{
"NDC": [
{
"NDCCode": "14445-184-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (14445-184-00) ",
"NDC11Code": "14445-0184-00",
"ProductNDC": "14445-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218445",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
},
{
"NDCCode": "14445-184-10",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (14445-184-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-184-02) ",
"NDC11Code": "14445-0184-10",
"ProductNDC": "14445-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218445",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
},
{
"NDCCode": "14445-184-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30) ",
"NDC11Code": "14445-0184-30",
"ProductNDC": "14445-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218445",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
},
{
"NDCCode": "14445-184-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (14445-184-90) ",
"NDC11Code": "14445-0184-90",
"ProductNDC": "14445-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218445",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red."
},
{
"NDCCode": "12634-184-00",
"PackageDescription": "10 TABLET in 1 BOTTLE (12634-184-00)",
"NDC11Code": "12634-0184-00",
"ProductNDC": "12634-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19720522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080292",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions.",
"Description": "Each tablet for oral administration contains. Prednisone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 mg, 5 mg, 10 mg, 20 mg. Inactive IngredientsPrednisone Tablets, USP of 2.5 mg, 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol."
},
{
"NDCCode": "24196-184-00",
"PackageDescription": "15 kg in 1 DRUM (24196-184-00) ",
"NDC11Code": "24196-0184-00",
"ProductNDC": "24196-184",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Memantine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "MEMANTINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "01-DEC-14"
},
{
"NDCCode": "42973-184-00",
"PackageDescription": "50 kg in 1 DRUM (42973-184-00) ",
"NDC11Code": "42973-0184-00",
"ProductNDC": "42973-184",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Trientine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170712",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "APICORE PHARMACEUTICALS PRIVATE LIMITED",
"SubstanceName": "TRIENTINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-AUG-17"
},
{
"NDCCode": "50988-184-00",
"PackageDescription": "289.82 mL in 1 BOTTLE, PUMP (50988-184-00)",
"NDC11Code": "50988-0184-00",
"ProductNDC": "50988-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming Hand Cleanser",
"NonProprietaryName": "Triclosan",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Jets, Sets, & Elephants Beauty Corp.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".869",
"StrengthUnit": "mL/289.82mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "handwashing to decrease bacteria on skin."
},
{
"NDCCode": "53217-184-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (53217-184-00)",
"NDC11Code": "53217-0184-00",
"ProductNDC": "53217-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19861210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071321",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate."
},
{
"NDCCode": "61722-184-00",
"PackageDescription": "1 TUBE in 1 BOX (61722-184-00) > 30 mL in 1 TUBE",
"NDC11Code": "61722-0184-00",
"ProductNDC": "61722-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flormar Soft Touch Foundation Sunscreen Broad Spectrum Spf 20 St06 Honey",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140706",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Kosan Kozmetik Sanayi ve Ticaret A.S.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140706",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "64220-184-00",
"PackageDescription": "3 kg in 1 CANISTER (64220-184-00) ",
"NDC11Code": "64220-0184-00",
"ProductNDC": "64220-184",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Linagliptin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140923",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Huahai Pharmaceutical Co., Ltd.",
"SubstanceName": "LINAGLIPTIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2022-06-23",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "23-SEP-14"
},
{
"NDCCode": "68001-184-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (68001-184-00) ",
"NDC11Code": "68001-0184-00",
"ProductNDC": "68001-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130228",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) ."
},
{
"NDCCode": "68479-184-00",
"PackageDescription": "3 mL in 1 BOTTLE, DROPPER (68479-184-00) ",
"NDC11Code": "68479-0184-00",
"ProductNDC": "68479-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Age Bright Clearing Serum",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190606",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Dermalogica, Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190606",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "68577-184-00",
"PackageDescription": "30 mg in 1 BOTTLE, GLASS (68577-184-00) ",
"NDC11Code": "68577-0184-00",
"ProductNDC": "68577-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Light Illusion Luminous Makeup Nude-skin Feel Spf18 Sable",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "COSMAX USA, INC",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "4.9; 2; 5",
"StrengthUnit": "mg/100mg; mg/100mg; mg/100mg",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180215",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 helps prevent sunburn, 2 if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "80684-184-00",
"PackageDescription": "34 mL in 1 BOTTLE (80684-184-00) ",
"NDC11Code": "80684-0184-00",
"ProductNDC": "80684-184",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B-pure Moisturizing Hand Sanitizer Sugar Pistachio Scented",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Fourstar Group USA, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251103",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help reduce bacteria on skin."
},
{
"NDCCode": "14445-106-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-106-00) ",
"NDC11Code": "14445-0106-00",
"ProductNDC": "14445-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-107-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-107-00) ",
"NDC11Code": "14445-0107-00",
"ProductNDC": "14445-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-108-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-108-00) ",
"NDC11Code": "14445-0108-00",
"ProductNDC": "14445-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-109-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-109-00) ",
"NDC11Code": "14445-0109-00",
"ProductNDC": "14445-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-110-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-110-00) ",
"NDC11Code": "14445-0110-00",
"ProductNDC": "14445-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-111-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-111-00) ",
"NDC11Code": "14445-0111-00",
"ProductNDC": "14445-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206155",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200814",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg)."
},
{
"NDCCode": "14445-123-00",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (14445-123-00) ",
"NDC11Code": "14445-0123-00",
"ProductNDC": "14445-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208113",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240906",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water."
},
{
"NDCCode": "14445-124-00",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (14445-124-00) ",
"NDC11Code": "14445-0124-00",
"ProductNDC": "14445-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208113",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240906",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water."
},
{
"NDCCode": "14445-125-00",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (14445-125-00) ",
"NDC11Code": "14445-0125-00",
"ProductNDC": "14445-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208113",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240906",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water."
},
{
"NDCCode": "14445-157-00",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (14445-157-00) ",
"NDC11Code": "14445-0157-00",
"ProductNDC": "14445-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Febuxostat",
"NonProprietaryName": "Febuxostat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210292",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "FEBUXOSTAT",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170215",
"SamplePackage": "N",
"IndicationAndUsage": "Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use:. Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.",
"Description": "Febuxostat tablets are xanthine oxidase inhibitor. The active ingredient in febuxostat tablets are 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid hemihydrate, with a molecular weight of 325.38. The empirical formula is C16H16N2O3S. ½ H2O. The chemical structure is. Febuxostat hemihydrate is a non-hygroscopic, white to off white crystalline powder that is freely soluble in dimethylformamide; soluble in tetrahydrofuran; sparingly soluble in acetone and ethanol. The melting range is 203°C to 208°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat hemihydrate, and are available in two dosage strengths; 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, colloidal silicon dioxide and magnesium stearate. Febuxostat tablets are coated with Opadry II, green. The components of Opadry II, green are D&C yellow #10 aluminium lake, FD&C blue #1/ Brilliant blue FCF aluminum lake, FD&C blue #2/ Indigo Carmine AL, Macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide."
},
{
"NDCCode": "14445-170-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-170-00) ",
"NDC11Code": "14445-0170-00",
"ProductNDC": "14445-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
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"RouteName": "ORAL",
"StartMarketingDate": "20160728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204467",
"LabelerName": "Indoco Remedies Limited",
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"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
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"IndicationAndUsage": "Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "14445-171-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-171-00) ",
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"IndicationAndUsage": "Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "14445-172-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-172-00) ",
"NDC11Code": "14445-0172-00",
"ProductNDC": "14445-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "14445-174-00",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (14445-174-00) ",
"NDC11Code": "14445-0174-00",
"ProductNDC": "14445-174",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208113",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240906",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water."
},
{
"NDCCode": "44224-2999-0",
"PackageDescription": "1 KIT in 1 BOX (44224-2999-0) * .7 mL in 1 PACKAGE (44224-0001-2) * 2 TABLET, COATED in 1 PACKET (47682-700-99) * 59 mL in 1 TUBE (44224-5120-0) * 2 TABLET, FILM COATED in 1 PACKET (47682-097-99) * 2 TABLET, FILM COATED in 1 PACKET (47682-125-99) * 30 mL in 1 BOTTLE (44224-3300-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46)",
"NDC11Code": "44224-2999-00",
"ProductNDC": "44224-2999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Easy Care First Aid Kit - Comprehensive",
"NonProprietaryName": "Ammonia, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Acetaminophen, Lidocaine Hydrochloride, Benzalkonium Chloride",
"DosageFormName": "KIT",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tender Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
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<Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
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<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
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<Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) , 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban USP a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each rivaroxaban tablets USP contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of rivaroxaban tablets USP are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban tablets USP 2.5 mg is OpadryÒ Yellow, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, iron oxide yellow and for rivaroxaban 10 mg tablets are OpadryÒ Pink , for rivaroxaban 15 mg tablets are OpadryÒ Red, and rivaroxaban 20 mg tablets are OpadryÒ Red, containing HPMC 2910/hypermellose 15 mpass, titanium dioxide, macrogol 4000/PEG 3350, and iron oxide red.</Description>
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<ProprietaryName>Prednisone</ProprietaryName>
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<LabelerName>Apotheca Inc.</LabelerName>
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<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Prednisone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 mg, 5 mg, 10 mg, 20 mg. Inactive IngredientsPrednisone Tablets, USP of 2.5 mg, 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.</Description>
</NDC>
<NDC>
<NDCCode>24196-184-00</NDCCode>
<PackageDescription>15 kg in 1 DRUM (24196-184-00) </PackageDescription>
<NDC11Code>24196-0184-00</NDC11Code>
<ProductNDC>24196-184</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Memantine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Watson Pharma, Inc.</LabelerName>
<SubstanceName>MEMANTINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-DEC-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>42973-184-00</NDCCode>
<PackageDescription>50 kg in 1 DRUM (42973-184-00) </PackageDescription>
<NDC11Code>42973-0184-00</NDC11Code>
<ProductNDC>42973-184</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Trientine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170712</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>APICORE PHARMACEUTICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>TRIENTINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-AUG-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50988-184-00</NDCCode>
<PackageDescription>289.82 mL in 1 BOTTLE, PUMP (50988-184-00)</PackageDescription>
<NDC11Code>50988-0184-00</NDC11Code>
<ProductNDC>50988-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foaming Hand Cleanser</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Jets, Sets, & Elephants Beauty Corp.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.869</StrengthNumber>
<StrengthUnit>mL/289.82mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53217-184-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53217-184-00)</PackageDescription>
<NDC11Code>53217-0184-00</NDC11Code>
<ProductNDC>53217-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071321</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is. C16H13ClN2O M.W. 284.75. Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>61722-184-00</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (61722-184-00) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>61722-0184-00</NDC11Code>
<ProductNDC>61722-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flormar Soft Touch Foundation Sunscreen Broad Spectrum Spf 20 St06 Honey</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140706</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Kosan Kozmetik Sanayi ve Ticaret A.S.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64220-184-00</NDCCode>
<PackageDescription>3 kg in 1 CANISTER (64220-184-00) </PackageDescription>
<NDC11Code>64220-0184-00</NDC11Code>
<ProductNDC>64220-184</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Linagliptin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140923</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Huahai Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>LINAGLIPTIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-06-23</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68001-184-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68001-184-00) </PackageDescription>
<NDC11Code>68001-0184-00</NDC11Code>
<ProductNDC>68001-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68479-184-00</NDCCode>
<PackageDescription>3 mL in 1 BOTTLE, DROPPER (68479-184-00) </PackageDescription>
<NDC11Code>68479-0184-00</NDC11Code>
<ProductNDC>68479-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Age Bright Clearing Serum</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190606</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Dermalogica, Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68577-184-00</NDCCode>
<PackageDescription>30 mg in 1 BOTTLE, GLASS (68577-184-00) </PackageDescription>
<NDC11Code>68577-0184-00</NDC11Code>
<ProductNDC>68577-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Light Illusion Luminous Makeup Nude-skin Feel Spf18 Sable</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>COSMAX USA, INC</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>4.9; 2; 5</StrengthNumber>
<StrengthUnit>mg/100mg; mg/100mg; mg/100mg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 helps prevent sunburn, 2 if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80684-184-00</NDCCode>
<PackageDescription>34 mL in 1 BOTTLE (80684-184-00) </PackageDescription>
<NDC11Code>80684-0184-00</NDC11Code>
<ProductNDC>80684-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>B-pure Moisturizing Hand Sanitizer Sugar Pistachio Scented</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Fourstar Group USA, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to help reduce bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14445-106-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-106-00) </PackageDescription>
<NDC11Code>14445-0106-00</NDC11Code>
<ProductNDC>14445-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-107-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-107-00) </PackageDescription>
<NDC11Code>14445-0107-00</NDC11Code>
<ProductNDC>14445-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-108-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-108-00) </PackageDescription>
<NDC11Code>14445-0108-00</NDC11Code>
<ProductNDC>14445-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-109-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-109-00) </PackageDescription>
<NDC11Code>14445-0109-00</NDC11Code>
<ProductNDC>14445-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-110-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-110-00) </PackageDescription>
<NDC11Code>14445-0110-00</NDC11Code>
<ProductNDC>14445-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-111-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-111-00) </PackageDescription>
<NDC11Code>14445-0111-00</NDC11Code>
<ProductNDC>14445-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated: As oral formulation for the. As olanzapine and Fluoxetine in Combination for the: : 1 Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (Olanzapine and fluoxetine in combination); refer to the product label for Symbyax, 2 Treatment of treatment resistant depression. (1.6) , 3 Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The color coating contains Hypromellose (all strengths), Triacetin (all strengths), Talc (all strengths),Titanium Dioxide (all strengths), Polyethylene glycol (2.5mg, 5mg, 7.5mg 10mg and 20mg), Polysorbate 80 (2.5mg, 5mg, 7.5mg and 10mg), Lactose monohydrate, (15mg and 20mg ) FD&C Blue No. 2 Aluminum Lake (15 mg), and Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>14445-123-00</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (14445-123-00) </PackageDescription>
<NDC11Code>14445-0123-00</NDC11Code>
<ProductNDC>14445-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208113</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water.</Description>
</NDC>
<NDC>
<NDCCode>14445-124-00</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (14445-124-00) </PackageDescription>
<NDC11Code>14445-0124-00</NDC11Code>
<ProductNDC>14445-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208113</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water.</Description>
</NDC>
<NDC>
<NDCCode>14445-125-00</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (14445-125-00) </PackageDescription>
<NDC11Code>14445-0125-00</NDC11Code>
<ProductNDC>14445-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208113</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water.</Description>
</NDC>
<NDC>
<NDCCode>14445-157-00</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (14445-157-00) </PackageDescription>
<NDC11Code>14445-0157-00</NDC11Code>
<ProductNDC>14445-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Febuxostat</ProprietaryName>
<NonProprietaryName>Febuxostat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210292</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>FEBUXOSTAT</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. For the safe and effective use of allopurinol, see allopurinol prescribing information. Limitations of Use:. Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.</IndicationAndUsage>
<Description>Febuxostat tablets are xanthine oxidase inhibitor. The active ingredient in febuxostat tablets are 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-1,3-thiazole-5-carboxylic acid hemihydrate, with a molecular weight of 325.38. The empirical formula is C16H16N2O3S. ½ H2O. The chemical structure is. Febuxostat hemihydrate is a non-hygroscopic, white to off white crystalline powder that is freely soluble in dimethylformamide; soluble in tetrahydrofuran; sparingly soluble in acetone and ethanol. The melting range is 203°C to 208°C. Febuxostat tablets for oral use contain the active ingredient, febuxostat hemihydrate, and are available in two dosage strengths; 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, colloidal silicon dioxide and magnesium stearate. Febuxostat tablets are coated with Opadry II, green. The components of Opadry II, green are D&C yellow #10 aluminium lake, FD&C blue #1/ Brilliant blue FCF aluminum lake, FD&C blue #2/ Indigo Carmine AL, Macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>14445-170-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-170-00) </PackageDescription>
<NDC11Code>14445-0170-00</NDC11Code>
<ProductNDC>14445-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204467</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>14445-171-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-171-00) </PackageDescription>
<NDC11Code>14445-0171-00</NDC11Code>
<ProductNDC>14445-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204467</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>14445-172-00</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (14445-172-00) </PackageDescription>
<NDC11Code>14445-0172-00</NDC11Code>
<ProductNDC>14445-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204467</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula:. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone.Each scored white round tablet contains 200 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate and povidone. Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>14445-174-00</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (14445-174-00) </PackageDescription>
<NDC11Code>14445-0174-00</NDC11Code>
<ProductNDC>14445-174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208113</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. 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 - 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide, sodium lauryl sulfate and colloidal silicon dioxide, water and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide, water. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, strong ammonia solution and purified water.</Description>
</NDC>
<NDC>
<NDCCode>44224-2999-0</NDCCode>
<PackageDescription>1 KIT in 1 BOX (44224-2999-0) * .7 mL in 1 PACKAGE (44224-0001-2) * 2 TABLET, COATED in 1 PACKET (47682-700-99) * 59 mL in 1 TUBE (44224-5120-0) * 2 TABLET, FILM COATED in 1 PACKET (47682-097-99) * 2 TABLET, FILM COATED in 1 PACKET (47682-125-99) * 30 mL in 1 BOTTLE (44224-3300-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46)</PackageDescription>
<NDC11Code>44224-2999-00</NDC11Code>
<ProductNDC>44224-2999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Easy Care First Aid Kit - Comprehensive</ProprietaryName>
<NonProprietaryName>Ammonia, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Acetaminophen, Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tender Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>