{
"NDC": [
{
"NDCCode": "14445-107-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-107-30) ",
"NDC11Code": "14445-0107-30",
"ProductNDC": "14445-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
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"RouteName": "ORAL",
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"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": "14445-107-00",
"PackageDescription": "1000 TABLET in 1 BOTTLE (14445-107-00) ",
"NDC11Code": "14445-0107-00",
"ProductNDC": "14445-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"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": "14445-107-10",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (14445-107-10) ",
"NDC11Code": "14445-0107-10",
"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": "14445-022-09",
"PackageDescription": "30 kg in 1 DRUM (14445-022-09) ",
"NDC11Code": "14445-0022-09",
"ProductNDC": "14445-022",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210708",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-13",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "08-JUL-21"
},
{
"NDCCode": "14445-023-09",
"PackageDescription": "30 kg in 1 DRUM (14445-023-09) ",
"NDC11Code": "14445-0023-09",
"ProductNDC": "14445-023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lacosamide",
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"StartMarketingDate": "20240306",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
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"StrengthUnit": "kg/kg",
"DEASchedule": "CV",
"Status": "Unfinished",
"LastUpdate": "2025-11-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "06-MAR-24"
},
{
"NDCCode": "14445-024-09",
"PackageDescription": "30 kg in 1 DRUM (14445-024-09) ",
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"ProductNDC": "14445-024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240315",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-05-22",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "15-MAR-24"
},
{
"NDCCode": "14445-104-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-104-30) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasagiline Mesylate",
"NonProprietaryName": "Rasagiline Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206153",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N"
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{
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"PackageDescription": "30 TABLET in 1 BOTTLE (14445-105-30) ",
"NDC11Code": "14445-0105-30",
"ProductNDC": "14445-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Rasagiline Mesylate",
"DosageFormName": "TABLET",
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"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206153",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "RASAGILINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150101",
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},
{
"NDCCode": "14445-106-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-106-30) ",
"NDC11Code": "14445-0106-30",
"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": "14445-108-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-108-30) ",
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"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": "14445-109-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-109-30) ",
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"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": "14445-110-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-110-30) ",
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"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": "14445-111-30",
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"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)."
},
{
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"ProductNDC": "14445-148",
"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": "10",
"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": "14445-152-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "14445-0152-30",
"ProductNDC": "14445-152",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218895",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241004",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat."
},
{
"NDCCode": "14445-156-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (14445-156-30) ",
"NDC11Code": "14445-0156-30",
"ProductNDC": "14445-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Febuxostat",
"NonProprietaryName": "Febuxostat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210292",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "FEBUXOSTAT",
"StrengthNumber": "40",
"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": "20170214",
"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": "14445-157-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (14445-157-30) ",
"NDC11Code": "14445-0157-30",
"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": "14445-170-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (14445-170-30) ",
"NDC11Code": "14445-0170-30",
"ProductNDC": "14445-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204467",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160728",
"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": "14445-183-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (14445-183-30) ",
"NDC11Code": "14445-0183-30",
"ProductNDC": "14445-183",
"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": "15",
"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": "14445-412-04",
"PackageDescription": "4 VIAL in 1 CARTON (14445-412-04) > 30 mL in 1 VIAL (14445-412-30) ",
"NDC11Code": "14445-0412-04",
"ProductNDC": "14445-412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215620",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"Status": "Active",
"LastUpdate": "2022-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).",
"Description": "Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine injection contains the following inactive ingredients: edetate disodium dihydrate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP."
},
{
"NDCCode": "10237-107-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-107-01) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "10237-0107-01",
"ProductNDC": "10237-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland Power Mist Hand Sanitizer Pure Lavender",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to decrease bacteria on the skin recommended for repeated use."
},
{
"NDCCode": "10237-136-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-136-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-111-00) ",
"NDC11Code": "10237-0136-00",
"ProductNDC": "10237-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland The Daydream Set Power Mist Power Mist Hydrating Hand Sanitizer Mist",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "10237-137-00",
"PackageDescription": "1 KIT in 1 CARTON (10237-137-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-130-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-114-00) ",
"NDC11Code": "10237-0137-00",
"ProductNDC": "10237-137",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touchland The Main Character Set",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "10544-107-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-107-30)",
"NDC11Code": "10544-0107-30",
"ProductNDC": "10544-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "10812-107-01",
"PackageDescription": "30 CLOTH in 1 CELLO PACK (10812-107-01)",
"NDC11Code": "10812-0107-01",
"ProductNDC": "10812-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Oil Free Acne Wash",
"ProprietaryNameSuffix": "Cleansing",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120329",
"EndMarketingDate": "20151101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "11673-107-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (11673-107-30) > 30 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "11673-0107-30",
"ProductNDC": "11673-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131130",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "TARGET Corporation",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "13668-107-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30) ",
"NDC11Code": "13668-0107-30",
"ProductNDC": "13668-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rabeprazole Sodium",
"NonProprietaryName": "Rabeprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202376",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131108",
"SamplePackage": "N",
"IndicationAndUsage": "Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: 1 Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). , 2 Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). , 3 Treatment of Symptomatic GERD ( 1.3). , 4 Healing of Duodenal Ulcers ( 1.4). , 5 Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5). , 6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). .",
"Description": "The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium hydrate, USP, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium hydrate, USP is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium hydrate, USP is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is. Rabeprazole sodium hydrate, USP is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium hydrate, USP. Inactive ingredients of the 20 mg tablet are diethyl phthalate, ethylcellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, povidone, sodium starch glycolate, talc, and titanium dioxide. Ferric oxide yellow is the coloring agent for the tablet coating."
},
{
"NDCCode": "16714-107-01",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-107-01) ",
"NDC11Code": "16714-0107-01",
"ProductNDC": "16714-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202261",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "105",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160613",
"SamplePackage": "N"
},
{
"NDCCode": "17271-107-03",
"PackageDescription": "10 CARTON in 1 BOX (17271-107-03) / 30 PACKAGE in 1 CARTON / 18 mL in 1 PACKAGE",
"NDC11Code": "17271-0107-03",
"ProductNDC": "17271-107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bd E-z Scrub 107",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19891024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072525",
"LabelerName": "Becton Dickinson and Company",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "40",
"StrengthUnit": "g/1000mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19891024",
"SamplePackage": "N",
"IndicationAndUsage": "preoperative cleaning of healthcare personnel arms and hands."
}
]
}
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<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>
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<PackageDescription>1000 TABLET in 1 BOTTLE (14445-107-00) </PackageDescription>
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<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>
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<PackageDescription>100 TABLET in 1 BLISTER PACK (14445-107-10) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206155</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
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<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>
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<PackageDescription>30 kg in 1 DRUM (14445-022-09) </PackageDescription>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
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<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-13</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-JUL-21</StartMarketingDatePackage>
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<PackageDescription>30 kg in 1 DRUM (14445-023-09) </PackageDescription>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2025-11-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-MAR-24</StartMarketingDatePackage>
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<NDC>
<NDCCode>14445-024-09</NDCCode>
<PackageDescription>30 kg in 1 DRUM (14445-024-09) </PackageDescription>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
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<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-05-22</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-MAR-24</StartMarketingDatePackage>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206153</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
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<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>30 TABLET in 1 BOTTLE (14445-105-30) </PackageDescription>
<NDC11Code>14445-0105-30</NDC11Code>
<ProductNDC>14445-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasagiline Mesylate</ProprietaryName>
<NonProprietaryName>Rasagiline Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206153</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>RASAGILINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-106-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-106-30) </PackageDescription>
<NDC11Code>14445-0106-30</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>14445-108-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-108-30) </PackageDescription>
<NDC11Code>14445-0108-30</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>14445-109-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-109-30) </PackageDescription>
<NDC11Code>14445-0109-30</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>14445-110-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-110-30) </PackageDescription>
<NDC11Code>14445-0110-30</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>14445-111-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-111-30) </PackageDescription>
<NDC11Code>14445-0111-30</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>14445-148-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-148-30) </PackageDescription>
<NDC11Code>14445-0148-30</NDC11Code>
<ProductNDC>14445-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218445</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>14445-152-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (14445-152-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>14445-0152-30</NDC11Code>
<ProductNDC>14445-152</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218895</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14445-156-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-156-30) </PackageDescription>
<NDC11Code>14445-0156-30</NDC11Code>
<ProductNDC>14445-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Febuxostat</ProprietaryName>
<NonProprietaryName>Febuxostat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210292</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>FEBUXOSTAT</SubstanceName>
<StrengthNumber>40</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>20170214</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>14445-157-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-157-30) </PackageDescription>
<NDC11Code>14445-0157-30</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>14445-170-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (14445-170-30) </PackageDescription>
<NDC11Code>14445-0170-30</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>14445-183-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-183-30) </PackageDescription>
<NDC11Code>14445-0183-30</NDC11Code>
<ProductNDC>14445-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218445</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>14445-184-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (14445-184-30) </PackageDescription>
<NDC11Code>14445-0184-30</NDC11Code>
<ProductNDC>14445-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218445</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>14445-412-04</NDCCode>
<PackageDescription>4 VIAL in 1 CARTON (14445-412-04) > 30 mL in 1 VIAL (14445-412-30) </PackageDescription>
<NDC11Code>14445-0412-04</NDC11Code>
<ProductNDC>14445-412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215620</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).</IndicationAndUsage>
<Description>Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula. Acetylcysteine injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine injection contains the following inactive ingredients: edetate disodium dihydrate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>10237-107-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-107-01) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>10237-0107-01</NDC11Code>
<ProductNDC>10237-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland Power Mist Hand Sanitizer Pure Lavender</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-136-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-136-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-102-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-111-00) </PackageDescription>
<NDC11Code>10237-0136-00</NDC11Code>
<ProductNDC>10237-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland The Daydream Set Power Mist Power Mist Hydrating Hand Sanitizer Mist</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-137-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10237-137-00) * 30 mL in 1 BOTTLE, SPRAY (10237-107-00) * 30 mL in 1 BOTTLE, SPRAY (10237-130-00) * 30 mL in 1 BOTTLE, SPRAY (10237-100-00) * 30 mL in 1 BOTTLE, SPRAY (10237-114-00) </PackageDescription>
<NDC11Code>10237-0137-00</NDC11Code>
<ProductNDC>10237-137</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland The Main Character Set</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10544-107-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-107-30)</PackageDescription>
<NDC11Code>10544-0107-30</NDC11Code>
<ProductNDC>10544-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored, and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>10812-107-01</NDCCode>
<PackageDescription>30 CLOTH in 1 CELLO PACK (10812-107-01)</PackageDescription>
<NDC11Code>10812-0107-01</NDC11Code>
<ProductNDC>10812-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Oil Free Acne Wash</ProprietaryName>
<ProprietaryNameSuffix>Cleansing</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120329</StartMarketingDate>
<EndMarketingDate>20151101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-107-30</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (11673-107-30) > 30 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>11673-0107-30</NDC11Code>
<ProductNDC>11673-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131130</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131130</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13668-107-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30) </PackageDescription>
<NDC11Code>13668-0107-30</NDC11Code>
<ProductNDC>13668-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rabeprazole Sodium</ProprietaryName>
<NonProprietaryName>Rabeprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202376</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: 1 Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1). , 2 Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2). , 3 Treatment of Symptomatic GERD ( 1.3). , 4 Healing of Duodenal Ulcers ( 1.4). , 5 Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5). , 6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6). .</IndicationAndUsage>
<Description>The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium hydrate, USP, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium hydrate, USP is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium hydrate, USP is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is. Rabeprazole sodium hydrate, USP is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium hydrate, USP. Inactive ingredients of the 20 mg tablet are diethyl phthalate, ethylcellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, povidone, sodium starch glycolate, talc, and titanium dioxide. Ferric oxide yellow is the coloring agent for the tablet coating.</Description>
</NDC>
<NDC>
<NDCCode>16714-107-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-107-01) </PackageDescription>
<NDC11Code>16714-0107-01</NDC11Code>
<ProductNDC>16714-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202261</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17271-107-03</NDCCode>
<PackageDescription>10 CARTON in 1 BOX (17271-107-03) / 30 PACKAGE in 1 CARTON / 18 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>17271-0107-03</NDC11Code>
<ProductNDC>17271-107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bd E-z Scrub 107</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19891024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072525</ApplicationNumber>
<LabelerName>Becton Dickinson and Company</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19891024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>preoperative cleaning of healthcare personnel arms and hands.</IndicationAndUsage>
</NDC>
</NDCList>