{
"NDC": [
{
"NDCCode": "99207-525-30",
"PackageDescription": "1 TUBE in 1 CARTON (99207-525-30) / 30 g in 1 TUBE",
"NDC11Code": "99207-0525-30",
"ProductNDC": "99207-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanos",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060313",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021758",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060313",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "VANOS Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. (1.2).",
"Description": "VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP."
},
{
"NDCCode": "99207-525-02",
"PackageDescription": "20 TUBE in 1 CARTON (99207-525-02) > 1.5 g in 1 TUBE",
"NDC11Code": "99207-0525-02",
"ProductNDC": "99207-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanos",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060313",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021758",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20060313",
"SamplePackage": "N"
},
{
"NDCCode": "99207-525-10",
"PackageDescription": "1 TUBE in 1 CARTON (99207-525-10) / 120 g in 1 TUBE",
"NDC11Code": "99207-0525-10",
"ProductNDC": "99207-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanos",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060313",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021758",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060313",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "VANOS Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. (1.2).",
"Description": "VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP."
},
{
"NDCCode": "99207-525-60",
"PackageDescription": "1 TUBE in 1 CARTON (99207-525-60) / 60 g in 1 TUBE",
"NDC11Code": "99207-0525-60",
"ProductNDC": "99207-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanos",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060313",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021758",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060313",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "VANOS Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. (1.2).",
"Description": "VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP."
},
{
"NDCCode": "99207-013-30",
"PackageDescription": "1 TUBE in 1 CARTON (99207-013-30) > 30 g in 1 TUBE",
"NDC11Code": "99207-0013-30",
"ProductNDC": "99207-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Loprox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050501",
"EndMarketingDate": "20140228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020519",
"LabelerName": "Medicis Pharmaceutical Corp",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "99207-170-02",
"PackageDescription": "30 PATCH in 1 CARTON (99207-170-02) ",
"NDC11Code": "99207-0170-02",
"ProductNDC": "99207-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20120221",
"EndMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089771",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120221",
"EndMarketingDatePackage": "20211001",
"SamplePackage": "N"
},
{
"NDCCode": "99207-171-05",
"PackageDescription": "30 PATCH in 1 CARTON (99207-171-05) ",
"NDC11Code": "99207-0171-05",
"ProductNDC": "99207-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20120221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089772",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120221",
"SamplePackage": "N"
},
{
"NDCCode": "99207-172-10",
"PackageDescription": "30 PATCH in 1 CARTON (99207-172-10) ",
"NDC11Code": "99207-0172-10",
"ProductNDC": "99207-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20120221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089773",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120221",
"SamplePackage": "N"
},
{
"NDCCode": "99207-173-15",
"PackageDescription": "30 PATCH in 1 CARTON (99207-173-15) ",
"NDC11Code": "99207-0173-15",
"ProductNDC": "99207-173",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20120221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089774",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20120221",
"SamplePackage": "N"
},
{
"NDCCode": "99207-300-30",
"PackageDescription": "1 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBE",
"NDC11Code": "99207-0300-30",
"ProductNDC": "99207-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziana",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20061201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050802",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "12; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20061201",
"SamplePackage": "N",
"IndicationAndUsage": "ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate:Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is 3,7-Dimethyl- 9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8 nonatetraenoic acid (all-trans form). The structural formula for tretinoin is represented below. Tretinoin. Molecular Formula: C20H28O2 Molecular Weight: 300.44. ZIANA Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP."
},
{
"NDCCode": "99207-460-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-460-30)",
"NDC11Code": "99207-0460-30",
"ProductNDC": "99207-460",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060508",
"EndMarketingDate": "20140228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Medicis Pharmaceutical Corp.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "99207-462-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-462-30)",
"NDC11Code": "99207-0462-30",
"ProductNDC": "99207-462",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060508",
"EndMarketingDate": "20140228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Medicis Pharmaceutical Corp.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "99207-463-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-463-30) ",
"NDC11Code": "99207-0463-30",
"ProductNDC": "99207-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "65",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090723",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "99207-464-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-464-30) ",
"NDC11Code": "99207-0464-30",
"ProductNDC": "99207-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "115",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090723",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "99207-465-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-465-30) ",
"NDC11Code": "99207-0465-30",
"ProductNDC": "99207-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100927",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "99207-466-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-466-30) ",
"NDC11Code": "99207-0466-30",
"ProductNDC": "99207-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100927",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "99207-467-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-467-30) ",
"NDC11Code": "99207-0467-30",
"ProductNDC": "99207-467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solodyn",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050808",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "105",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100927",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).",
"Description": "Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2."
},
{
"NDCCode": "99207-500-30",
"PackageDescription": "1 VIAL in 1 CARTON (99207-500-30) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "99207-0500-30",
"ProductNDC": "99207-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dysport",
"NonProprietaryName": "Botulinum Toxin Type A",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090525",
"EndMarketingDate": "20150331",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125274",
"LabelerName": "Medicis Pharmaceutical Corp",
"SubstanceName": "BOTULINUM TOXIN TYPE A",
"StrengthNumber": "300",
"StrengthUnit": "[USP&apos'U]/1",
"Pharm_Classes": "Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-04-03"
},
{
"NDCCode": "99207-850-30",
"PackageDescription": "1 TUBE in 1 CARTON (99207-850-30) > 30 g in 1 TUBE",
"NDC11Code": "99207-0850-30",
"ProductNDC": "99207-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Luzu",
"NonProprietaryName": "Luliconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204153",
"LabelerName": "Medicis Pharmaceutical Corp.",
"SubstanceName": "LULICONAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-01-09"
},
{
"NDCCode": "12634-525-71",
"PackageDescription": "30 TABLET in 1 BOTTLE (12634-525-71)",
"NDC11Code": "12634-0525-71",
"ProductNDC": "12634-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074215",
"LabelerName": "Apotheca, Inc",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES ). Panic Disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. INACTIVE INGREDIENT. Corn starch, lactose monohydrate, sodium starch glycolate, hypromellose, colloidal silicon dioxide, magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "17139-525-30",
"PackageDescription": "30 PACKET in 1 CARTON (17139-525-30) / 2.5 g in 1 PACKET",
"NDC11Code": "17139-0525-30",
"ProductNDC": "17139-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Androgel",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20230217",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021015",
"LabelerName": "ASCEND Therapeutics U.S., LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230217",
"SamplePackage": "N",
"IndicationAndUsage": "AndroGel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .",
"Description": "AndroGel 1% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active."
},
{
"NDCCode": "31722-525-30",
"PackageDescription": "12 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "31722-0525-30",
"ProductNDC": "31722-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090061",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150613",
"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).",
"Description": "Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize."
},
{
"NDCCode": "33342-525-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-525-07) ",
"NDC11Code": "33342-0525-07",
"ProductNDC": "33342-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218744",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230623",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "35356-525-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-525-30) ",
"NDC11Code": "35356-0525-30",
"ProductNDC": "35356-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nucynta",
"NonProprietaryName": "Tapentadol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100929",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022304",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "TAPENTADOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100929",
"SamplePackage": "N"
},
{
"NDCCode": "43063-525-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-525-30)",
"NDC11Code": "43063-0525-30",
"ProductNDC": "43063-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075994",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "43547-525-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-525-03) ",
"NDC11Code": "43547-0525-03",
"ProductNDC": "43547-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "49349-525-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-525-02)",
"NDC11Code": "49349-0525-02",
"ProductNDC": "49349-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Hydrochloride",
"NonProprietaryName": "Imipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083745",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "51407-525-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (51407-525-30) ",
"NDC11Code": "51407-0525-30",
"ProductNDC": "51407-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074569",
"LabelerName": "Golden State Medical Supply Inc.",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180220",
"SamplePackage": "N"
},
{
"NDCCode": "52125-525-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 VIAL (52125-525-02)",
"NDC11Code": "52125-0525-02",
"ProductNDC": "52125-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avelox",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021085",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "55111-525-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-525-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0525-30",
"ProductNDC": "55111-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
}
]
}
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<LastUpdate>2026-09-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Description>VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.</Description>
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<PackageDescription>20 TUBE in 1 CARTON (99207-525-02) > 1.5 g in 1 TUBE</PackageDescription>
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<StrengthUnit>mg/g</StrengthUnit>
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<LastUpdate>2021-02-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>99207-525-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (99207-525-10) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>99207-0525-10</NDC11Code>
<ProductNDC>99207-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060313</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
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<Description>VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.</Description>
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<NDC>
<NDCCode>99207-525-60</NDCCode>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060313</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VANOS Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1). Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea. (1.2).</IndicationAndUsage>
<Description>VANOS (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of VANOS Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.</Description>
</NDC>
<NDC>
<NDCCode>99207-013-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (99207-013-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>99207-0013-30</NDC11Code>
<ProductNDC>99207-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Loprox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050501</StartMarketingDate>
<EndMarketingDate>20140228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020519</ApplicationNumber>
<LabelerName>Medicis Pharmaceutical Corp</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>99207-170-02</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (99207-170-02) </PackageDescription>
<NDC11Code>99207-0170-02</NDC11Code>
<ProductNDC>99207-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
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<StartMarketingDate>20120221</StartMarketingDate>
<EndMarketingDate>20211001</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089771</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120221</StartMarketingDatePackage>
<EndMarketingDatePackage>20211001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>99207-171-05</NDCCode>
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<NDC11Code>99207-0171-05</NDC11Code>
<ProductNDC>99207-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
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<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20120221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089772</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>99207-172-10</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (99207-172-10) </PackageDescription>
<NDC11Code>99207-0172-10</NDC11Code>
<ProductNDC>99207-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089773</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>99207-173-15</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (99207-173-15) </PackageDescription>
<NDC11Code>99207-0173-15</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
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<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089774</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>99207-300-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>99207-0300-30</NDC11Code>
<ProductNDC>99207-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziana</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20061201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050802</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>12; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate:Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is 3,7-Dimethyl- 9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8 nonatetraenoic acid (all-trans form). The structural formula for tretinoin is represented below. Tretinoin. Molecular Formula: C20H28O2 Molecular Weight: 300.44. ZIANA Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP.</Description>
</NDC>
<NDC>
<NDCCode>99207-460-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-460-30)</PackageDescription>
<NDC11Code>99207-0460-30</NDC11Code>
<ProductNDC>99207-460</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060508</StartMarketingDate>
<EndMarketingDate>20140228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Medicis Pharmaceutical Corp.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>99207-462-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-462-30)</PackageDescription>
<NDC11Code>99207-0462-30</NDC11Code>
<ProductNDC>99207-462</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060508</StartMarketingDate>
<EndMarketingDate>20140228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Medicis Pharmaceutical Corp.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>99207-463-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-463-30) </PackageDescription>
<NDC11Code>99207-0463-30</NDC11Code>
<ProductNDC>99207-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090723</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>99207-464-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-464-30) </PackageDescription>
<NDC11Code>99207-0464-30</NDC11Code>
<ProductNDC>99207-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>115</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>99207-465-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-465-30) </PackageDescription>
<NDC11Code>99207-0465-30</NDC11Code>
<ProductNDC>99207-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>99207-466-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-466-30) </PackageDescription>
<NDC11Code>99207-0466-30</NDC11Code>
<ProductNDC>99207-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>99207-467-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (99207-467-30) </PackageDescription>
<NDC11Code>99207-0467-30</NDC11Code>
<ProductNDC>99207-467</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solodyn</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050808</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLODYN is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1).</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi-synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. SOLODYN Tablets for oral administration contain minocycline hydrochloride USP equivalent to 55 mg, 65 mg, 80 mg, 105 mg, or 115 mg of minocycline. In addition, 55 mg, 65 mg, 80 mg, 105 mg, and 115 mg tablets contain the following inactive ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 55 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, titanium dioxide USP, lactose monohydrate NF, polyethylene glycol 3350 NF, triacetin USP, and FD&C Red #40. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 80 mg tablets also contain Opadry II Gray which contains: hypromellose type 2910 USP, lactose monohydrate NF, polyethylene glycol 3350 NF, FD&C Blue #2, FD&C Red #40, titanium dioxide USP, triacetin USP, and FD&C Yellow #6. The 105 mg tablets also contain Opadry II Purple which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, D&C Red #27, polyethylene glycol 3350 NF, triacetin USP, and FD&C Blue #1. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>99207-500-30</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (99207-500-30) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>99207-0500-30</NDC11Code>
<ProductNDC>99207-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dysport</ProprietaryName>
<NonProprietaryName>Botulinum Toxin Type A</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20090525</StartMarketingDate>
<EndMarketingDate>20150331</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125274</ApplicationNumber>
<LabelerName>Medicis Pharmaceutical Corp</LabelerName>
<SubstanceName>BOTULINUM TOXIN TYPE A</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[USP&apos'U]/1</StrengthUnit>
<Pharm_Classes>Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>99207-850-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (99207-850-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>99207-0850-30</NDC11Code>
<ProductNDC>99207-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Luzu</ProprietaryName>
<NonProprietaryName>Luliconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204153</ApplicationNumber>
<LabelerName>Medicis Pharmaceutical Corp.</LabelerName>
<SubstanceName>LULICONAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-01-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>12634-525-71</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (12634-525-71)</PackageDescription>
<NDC11Code>12634-0525-71</NDC11Code>
<ProductNDC>12634-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074215</ApplicationNumber>
<LabelerName>Apotheca, Inc</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES ). Panic Disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented below. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. INACTIVE INGREDIENT. Corn starch, lactose monohydrate, sodium starch glycolate, hypromellose, colloidal silicon dioxide, magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>17139-525-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (17139-525-30) / 2.5 g in 1 PACKET</PackageDescription>
<NDC11Code>17139-0525-30</NDC11Code>
<ProductNDC>17139-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Androgel</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20230217</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021015</ApplicationNumber>
<LabelerName>ASCEND Therapeutics U.S., LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AndroGel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .</IndicationAndUsage>
<Description>AndroGel 1% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.</Description>
</NDC>
<NDC>
<NDCCode>31722-525-30</NDCCode>
<PackageDescription>12 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0525-30</NDC11Code>
<ProductNDC>31722-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090061</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets, are a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms Reduce the risk of acute urinary retention Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2). Limitations of Use:Finasteride tablets are not approved for the prevention of prostate cancer (1.3).</IndicationAndUsage>
<Description>Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-, (5α,17β)-. The empirical formula of finasteride is C 23H 36N 2O 2and its molecular weight is 372.55. Its structural formula is:. Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize.</Description>
</NDC>
<NDC>
<NDCCode>33342-525-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-525-07) </PackageDescription>
<NDC11Code>33342-0525-07</NDC11Code>
<ProductNDC>33342-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218744</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3¬ (acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: acetyl tributyl citrate, Ethyl Cellulose, hydroxypropyl methyl cellulose (Methocel E3 Premium LV), hydroxypropyl methyl cellulose (Methocel E5 Premium LV), microcrystalline cellulose, Talc. The capsule shells contain FD&C Blue #1, gelatin and titanium dioxide black iron oxide (300 mg). The capsules are imprinted with black TekPrint TM SW-0012 White Ink or TekPrint TM SB-6018 Blue Ink which contains FD & C Blue # 2 Aluminum Lake - E 132, potassium hydroxide, propylene glycol, titanium Dioxide and shellac. For oral administration. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>35356-525-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-525-30) </PackageDescription>
<NDC11Code>35356-0525-30</NDC11Code>
<ProductNDC>35356-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nucynta</ProprietaryName>
<NonProprietaryName>Tapentadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100929</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022304</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>TAPENTADOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-525-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-525-30)</PackageDescription>
<NDC11Code>43063-0525-30</NDC11Code>
<ProductNDC>43063-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075994</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43547-525-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-525-03) </PackageDescription>
<NDC11Code>43547-0525-03</NDC11Code>
<ProductNDC>43547-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>49349-525-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-525-02)</PackageDescription>
<NDC11Code>49349-0525-02</NDC11Code>
<ProductNDC>49349-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Imipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083745</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>51407-525-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (51407-525-30) </PackageDescription>
<NDC11Code>51407-0525-30</NDC11Code>
<ProductNDC>51407-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074569</ApplicationNumber>
<LabelerName>Golden State Medical Supply Inc.</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52125-525-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 VIAL (52125-525-02)</PackageDescription>
<NDC11Code>52125-0525-02</NDC11Code>
<ProductNDC>52125-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Avelox</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021085</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>55111-525-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-525-30) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0525-30</NDC11Code>
<ProductNDC>55111-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
</NDCList>