{
"NDC": [
{
"NDCCode": "84386-087-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-087-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0087-03",
"ProductNDC": "84386-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-087-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-087-30) ",
"NDC11Code": "84386-0087-30",
"ProductNDC": "84386-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-009-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-009-03) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "84386-0009-03",
"ProductNDC": "84386-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220336",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use:. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin Capsules, USP contain 20 mg, 30 mg, and 40 mg of isotretinoin, USP (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil and white wax. The hard gelatin capsules contain the following dye systems: : 1 20 mg – gelatin, iron oxide (black and red), FD&C yellow 6 and titanium dioxide;, 2 30 mg – gelatin, iron oxide (red and yellow) and titanium dioxide;, 3 40 mg – gelatin, FD&C yellow 6, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "84386-010-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-010-03) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "84386-0010-03",
"ProductNDC": "84386-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220336",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use:. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin Capsules, USP contain 20 mg, 30 mg, and 40 mg of isotretinoin, USP (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil and white wax. The hard gelatin capsules contain the following dye systems: : 1 20 mg – gelatin, iron oxide (black and red), FD&C yellow 6 and titanium dioxide;, 2 30 mg – gelatin, iron oxide (red and yellow) and titanium dioxide;, 3 40 mg – gelatin, FD&C yellow 6, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "84386-011-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-011-03) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "84386-0011-03",
"ProductNDC": "84386-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220336",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260910",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use:. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin Capsules, USP contain 20 mg, 30 mg, and 40 mg of isotretinoin, USP (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil and white wax. The hard gelatin capsules contain the following dye systems: : 1 20 mg – gelatin, iron oxide (black and red), FD&C yellow 6 and titanium dioxide;, 2 30 mg – gelatin, iron oxide (red and yellow) and titanium dioxide;, 3 40 mg – gelatin, FD&C yellow 6, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "84386-084-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-084-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0084-03",
"ProductNDC": "84386-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-085-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-085-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0085-03",
"ProductNDC": "84386-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-086-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-086-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0086-03",
"ProductNDC": "84386-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-088-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-088-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0088-03",
"ProductNDC": "84386-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
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"ProductNDC": "84386-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
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"StartMarketingDatePackage": "20261002",
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"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
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{
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"NDC11Code": "25000-0087-03",
"ProductNDC": "25000-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Famotidine 20 Mg",
"NonProprietaryName": "Famotidine 20 Mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230310",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach."
},
{
"NDCCode": "37808-087-03",
"PackageDescription": "1 TUBE in 1 CARTON (37808-087-03) / 150 g in 1 TUBE",
"NDC11Code": "37808-0087-03",
"ProductNDC": "37808-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthritis Pain Reliever",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211253",
"LabelerName": "H E B",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201118",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas:. hand, wrist, elbow (upper body areas). foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "58159-087-03",
"PackageDescription": "15 kg in 1 DRUM (58159-087-03) ",
"NDC11Code": "58159-0087-03",
"ProductNDC": "58159-087",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cevimeline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210706",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "CEVIMELINE HYDROCHLORIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2021-07-15",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "06-JUL-21"
},
{
"NDCCode": "60290-087-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-087-03) ",
"NDC11Code": "60290-0087-03",
"ProductNDC": "60290-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219946",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260810",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .",
"Description": "Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1 S,3 R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis( N-pentanoyl- N-{[2´-(1 H-tetrazol-1-id-5- yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48H 57N 6O 8Na 3. Its molecular mass is 914.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red, macrogol, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "63545-087-03",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (63545-087-03) ",
"NDC11Code": "63545-0087-03",
"ProductNDC": "63545-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Araneus Diadematus",
"NonProprietaryName": "Araneus Diadematus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210225",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARANEUS DIADEMATUS",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210225",
"SamplePackage": "N"
},
{
"NDCCode": "73102-087-03",
"PackageDescription": "1 JAR in 1 BOX (73102-087-03) > 89 mL in 1 JAR",
"NDC11Code": "73102-0087-03",
"ProductNDC": "73102-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Minted Leaf Cold Therapy Menthol Relief With Cbd",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200417",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "MMG Consumer Brands, LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200417",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "75929-087-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (75929-087-03) ",
"NDC11Code": "75929-0087-03",
"ProductNDC": "75929-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aricept",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022568",
"LabelerName": "Pharma Packaging Solutions, LLC dba Tjoapack LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100723",
"SamplePackage": "N",
"IndicationAndUsage": "ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ARICEPT is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide. ARICEPT ODT tablets are available for oral administration. Each ARICEPT ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent."
},
{
"NDCCode": "76420-087-03",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (76420-087-03) > 3 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "76420-0087-03",
"ProductNDC": "76420-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074880",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2020-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201016",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.",
"Description": "Albuterol sulfate inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α′-diol sulfate (2:1) (salt) and the following structural formula:. Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents. Albuterol sulfate inhalation solution is a clear, colorless solution."
},
{
"NDCCode": "84864-087-03",
"PackageDescription": "30 g in 1 BOX (84864-087-03) ",
"NDC11Code": "84864-0087-03",
"ProductNDC": "84864-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stretch Mark Cream",
"NonProprietaryName": "Stretch Mark Cream",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Jingmo trade Co., LTD",
"SubstanceName": "COPPER TRIPEPTIDE-1",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply to skin until absorbed."
},
{
"NDCCode": "10135-708-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-708-01) ",
"NDC11Code": "10135-0708-01",
"ProductNDC": "10135-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "10135-708-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (10135-708-50) ",
"NDC11Code": "10135-0708-50",
"ProductNDC": "10135-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "10135-709-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-709-01) ",
"NDC11Code": "10135-0709-01",
"ProductNDC": "10135-709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "10135-709-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (10135-709-05) ",
"NDC11Code": "10135-0709-05",
"ProductNDC": "10135-709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "10135-710-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-710-01) ",
"NDC11Code": "10135-0710-01",
"ProductNDC": "10135-710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "10135-710-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (10135-710-05) ",
"NDC11Code": "10135-0710-05",
"ProductNDC": "10135-710",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202297",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
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"ApplicationNumber": "ANDA209796",
"LabelerName": "NorthStar RxLLC",
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"IndicationAndUsage": "Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.",
"Description": "Table 4. Description. Clobazam is a white or almost white crystalline powder; is freely soluble in dichloromethane. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13ClN 2O 2 and the molecular weight is 300.74. Clobazam is available for oral administration as an off white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include citric acid monohydrate, dibasic sodium phosphate anhydrous, magnesium aluminum silicate, maltitol solution, methylparaben, polysorbate 80, propylene glycol, propyl paraben, purified water, simethicone emulsion, strawberry flavor, sucralose and xanthan gum."
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{
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"NonProprietaryName": "Metoprolol Succinate And Hydrochlorothiazide",
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{
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"LabelerName": "Covis Pharmaceuticals Inc",
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"Status": "Deprecated",
"LastUpdate": "2017-02-03"
},
{
"NDCCode": "29300-135-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (29300-135-01) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078895",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
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"NDC11Code": "29300-0135-05",
"ProductNDC": "29300-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA078895",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
}
]
}
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<Description>Chemically, isotretinoin USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin Capsules, USP contain 20 mg, 30 mg, and 40 mg of isotretinoin, USP (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil and white wax. The hard gelatin capsules contain the following dye systems: : 1 20 mg – gelatin, iron oxide (black and red), FD&C yellow 6 and titanium dioxide;, 2 30 mg – gelatin, iron oxide (red and yellow) and titanium dioxide;, 3 40 mg – gelatin, FD&C yellow 6, sodium lauryl sulfate and titanium dioxide.</Description>
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<Description>Chemically, isotretinoin USP is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light-orange, crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin Capsules, USP contain 20 mg, 30 mg, and 40 mg of isotretinoin, USP (a retinoid) for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil and white wax. The hard gelatin capsules contain the following dye systems: : 1 20 mg – gelatin, iron oxide (black and red), FD&C yellow 6 and titanium dioxide;, 2 30 mg – gelatin, iron oxide (red and yellow) and titanium dioxide;, 3 40 mg – gelatin, FD&C yellow 6, sodium lauryl sulfate and titanium dioxide.</Description>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (84386-084-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (84386-085-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (84386-086-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-088-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (84386-088-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>84386-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-089-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (84386-089-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>84386-0089-03</NDC11Code>
<ProductNDC>84386-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>25000-087-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25000-087-03) / 30 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>25000-0087-03</NDC11Code>
<ProductNDC>25000-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine 20 Mg</ProprietaryName>
<NonProprietaryName>Famotidine 20 Mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach.</IndicationAndUsage>
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<NDC>
<NDCCode>37808-087-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37808-087-03) / 150 g in 1 TUBE</PackageDescription>
<NDC11Code>37808-0087-03</NDC11Code>
<ProductNDC>37808-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthritis Pain Reliever</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211253</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas:. hand, wrist, elbow (upper body areas). foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58159-087-03</NDCCode>
<PackageDescription>15 kg in 1 DRUM (58159-087-03) </PackageDescription>
<NDC11Code>58159-0087-03</NDC11Code>
<ProductNDC>58159-087</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cevimeline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210706</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>NURAY CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>CEVIMELINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-07-15</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60290-087-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60290-087-03) </PackageDescription>
<NDC11Code>60290-0087-03</NDC11Code>
<ProductNDC>60290-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219946</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1) , 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2) .</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Octadecasodiumhexakis(4-{[(1 S,3 R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis( N-pentanoyl- N-{[2´-(1 H-tetrazol-1-id-5- yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C 48H 57N 6O 8Na 3. Its molecular mass is 914.97 g/mol and its schematic structural formula is:. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc. The film-coat inactive ingredients are hypromellose, iron oxide red, macrogol, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>63545-087-03</NDCCode>
<PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (63545-087-03) </PackageDescription>
<NDC11Code>63545-0087-03</NDC11Code>
<ProductNDC>63545-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Araneus Diadematus</ProprietaryName>
<NonProprietaryName>Araneus Diadematus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARANEUS DIADEMATUS</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73102-087-03</NDCCode>
<PackageDescription>1 JAR in 1 BOX (73102-087-03) > 89 mL in 1 JAR</PackageDescription>
<NDC11Code>73102-0087-03</NDC11Code>
<ProductNDC>73102-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Minted Leaf Cold Therapy Menthol Relief With Cbd</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200417</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>MMG Consumer Brands, LLC</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200417</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>75929-087-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (75929-087-03) </PackageDescription>
<NDC11Code>75929-0087-03</NDC11Code>
<ProductNDC>75929-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aricept</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022568</ApplicationNumber>
<LabelerName>Pharma Packaging Solutions, LLC dba Tjoapack LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARICEPT is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>ARICEPT (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. ARICEPT is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose, and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose 2910, polyethylene glycol 8000, talc, and titanium dioxide. ARICEPT ODT tablets are available for oral administration. Each ARICEPT ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.</Description>
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<NDC>
<NDCCode>76420-087-03</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (76420-087-03) > 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>76420-0087-03</NDC11Code>
<ProductNDC>76420-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19970917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074880</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
<Description>Albuterol sulfate inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α′-diol sulfate (2:1) (salt) and the following structural formula:. Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents. Albuterol sulfate inhalation solution is a clear, colorless solution.</Description>
</NDC>
<NDC>
<NDCCode>84864-087-03</NDCCode>
<PackageDescription>30 g in 1 BOX (84864-087-03) </PackageDescription>
<NDC11Code>84864-0087-03</NDC11Code>
<ProductNDC>84864-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stretch Mark Cream</ProprietaryName>
<NonProprietaryName>Stretch Mark Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Jingmo trade Co., LTD</LabelerName>
<SubstanceName>COPPER TRIPEPTIDE-1</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply to skin until absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10135-708-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-708-01) </PackageDescription>
<NDC11Code>10135-0708-01</NDC11Code>
<ProductNDC>10135-708</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10135-708-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10135-708-50) </PackageDescription>
<NDC11Code>10135-0708-50</NDC11Code>
<ProductNDC>10135-708</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10135-709-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-709-01) </PackageDescription>
<NDC11Code>10135-0709-01</NDC11Code>
<ProductNDC>10135-709</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10135-709-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10135-709-05) </PackageDescription>
<NDC11Code>10135-0709-05</NDC11Code>
<ProductNDC>10135-709</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10135-710-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-710-01) </PackageDescription>
<NDC11Code>10135-0710-01</NDC11Code>
<ProductNDC>10135-710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10135-710-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10135-710-05) </PackageDescription>
<NDC11Code>10135-0710-05</NDC11Code>
<ProductNDC>10135-710</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202297</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths:. 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, lactose monohydrate and magnesium stearate. In addition, the 0.1 mg tablets contain FD&C Red No. 40, and the 0.2 mg and 0.3 mg tablets contain FD&C Yellow No. 6 as color additives respectively. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>16714-087-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>16714-0087-01</NDC11Code>
<ProductNDC>16714-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobazam</ProprietaryName>
<NonProprietaryName>Clobazam</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209796</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CLOBAZAM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.</IndicationAndUsage>
<Description>Table 4. Description. Clobazam is a white or almost white crystalline powder; is freely soluble in dichloromethane. The melting range of clobazam is from 182ºC to 185ºC. The molecular formula is C 16H 13ClN 2O 2 and the molecular weight is 300.74. Clobazam is available for oral administration as an off white suspension containing clobazam at a concentration of 2.5 mg/mL. Inactive ingredients include citric acid monohydrate, dibasic sodium phosphate anhydrous, magnesium aluminum silicate, maltitol solution, methylparaben, polysorbate 80, propylene glycol, propyl paraben, purified water, simethicone emulsion, strawberry flavor, sucralose and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>24987-087-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (24987-087-30)</PackageDescription>
<NDC11Code>24987-0087-30</NDC11Code>
<ProductNDC>24987-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dutoprol</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<EndMarketingDate>20170131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021956</ApplicationNumber>
<LabelerName>Covis Pharmaceuticals Inc</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>24987-087-95</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (24987-087-95)</PackageDescription>
<NDC11Code>24987-0087-95</NDC11Code>
<ProductNDC>24987-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dutoprol</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140701</StartMarketingDate>
<EndMarketingDate>20170131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021956</ApplicationNumber>
<LabelerName>Covis Pharmaceuticals Inc</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>29300-135-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (29300-135-01) </PackageDescription>
<NDC11Code>29300-0135-01</NDC11Code>
<ProductNDC>29300-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078895</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>29300-135-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (29300-135-05) </PackageDescription>
<NDC11Code>29300-0135-05</NDC11Code>
<ProductNDC>29300-135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078895</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, sodium starch glycolate, glycerin, lactose monohydrate, magnesium stearate, povidone. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
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