C23H32N2O5 and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "57896-224-05",
"PackageDescription": "50 TABLET in 1 BOTTLE (57896-224-05) ",
"NDC11Code": "57896-0224-05",
"ProductNDC": "57896-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Night Time Pain Medicine",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Geri-Care Pharmaceutical Corp",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240701",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness."
},
{
"NDCCode": "61314-224-05",
"PackageDescription": "5 mL in 1 BOTTLE (61314-224-05) ",
"NDC11Code": "61314-0224-05",
"ProductNDC": "61314-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Gfs",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION, GEL FORMING / DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19981224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020963",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981224",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°. 405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "61919-224-05",
"PackageDescription": "1 mL in 1 CARTON (61919-224-05)",
"NDC11Code": "61919-0224-05",
"ProductNDC": "61919-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064052",
"LabelerName": "Direct Rx",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tobramycin Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children. Close.",
"Description": "Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections. EACH mL CONTAINS. ACTIVE: Tobramycin 3 mg (0.3%). INACTIVES: Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol and Purified Water. Sodium Hydroxide and/or Sulfuric Acid may be added to adjust pH (7.0 - 8.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.1 mg (0.01%). The structural formula of tobramycin is. Molecular formula: C18H37N5O9. Molecular weight: 467.52. Chemical name. O-[3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 → 4)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl- (1 → 6)]-2-deoxystreptamine. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. Close."
},
{
"NDCCode": "62935-223-05",
"PackageDescription": "1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05) ",
"NDC11Code": "62935-0223-05",
"ProductNDC": "62935-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eligard",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20020826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021379",
"LabelerName": "TOLMAR Inc.",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020826",
"SamplePackage": "N",
"IndicationAndUsage": "ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.",
"Description": "ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot. One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD® product. Table 6. ELIGARD® Delivery System Composition and Reconstituted Product Formulation."
},
{
"NDCCode": "63304-224-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-224-05)",
"NDC11Code": "63304-0224-05",
"ProductNDC": "63304-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxymorphone Hydrochloride",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203506",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&C yellow No. 6. The 20 mg tablets contain D&C yellow No. 10, FD&C blue No. 1, and FD&C yellow No. 6. The 30 mg tablets contain FD&C blue No. 1 and FD&C yellow No. 6. The 40 mg tablets contain D&C yellow No. 10 and FD&C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows."
},
{
"NDCCode": "63922-224-05",
"PackageDescription": "5 PATCH in 1 BOX (63922-224-05)",
"NDC11Code": "63922-0224-05",
"ProductNDC": "63922-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kgs Bao Zhen Gao",
"ProprietaryNameSuffix": "Medicated Plaster Extra Strength",
"NonProprietaryName": "Methyl Salicylate Menthol Camphor",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Kingsway Trading Inc.",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC)",
"StrengthNumber": "14; 7; 7",
"StrengthUnit": "g/1; g/1; g/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the temporarily relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains. ■ bruises ■ sprains."
},
{
"NDCCode": "64220-224-05",
"PackageDescription": "10 kg in 1 DRUM (64220-224-05) ",
"NDC11Code": "64220-0224-05",
"ProductNDC": "64220-224",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240923",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-09-25",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-SEP-24"
},
{
"NDCCode": "67877-224-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (67877-224-05) ",
"NDC11Code": "67877-0224-05",
"ProductNDC": "67877-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090858",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110129",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, and titanium dioxide."
},
{
"NDCCode": "68382-224-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05) ",
"NDC11Code": "68382-0224-05",
"ProductNDC": "68382-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bicalutamide",
"NonProprietaryName": "Bicalutamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079089",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "BICALUTAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20090706",
"SamplePackage": "N"
},
{
"NDCCode": "68428-224-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-224-05) ",
"NDC11Code": "68428-0224-05",
"ProductNDC": "68428-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana, Radix",
"NonProprietaryName": "Arnica Montana Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101011",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20101011",
"SamplePackage": "N"
},
{
"NDCCode": "68786-224-05",
"PackageDescription": "1728 PACKET in 1 CASE (68786-224-05) > .5 g in 1 PACKET",
"NDC11Code": "68786-0224-05",
"ProductNDC": "68786-224",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120706",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Sion Biotext Medical Ltd",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120706",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "72888-224-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-224-05) ",
"NDC11Code": "72888-0224-05",
"ProductNDC": "72888-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219689",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"IndicationAndUsage": "Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] .",
"Description": "Guanfacine extended-release tablets, USP is a once-daily, extended-release formulation of guanfacine hydrochloride, USP in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9H 9C l2N 3O·HCl corresponding to a molecular weight of 282.55. The chemical structure is:. Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains Guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid copolymer, lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, fumaric acid, and glyceryl dibehenate. In addition, the 3-mg and 4-mg tablets also contain ferric oxide and FD&C Blue 2 Al lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "87063-224-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (87063-224-05) ",
"NDC11Code": "87063-0224-05",
"ProductNDC": "87063-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole Tablets",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206037",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260615",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole ( 1.3) .",
"Description": "Anastrozole Tablets，USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole, USP is an off-white powder with a molecular weight of 293.4. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole, USP is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol sodium starch glycolate, and titanium dioxide ."
},
{
"NDCCode": "59746-216-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-216-05) ",
"NDC11Code": "59746-0216-05",
"ProductNDC": "59746-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203253",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "59746-217-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-217-05) ",
"NDC11Code": "59746-0217-05",
"ProductNDC": "59746-217",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203253",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "59746-218-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59746-218-05) ",
"NDC11Code": "59746-0218-05",
"ProductNDC": "59746-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spironolactone",
"NonProprietaryName": "Spironolactone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203253",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "SPIRONOLACTONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .",
"Description": "Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "59746-221-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (59746-221-05) ",
"NDC11Code": "59746-0221-05",
"ProductNDC": "59746-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59746-222-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (59746-222-05) ",
"NDC11Code": "59746-0222-05",
"ProductNDC": "59746-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078828",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251015",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
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"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
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"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
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"Description": "Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake."
}
]
}
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<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
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<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<Description>Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Tobramycin is a water soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The molecular formula is C18H37N5O9, the molecular weight is 467.52 and the structural formula is:. Chemical Name. O-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1 → 4)}-O-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1 → 6)}-2- deoxystreptamine. Each mL contains. Active: Tobramycin 3 mg (0.3%). Inactives: Boric Acid, Sodium Chloride, Sodium Sulfate, Tyloxapol, Sodium Hydroxide and/or Sulfuric Acid to adjust pH (7.0 to 8.0), and Purified Water USP. Preservative: Benzalkonium Chloride 0.1 mg (0.01%).</Description>
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<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<LabelerName>Genomma Lab USA, Inc.</LabelerName>
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<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. adults and children over 12 years: 1 clean and dry affected area, 2 remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle, 3 carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area, 4 once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area , 5 use 1 patch for up to 12 hours.</IndicationAndUsage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white to almost white crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105° to 112°C.The CAS Registry Number is 87333-19-5. Ramipril’s chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester. The inactive ingredients present are pregelatinized starch and silica hydrophobic, colloidal anhydrous. The empty hard gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 1.25 mg capsule shell contains iron oxide yellow, 2.5 mg capsule shell contains D&C yellow 10 and FD&C red 40, the 5 mg capsule shell contains FD&C blue 1 and FD&C red 40, and the 10 mg capsule shell contains FD&C blue 1. The capsules are printed with edible ink containing black iron oxide and shellac. The structural formula for ramipril is. Its molecular formula is C23H32N2O5 and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>57896-224-05</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (57896-224-05) </PackageDescription>
<NDC11Code>57896-0224-05</NDC11Code>
<ProductNDC>57896-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Night Time Pain Medicine</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Geri-Care Pharmaceutical Corp</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of occasional headaches and minor aches and pains along with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61314-224-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (61314-224-05) </PackageDescription>
<NDC11Code>61314-0224-05</NDC11Code>
<ProductNDC>61314-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Gfs</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19981224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020963</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol GFS (timolol maleate ophthalmic gel forming solution) is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thia diazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. [α] 25° in 0.1N HCl (C=5%) = -12.2°. 405 nm. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol GFS is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths. Timolol GFS has a pH of approximately 6.9 and an osmolality of approximately 290 mOsmol/kg. Each mL of Timolol GFS 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol GFS 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: boric acid, mannitol, polysorbate-80, tromethamine, xanthan gum, and purified water. Preservative: benzododecinium bromide 0.012%. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, Timolol GFS forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>61919-224-05</NDCCode>
<PackageDescription>1 mL in 1 CARTON (61919-224-05)</PackageDescription>
<NDC11Code>61919-0224-05</NDC11Code>
<ProductNDC>61919-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064052</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tobramycin Ophthalmic Solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children. Close.</IndicationAndUsage>
<Description>Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external infections. EACH mL CONTAINS. ACTIVE: Tobramycin 3 mg (0.3%). INACTIVES: Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol and Purified Water. Sodium Hydroxide and/or Sulfuric Acid may be added to adjust pH (7.0 - 8.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.1 mg (0.01%). The structural formula of tobramycin is. Molecular formula: C18H37N5O9. Molecular weight: 467.52. Chemical name. O-[3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 → 4)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl- (1 → 6)]-2-deoxystreptamine. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. Close.</Description>
</NDC>
<NDC>
<NDCCode>62935-223-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62935-223-05) * .375 mL in 1 SYRINGE (62935-221-04) * .375 mL in 1 SYRINGE (62935-224-05) </PackageDescription>
<NDC11Code>62935-0223-05</NDC11Code>
<ProductNDC>62935-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eligard</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20020826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021379</ApplicationNumber>
<LabelerName>TOLMAR Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.</IndicationAndUsage>
<Description>ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot. One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate. ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP). Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD® product. Table 6. ELIGARD® Delivery System Composition and Reconstituted Product Formulation.</Description>
</NDC>
<NDC>
<NDCCode>63304-224-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-224-05)</PackageDescription>
<NDC11Code>63304-0224-05</NDC11Code>
<ProductNDC>63304-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxymorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203506</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Oxymorphone hydrochloride extended-release tablets are for oral use and contain oxymorphone, a semi-synthetic opioid analgesic. Oxymorphone hydrochloride extended-release tablets are supplied in 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg tablet strengths for oral administration. The tablet strength describes the amount of oxymorphone hydrochloride, USP per tablet. The tablets contain the following inactive ingredients: hydrophobic colloidal silica, hypromellose, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 5 mg and 30 mg tablets contain FD&C red No. 40. The 7.5 mg tablets contain ferric oxide black, and ferric oxide yellow. The 10 mg tablets contain ferric oxide yellow and FD&C yellow No. 6. The 20 mg tablets contain D&C yellow No. 10, FD&C blue No. 1, and FD&C yellow No. 6. The 30 mg tablets contain FD&C blue No. 1 and FD&C yellow No. 6. The 40 mg tablets contain D&C yellow No. 10 and FD&C yellow No. 6. The chemical name of oxymorphone hydrochloride is 4, 5α -epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride, a white to off-white powder, which is sparingly soluble in alcohol, but freely soluble in water. The molecular weight of oxymorphone hydrochloride is 337.80. The molecular formula of oxymorphone hydrochloride is C17H19NO4.HCl. The pKa1 and pKa2 of oxymorphone at 37° C are 8.17 and 9.54, respectively. The octanol/aqueous partition coefficient at 37° C and pH 7.4 is 0.98. The structural formula for oxymorphone hydrochloride is as follows.</Description>
</NDC>
<NDC>
<NDCCode>63922-224-05</NDCCode>
<PackageDescription>5 PATCH in 1 BOX (63922-224-05)</PackageDescription>
<NDC11Code>63922-0224-05</NDC11Code>
<ProductNDC>63922-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kgs Bao Zhen Gao</ProprietaryName>
<ProprietaryNameSuffix>Medicated Plaster Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Methyl Salicylate Menthol Camphor</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Kingsway Trading Inc.</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
<StrengthNumber>14; 7; 7</StrengthNumber>
<StrengthUnit>g/1; g/1; g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporarily relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains. ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-224-05</NDCCode>
<PackageDescription>10 kg in 1 DRUM (64220-224-05) </PackageDescription>
<NDC11Code>64220-0224-05</NDC11Code>
<ProductNDC>64220-224</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240923</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-09-25</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-SEP-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67877-224-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (67877-224-05) </PackageDescription>
<NDC11Code>67877-0224-05</NDC11Code>
<ProductNDC>67877-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090858</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-224-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05) </PackageDescription>
<NDC11Code>68382-0224-05</NDC11Code>
<ProductNDC>68382-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bicalutamide</ProprietaryName>
<NonProprietaryName>Bicalutamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079089</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BICALUTAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-224-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-224-05) </PackageDescription>
<NDC11Code>68428-0224-05</NDC11Code>
<ProductNDC>68428-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana, Radix</ProprietaryName>
<NonProprietaryName>Arnica Montana Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68786-224-05</NDCCode>
<PackageDescription>1728 PACKET in 1 CASE (68786-224-05) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>68786-0224-05</NDC11Code>
<ProductNDC>68786-224</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120706</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Sion Biotext Medical Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120706</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72888-224-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72888-224-05) </PackageDescription>
<NDC11Code>72888-0224-05</NDC11Code>
<ProductNDC>72888-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219689</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Guanfacine extended-release tablets, USP is a once-daily, extended-release formulation of guanfacine hydrochloride, USP in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9H 9C l2N 3O·HCl corresponding to a molecular weight of 282.55. The chemical structure is:. Guanfacine hydrochloride, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains Guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain hypromellose, methacrylic acid copolymer, lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, fumaric acid, and glyceryl dibehenate. In addition, the 3-mg and 4-mg tablets also contain ferric oxide and FD&C Blue 2 Al lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>87063-224-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (87063-224-05) </PackageDescription>
<NDC11Code>87063-0224-05</NDC11Code>
<ProductNDC>87063-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole Tablets</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206037</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to Anastrozole ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets，USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole, USP is an off-white powder with a molecular weight of 293.4. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole, USP is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol sodium starch glycolate, and titanium dioxide .</Description>
</NDC>
<NDC>
<NDCCode>59746-216-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-216-05) </PackageDescription>
<NDC11Code>59746-0216-05</NDC11Code>
<ProductNDC>59746-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203253</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-217-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-217-05) </PackageDescription>
<NDC11Code>59746-0217-05</NDC11Code>
<ProductNDC>59746-217</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203253</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-218-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59746-218-05) </PackageDescription>
<NDC11Code>59746-0218-05</NDC11Code>
<ProductNDC>59746-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spironolactone</ProprietaryName>
<NonProprietaryName>Spironolactone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203253</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>SPIRONOLACTONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Spironolactone tablets are aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1), 2 Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2), 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosternism for: (1.4)Short-term preoperative treatmentLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia .</IndicationAndUsage>
<Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone, USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, ferric oxide black, ferric oxide red, ferric oxide yellow, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-221-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-221-05) </PackageDescription>
<NDC11Code>59746-0221-05</NDC11Code>
<ProductNDC>59746-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59746-222-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-222-05) </PackageDescription>
<NDC11Code>59746-0222-05</NDC11Code>
<ProductNDC>59746-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59746-223-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-223-05) </PackageDescription>
<NDC11Code>59746-0223-05</NDC11Code>
<ProductNDC>59746-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59746-225-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-225-05) </PackageDescription>
<NDC11Code>59746-0225-05</NDC11Code>
<ProductNDC>59746-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59746-226-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (59746-226-05) </PackageDescription>
<NDC11Code>59746-0226-05</NDC11Code>
<ProductNDC>59746-226</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078828</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone is atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone Tablets contain risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is. Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets are available in 0.25 mg (dark yellow), 0.5 mg (reddish brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, propylene glycol, starch (corn), talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
</NDCList>