{
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{
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"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-234-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-234-10) ",
"NDC11Code": "72143-0234-30",
"ProductNDC": "72143-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
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"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5."
},
{
"NDCCode": "72143-221-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-221-30) ",
"NDC11Code": "72143-0221-30",
"ProductNDC": "72143-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200420",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "JG Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200420",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).",
"Description": "The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "72143-222-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-222-30) ",
"NDC11Code": "72143-0222-30",
"ProductNDC": "72143-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200420",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "JG Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200420",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).",
"Description": "The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "72143-223-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-223-30) ",
"NDC11Code": "72143-0223-30",
"ProductNDC": "72143-223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200420",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201922",
"LabelerName": "JG Pharma, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200420",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).",
"Description": "The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "72143-231-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-231-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-231-10) ",
"NDC11Code": "72143-0231-30",
"ProductNDC": "72143-231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"EndMarketingDate": "20231231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210111",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5."
},
{
"NDCCode": "72143-232-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-232-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-232-10) ",
"NDC11Code": "72143-0232-30",
"ProductNDC": "72143-232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210111",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "72143-233-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-233-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-233-10) ",
"NDC11Code": "72143-0233-30",
"ProductNDC": "72143-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210111",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210111",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5."
},
{
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"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-251-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "72143-0251-30",
"ProductNDC": "72143-251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
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"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
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"Status": "Active",
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"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "72143-252-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-252-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
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"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "72143-253-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-253-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "72143-0253-30",
"ProductNDC": "72143-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "72143-254-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72143-254-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "72143-0254-30",
"ProductNDC": "72143-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accutane",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202099",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).",
"Description": "Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5."
},
{
"NDCCode": "72143-321-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (72143-321-30) / 30 mL in 1 BOTTLE",
"NDC11Code": "72143-0321-30",
"ProductNDC": "72143-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulconazole Nitrate",
"NonProprietaryName": "Sulconazole Nitrate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200224",
"EndMarketingDate": "20281031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018738",
"LabelerName": "JG Pharma Inc.",
"SubstanceName": "SULCONAZOLE NITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200224",
"EndMarketingDatePackage": "20281031",
"SamplePackage": "N",
"IndicationAndUsage": "SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis;and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting SULCONAZOLE NITRATE topical solution and clinical improvement usually occurs within one week.",
"Description": "SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in SULCONAZOLE NITRATE topical solution, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[( p-cholorobenzyl)thio]phenethyl]imidazole mononitrate and it has the following chemical structure:. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. SULCONAZOLE NITRATE topical solution contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH."
},
{
"NDCCode": "10544-234-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, UNIT-DOSE (10544-234-30)",
"NDC11Code": "10544-0234-30",
"ProductNDC": "10544-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018858",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-17",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13709-234-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (13709-234-01) / 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "13709-0234-01",
"ProductNDC": "13709-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Netimist",
"NonProprietaryName": "Homeopathic Sinus Spray",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20160429",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "NeilMed Pharmaceuticals, Inc",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/30mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160429",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of : 1 Nasal Congestion, 2 Inflammation of mucous membranes , 3 Thick mucus & phlegm."
},
{
"NDCCode": "14783-234-01",
"PackageDescription": "30 g in 1 TUBE (14783-234-01) ",
"NDC11Code": "14783-0234-01",
"ProductNDC": "14783-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Obscure 8",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201112",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "2.44; 6.5; 1.57",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201112",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctorif rash occurs. ."
},
{
"NDCCode": "16590-234-30",
"PackageDescription": "30 g in 1 TUBE (16590-234-30)",
"NDC11Code": "16590-0234-30",
"ProductNDC": "16590-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19810409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086414",
"LabelerName": "STAT RX LLC USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Rx Only. The topical corticosteriods constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis (0xy)]-, (11β, 16α)-. C24H31FO6,M.W.:434.51; CAS Reg.No.:76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Ointment USP provides 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively in an ointment base of White Petrolatum and Light Mineral Oil."
},
{
"NDCCode": "21695-234-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-234-30)",
"NDC11Code": "21695-0234-30",
"ProductNDC": "21695-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Provigil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050603",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020717",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSAHS and SWSD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSAHS, or SWSD should periodically reevaluate long-term usefulness for the individual patient.",
"Description": "PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate."
},
{
"NDCCode": "24236-234-02",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (24236-234-02)",
"NDC11Code": "24236-0234-02",
"ProductNDC": "24236-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "29300-234-13",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-234-13) ",
"NDC11Code": "29300-0234-13",
"ProductNDC": "29300-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209261",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension , to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan, USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Valsartan, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, ferric oxide yellow (in 80 mg, and 160 mg), hypromellose, lactose monhydrate, magnesium stearate, microcrystalline cellulose, polyethelene glycol, povidone, sodium lauryl sulphate, talc (in 40 mg, and 320 mg) and titanium dioxide."
},
{
"NDCCode": "42571-234-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42571-234-30) ",
"NDC11Code": "42571-0234-30",
"ProductNDC": "42571-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207471",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).",
"Description": "Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide."
},
{
"NDCCode": "45865-234-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (45865-234-30) ",
"NDC11Code": "45865-0234-30",
"ProductNDC": "45865-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205129",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221212",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
},
{
"NDCCode": "46708-234-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (46708-234-30) ",
"NDC11Code": "46708-0234-30",
"ProductNDC": "46708-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vilazodone Hydrochloride",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208202",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220604",
"SamplePackage": "N",
"IndicationAndUsage": "Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Vilazodone hydrochloride tablets for oral administration contain vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is: In addition to the active ingredient, vilazodone hydrochloride tablets contain microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red No. # 40 Al Lake (10 mg only), FD&C Yellow No. # 6 Al Lake (20 mg only) and FD&C Blue No. # 1 Al Lake (40 mg only)."
},
{
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"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-234-02)",
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"ProductNDC": "49349-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-14"
},
{
"NDCCode": "50390-234-00",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50390-234-00) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "50390-0234-00",
"ProductNDC": "50390-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny",
"ProprietaryNameSuffix": "L3n1",
"NonProprietaryName": "Octinoxate, Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130506",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Amway Corp",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130506",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "51060-234-01",
"PackageDescription": "1 TUBE in 1 CARTON (51060-234-01) > 30 mL in 1 TUBE",
"NDC11Code": "51060-0234-01",
"ProductNDC": "51060-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sugar Rush Skin Treat Blurring Skin Tint Broad Spectrum Spf 20 Sunscreen",
"ProprietaryNameSuffix": "Rich",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190513",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tarte, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "45.5; 35",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190513",
"SamplePackage": "N"
},
{
"NDCCode": "51346-234-01",
"PackageDescription": "30 mL in 1 CARTON (51346-234-01) ",
"NDC11Code": "51346-0234-01",
"ProductNDC": "51346-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand And Nature Sanitizer",
"ProprietaryNameSuffix": "Aloe",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "16.41",
"StrengthUnit": "mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N"
},
{
"NDCCode": "51655-234-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-234-52) ",
"NDC11Code": "51655-0234-52",
"ProductNDC": "51655-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208709",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.",
"Description": "Fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum."
},
{
"NDCCode": "52125-234-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-234-02)",
"NDC11Code": "52125-0234-02",
"ProductNDC": "52125-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "52125-234-15",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-234-15)",
"NDC11Code": "52125-0234-15",
"ProductNDC": "52125-234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "54473-234-01",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 BOX (54473-234-01) > 30 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "54473-0234-01",
"ProductNDC": "54473-234",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sei Bella Age-defying Liquid Foundation",
"ProprietaryNameSuffix": "Golden",
"NonProprietaryName": "Octinoxate 7.5%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Melaleuca Inc.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "2.25",
"StrengthUnit": "g/30mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>72143-234-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (72143-234-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-234-10) </PackageDescription>
<NDC11Code>72143-0234-30</NDC11Code>
<ProductNDC>72143-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accutane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>JG Pharma Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5.</Description>
</NDC>
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<NDCCode>72143-221-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-221-30) </PackageDescription>
<NDC11Code>72143-0221-30</NDC11Code>
<ProductNDC>72143-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>JG Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).</IndicationAndUsage>
<Description>The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72143-222-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-222-30) </PackageDescription>
<NDC11Code>72143-0222-30</NDC11Code>
<ProductNDC>72143-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>JG Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).</IndicationAndUsage>
<Description>The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72143-223-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72143-223-30) </PackageDescription>
<NDC11Code>72143-0223-30</NDC11Code>
<ProductNDC>72143-223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201922</ApplicationNumber>
<LabelerName>JG Pharma, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release capsules is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1). Limitations of Use. Minocycline hydrochloride extended-release capsules did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release capsules has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. (14).</IndicationAndUsage>
<Description>The active ingredient in minocycline hydrochloride extended-release capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Minocycline hydrochloride extended-release capsules is a tetracycline-class drug. Minocycline hydrochloride extended-release capsules is known chemically as [4 S‑(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below. Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether. Minocycline hydrochloride extended-release capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide. The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc. Minocycline hydrochloride extended-release capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72143-231-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (72143-231-30) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-231-10) </PackageDescription>
<NDC11Code>72143-0231-30</NDC11Code>
<ProductNDC>72143-231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accutane</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<EndMarketingDate>20231231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202099</ApplicationNumber>
<LabelerName>JG Pharma Inc.</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5.</Description>
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<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containingD&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titaniumdioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP Dissolution Test 5.</Description>
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<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
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<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
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<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
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<IndicationAndUsage>Severe Recalcitrant Nodular Acne. Accutane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.In addition, Accutane is indicated only for those patients who are not pregnant, because Accutane can cause life-threatening birth defects (see BoxedCONTRAINDICATIONSAND WARNINGS). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure).</IndicationAndUsage>
<Description>Isotretinoin USP, a retinoid, is available as Accutane (isotretinoin capsules, USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylatedhydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain ferric oxide red, ferricoxide yellow (for 30 mg), gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to slightly orange crystalline powder with a molecular weight of 300.44. The structural formula is. Meets USP DissolutionTest 5.</Description>
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<LabelerName>JG Pharma Inc.</LabelerName>
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<IndicationAndUsage>SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,and Microsporum canis;and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting SULCONAZOLE NITRATE topical solution and clinical improvement usually occurs within one week.</IndicationAndUsage>
<Description>SULCONAZOLE NITRATE topical solution 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in SULCONAZOLE NITRATE topical solution, is an imidazole derivative with antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[( p-cholorobenzyl)thio]phenethyl]imidazole mononitrate and it has the following chemical structure:. Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. SULCONAZOLE NITRATE topical solution contains sulconazole nitrate, USP 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.</Description>
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<RouteName>NASAL</RouteName>
<StartMarketingDate>20160429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>NeilMed Pharmaceuticals, Inc</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of : 1 Nasal Congestion, 2 Inflammation of mucous membranes , 3 Thick mucus & phlegm.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14783-234-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (14783-234-01) </PackageDescription>
<NDC11Code>14783-0234-01</NDC11Code>
<ProductNDC>14783-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 15 Obscure 8</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.44; 6.5; 1.57</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctorif rash occurs. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-234-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (16590-234-30)</PackageDescription>
<NDC11Code>16590-0234-30</NDC11Code>
<ProductNDC>16590-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19810409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086414</ApplicationNumber>
<LabelerName>STAT RX LLC USA</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Rx Only. The topical corticosteriods constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis (0xy)]-, (11β, 16α)-. C24H31FO6,M.W.:434.51; CAS Reg.No.:76-25-5. Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Ointment USP provides 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively in an ointment base of White Petrolatum and Light Mineral Oil.</Description>
</NDC>
<NDC>
<NDCCode>21695-234-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-234-30)</PackageDescription>
<NDC11Code>21695-0234-30</NDC11Code>
<ProductNDC>21695-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Provigil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050603</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020717</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness. The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSAHS and SWSD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSAHS, or SWSD should periodically reevaluate long-term usefulness for the individual patient.</IndicationAndUsage>
<Description>PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>24236-234-02</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (24236-234-02)</PackageDescription>
<NDC11Code>24236-0234-02</NDC11Code>
<ProductNDC>24236-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>29300-234-13</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-234-13) </PackageDescription>
<NDC11Code>29300-0234-13</NDC11Code>
<ProductNDC>29300-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209261</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension , to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan, USP is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white or almost white, hygroscopic powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, practically insoluble in water. Valsartan, USP is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, ferric oxide yellow (in 80 mg, and 160 mg), hypromellose, lactose monhydrate, magnesium stearate, microcrystalline cellulose, polyethelene glycol, povidone, sodium lauryl sulphate, talc (in 40 mg, and 320 mg) and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42571-234-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42571-234-30) </PackageDescription>
<NDC11Code>42571-0234-30</NDC11Code>
<ProductNDC>42571-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207471</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
<Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45865-234-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (45865-234-30) </PackageDescription>
<NDC11Code>45865-0234-30</NDC11Code>
<ProductNDC>45865-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205129</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>46708-234-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (46708-234-30) </PackageDescription>
<NDC11Code>46708-0234-30</NDC11Code>
<ProductNDC>46708-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vilazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208202</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Vilazodone hydrochloride tablets for oral administration contain vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is: In addition to the active ingredient, vilazodone hydrochloride tablets contain microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red No. # 40 Al Lake (10 mg only), FD&C Yellow No. # 6 Al Lake (20 mg only) and FD&C Blue No. # 1 Al Lake (40 mg only).</Description>
</NDC>
<NDC>
<NDCCode>49349-234-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-234-02)</PackageDescription>
<NDC11Code>49349-0234-02</NDC11Code>
<ProductNDC>49349-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>50390-234-00</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50390-234-00) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50390-0234-00</NDC11Code>
<ProductNDC>50390-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny</ProprietaryName>
<ProprietaryNameSuffix>L3n1</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130506</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Amway Corp</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51060-234-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51060-234-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>51060-0234-01</NDC11Code>
<ProductNDC>51060-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sugar Rush Skin Treat Blurring Skin Tint Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Rich</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tarte, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>45.5; 35</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51346-234-01</NDCCode>
<PackageDescription>30 mL in 1 CARTON (51346-234-01) </PackageDescription>
<NDC11Code>51346-0234-01</NDC11Code>
<ProductNDC>51346-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand And Nature Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>16.41</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51655-234-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-234-52) </PackageDescription>
<NDC11Code>51655-0234-52</NDC11Code>
<ProductNDC>51655-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208709</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets are indicated as adjunctive therapy to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.</IndicationAndUsage>
<Description>Fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain. 48 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets. polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>52125-234-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-234-02)</PackageDescription>
<NDC11Code>52125-0234-02</NDC11Code>
<ProductNDC>52125-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-234-15</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-234-15)</PackageDescription>
<NDC11Code>52125-0234-15</NDC11Code>
<ProductNDC>52125-234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>54473-234-01</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 BOX (54473-234-01) > 30 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>54473-0234-01</NDC11Code>
<ProductNDC>54473-234</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sei Bella Age-defying Liquid Foundation</ProprietaryName>
<ProprietaryNameSuffix>Golden</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate 7.5%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Melaleuca Inc.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>2.25</StrengthNumber>
<StrengthUnit>g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>