{
"NDC": [
{
"NDCCode": "68462-480-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-480-56) / 125 mL in 1 BOTTLE",
"NDC11Code": "68462-0480-56",
"ProductNDC": "68462-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209004",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "68462-480-39",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLE",
"NDC11Code": "68462-0480-39",
"ProductNDC": "68462-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209004",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).",
"Description": "Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid."
},
{
"NDCCode": "68462-185-56",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68462-0185-56",
"ProductNDC": "68462-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20181218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211815",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181218",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.",
"Description": "Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF."
},
{
"NDCCode": "68462-659-84",
"PackageDescription": "12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "68462-0659-84",
"ProductNDC": "68462-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ryaltris",
"NonProprietaryName": "Olopatadine Hydrochloride And Mometasone Furoate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211746",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE",
"StrengthNumber": "665; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.",
"Description": "RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "68462-893-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (68462-893-56) ",
"NDC11Code": "68462-0893-56",
"ProductNDC": "68462-893",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214255",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc."
},
{
"NDCCode": "68462-894-04",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68462-0894-04",
"ProductNDC": "68462-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214255",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc."
},
{
"NDCCode": "68462-894-56",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56) ",
"NDC11Code": "68462-0894-56",
"ProductNDC": "68462-894",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214255",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230822",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc."
},
{
"NDCCode": "68462-386-14",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68462-386-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "68462-0386-14",
"ProductNDC": "68462-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-386-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68462-386-30) ",
"NDC11Code": "68462-0386-30",
"ProductNDC": "68462-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-386-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68462-386-90) ",
"NDC11Code": "68462-0386-90",
"ProductNDC": "68462-386",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-387-14",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "68462-0387-14",
"ProductNDC": "68462-387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-387-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30) ",
"NDC11Code": "68462-0387-30",
"ProductNDC": "68462-387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-387-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90) ",
"NDC11Code": "68462-0387-90",
"ProductNDC": "68462-387",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209239",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40."
},
{
"NDCCode": "68462-166-07",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "68462-0166-07",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-166-15",
"PackageDescription": "28 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "68462-0166-15",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-166-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68462-166-30) ",
"NDC11Code": "68462-0166-30",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-464-17",
"PackageDescription": "15 g in 1 CARTON (68462-464-17) ",
"NDC11Code": "68462-0464-17",
"ProductNDC": "68462-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202145",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum."
},
{
"NDCCode": "68462-464-47",
"PackageDescription": "45 g in 1 CARTON (68462-464-47) ",
"NDC11Code": "68462-0464-47",
"ProductNDC": "68462-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202145",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum."
},
{
"NDCCode": "68462-464-65",
"PackageDescription": "60 g in 1 CARTON (68462-464-65) ",
"NDC11Code": "68462-0464-65",
"ProductNDC": "68462-464",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202145",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20131205",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum."
},
{
"NDCCode": "21695-640-56",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (21695-640-56)",
"NDC11Code": "21695-0640-56",
"ProductNDC": "21695-640",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "52959-336-56",
"PackageDescription": "56 CAPSULE in 1 BOTTLE, PLASTIC (52959-336-56)",
"NDC11Code": "52959-0336-56",
"ProductNDC": "52959-336",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride, and has the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10, gelatin, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, and titanium dioxide. The 250 mg capsules also contain black iron oxide, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, and FD&C Yellow #6. The 500 mg capsules also contain ammonium hydroxide, FD&C Blue #1, FD&C Red #40, and simethicone."
},
{
"NDCCode": "70556-103-14",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (70556-103-14) > 4 PACKAGE in 1 BLISTER PACK > 1 KIT in 1 PACKAGE",
"NDC11Code": "70556-0103-14",
"ProductNDC": "70556-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride",
"NonProprietaryName": "Bismuth Subsalicylate Chewable Tablets/metronidazole Tablets/tetracycline Hydrochloride Capsules",
"DosageFormName": "KIT",
"StartMarketingDate": "20181130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202584",
"LabelerName": "Ailex Pharmaceuticals, LLC",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181130",
"SamplePackage": "N",
"IndicationAndUsage": "The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules consists of 112 bismuth subsalicylate 262.4-mg chewable tablets, 56 metronidazole 250-mg tablets, USP, and 56 tetracycline hydrochloride 500-mg capsules, USP, for oral administration. Bismuth subsalicylate chewable tablets: Each pink round tablet contains 262.4 mg bismuth subsalicylate (102 mg salicylate) for oral administration. Bismuth subsalicylate is a fine, white, odorless, and tasteless powder that is stable and non-hygroscopic. It is a highly insoluble salt of trivalent bismuth and salicylic acid. Bismuth subsalicylate is 2-Hydroxybenzoic acid bismuth (3+) salt with the following structural formula. Molecular weight: 362.11. Inactive Ingredients: Each bismuth subsalicylate chewable tablet contains calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, talc, and wintergreen flavor. Metronidazole tablets, USP: Each round, white tablet contains 250 mg metronidazole. Metronidazole is 2Methyl-5-nitroimidazole-1-ethanol, with the following structural formula. Molecular weight: 171.16. Inactive Ingredients: Each metronidazole tablet contains colloidal silicon dioxide, hydroxypropyl cellulose, lactose (anhydrous), sodium starch glycolate, stearic acid, and microcrystalline cellulose. Tetracycline hydrochloride capsules, USP: Each black and yellow capsule contains 500 mg tetracycline hydrochloride. Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and ether. Tetracycline hydrochloride is (4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, with the following structural formula. Molecular weight: 480.90. Inactive Ingredients: Each tetracycline hydrochloride capsule contains lactose, magnesium stearate and sodium lauryl sulfate; D & C yellow no.10, FD & C blue No 1, FD & C red no. 40, gelatin and titanium dioxide. It may also contain benzyl alcohol, butylparaben, edetate calcium disodium, FD & C yellow no. 6, methylparaben, propylparaben, silicon dioxide and sodium propionate. The imprinting ink for tetracycline hydrochloride capsule contains titanium dioxide. It may also contain dimethyl polysiloxane, distilled water, ethyl alcohol, ethylene glycol monoethyl ether, pharmaceutical glaze, pharmaceutical shellac, and soya lecithin."
},
{
"NDCCode": "68462-101-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-101-10) ",
"NDC11Code": "68462-0101-10",
"ProductNDC": "68462-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060125",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-101-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (68462-101-30) ",
"NDC11Code": "68462-0101-30",
"ProductNDC": "68462-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20060125",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-102-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-102-10) ",
"NDC11Code": "68462-0102-10",
"ProductNDC": "68462-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060125",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-102-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (68462-102-30) ",
"NDC11Code": "68462-0102-30",
"ProductNDC": "68462-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060125",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-103-40",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (68462-103-40) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "68462-0103-40",
"ProductNDC": "68462-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "68462-104-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-104-10) ",
"NDC11Code": "68462-0104-10",
"ProductNDC": "68462-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20060125",
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"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-104-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (68462-104-30) ",
"NDC11Code": "68462-0104-30",
"ProductNDC": "68462-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077253",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060125",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30."
},
{
"NDCCode": "68462-105-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68462-105-30) ",
"NDC11Code": "68462-0105-30",
"ProductNDC": "68462-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077535",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070625",
"SamplePackage": "N"
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]
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<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>68462-480-39</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-480-39) / 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0480-39</NDC11Code>
<ProductNDC>68462-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209004</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1). Limitations of Use: 1 Do not use on the face, axillae or groin. (1.2), 2 Do not use if atrophy is present at the treatment site. (1.2), 3 Do not use for rosacea or perioral dermatitis. (1.2).</IndicationAndUsage>
<Description>Clobetasol Propionate Spray, 0.05% contains clobetasol propionate USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97 g/mol (CAS Registry Number 25122-46-7). The following is the chemical structure. Clobetasol propionate, USP. Clobetasol propionate, USP is a white to almost white, crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.</Description>
</NDC>
<NDC>
<NDCCode>68462-185-56</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68462-0185-56</NDC11Code>
<ProductNDC>68462-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20181218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211815</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.</Description>
</NDC>
<NDC>
<NDCCode>68462-659-84</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (68462-659-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68462-0659-84</NDC11Code>
<ProductNDC>68462-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ryaltris</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride And Mometasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211746</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
<StrengthNumber>665; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.</IndicationAndUsage>
<Description>RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, glycerin, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>68462-893-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (68462-893-56) </PackageDescription>
<NDC11Code>68462-0893-56</NDC11Code>
<ProductNDC>68462-893</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214255</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
</NDC>
<NDC>
<NDCCode>68462-894-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68462-894-04) / 56 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0894-04</NDC11Code>
<ProductNDC>68462-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214255</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
</NDC>
<NDC>
<NDCCode>68462-894-56</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (68462-894-56) </PackageDescription>
<NDC11Code>68462-0894-56</NDC11Code>
<ProductNDC>68462-894</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214255</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is white to off white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg white to off-white, modified capsule shaped, film-coated tablets debossed with 'L' on one side and '11' on other side and a 1 mg light pink to pink color, modified capsule shaped, film coated tablets debossed with 'L' on one side and '12' on other side. Each 0.5 mg varenicline tablets contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablets contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: anhydrous dibasic calcium phosphate, butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose. The tablet film coating contains hydroxypropyl cellulose, hypromellose, and titanium dioxide. In addition to these, the 1 mg tablet film coating also includes D&C Red #27/phloxine aluminum lake, D&C yellow #10 aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake and talc.</Description>
</NDC>
<NDC>
<NDCCode>68462-386-14</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68462-386-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0386-14</NDC11Code>
<ProductNDC>68462-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-386-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68462-386-30) </PackageDescription>
<NDC11Code>68462-0386-30</NDC11Code>
<ProductNDC>68462-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-386-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68462-386-90) </PackageDescription>
<NDC11Code>68462-0386-90</NDC11Code>
<ProductNDC>68462-386</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-387-14</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0387-14</NDC11Code>
<ProductNDC>68462-387</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-387-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30) </PackageDescription>
<NDC11Code>68462-0387-30</NDC11Code>
<ProductNDC>68462-387</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-387-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90) </PackageDescription>
<NDC11Code>68462-0387-90</NDC11Code>
<ProductNDC>68462-387</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209239</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with 1(S)-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylic acid 3(R)-quinuclidinyl ester Monosuccinate having an empirical formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55 g/mol. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble or soluble in water, glacial acetic acid, dimethyl sulfoxide; soluble in methanol, very slightly soluble in acetone and ethanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, the tablets also contain the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin. The 5 mg tablets contain the colorants iron oxide yellow and FD&C yellow# 6. The 10 mg tablets contain the colorants iron oxide yellow and FD&C Red# 40.</Description>
</NDC>
<NDC>
<NDCCode>68462-166-07</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0166-07</NDC11Code>
<ProductNDC>68462-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207985</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-166-15</NDCCode>
<PackageDescription>28 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0166-15</NDC11Code>
<ProductNDC>68462-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207985</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-166-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68462-166-30) </PackageDescription>
<NDC11Code>68462-0166-30</NDC11Code>
<ProductNDC>68462-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207985</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>68462-464-17</NDCCode>
<PackageDescription>15 g in 1 CARTON (68462-464-17) </PackageDescription>
<NDC11Code>68462-0464-17</NDC11Code>
<ProductNDC>68462-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202145</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-464-47</NDCCode>
<PackageDescription>45 g in 1 CARTON (68462-464-47) </PackageDescription>
<NDC11Code>68462-0464-47</NDC11Code>
<ProductNDC>68462-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202145</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>68462-464-65</NDCCode>
<PackageDescription>60 g in 1 CARTON (68462-464-65) </PackageDescription>
<NDC11Code>68462-0464-65</NDC11Code>
<ProductNDC>68462-464</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202145</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: : 1 Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. , 2 The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula. Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C25H36O6. It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>21695-640-56</NDCCode>
<PackageDescription>56 CAPSULE in 1 BOTTLE (21695-640-56)</PackageDescription>
<NDC11Code>21695-0640-56</NDC11Code>
<ProductNDC>21695-640</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-336-56</NDCCode>
<PackageDescription>56 CAPSULE in 1 BOTTLE, PLASTIC (52959-336-56)</PackageDescription>
<NDC11Code>52959-0336-56</NDC11Code>
<ProductNDC>52959-336</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride, and has the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10, gelatin, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, and titanium dioxide. The 250 mg capsules also contain black iron oxide, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, and FD&C Yellow #6. The 500 mg capsules also contain ammonium hydroxide, FD&C Blue #1, FD&C Red #40, and simethicone.</Description>
</NDC>
<NDC>
<NDCCode>70556-103-14</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (70556-103-14) > 4 PACKAGE in 1 BLISTER PACK > 1 KIT in 1 PACKAGE</PackageDescription>
<NDC11Code>70556-0103-14</NDC11Code>
<ProductNDC>70556-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate Chewable Tablets/metronidazole Tablets/tetracycline Hydrochloride Capsules</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202584</ApplicationNumber>
<LabelerName>Ailex Pharmaceuticals, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules consists of 112 bismuth subsalicylate 262.4-mg chewable tablets, 56 metronidazole 250-mg tablets, USP, and 56 tetracycline hydrochloride 500-mg capsules, USP, for oral administration. Bismuth subsalicylate chewable tablets: Each pink round tablet contains 262.4 mg bismuth subsalicylate (102 mg salicylate) for oral administration. Bismuth subsalicylate is a fine, white, odorless, and tasteless powder that is stable and non-hygroscopic. It is a highly insoluble salt of trivalent bismuth and salicylic acid. Bismuth subsalicylate is 2-Hydroxybenzoic acid bismuth (3+) salt with the following structural formula. Molecular weight: 362.11. Inactive Ingredients: Each bismuth subsalicylate chewable tablet contains calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, povidone, saccharin sodium, talc, and wintergreen flavor. Metronidazole tablets, USP: Each round, white tablet contains 250 mg metronidazole. Metronidazole is 2Methyl-5-nitroimidazole-1-ethanol, with the following structural formula. Molecular weight: 171.16. Inactive Ingredients: Each metronidazole tablet contains colloidal silicon dioxide, hydroxypropyl cellulose, lactose (anhydrous), sodium starch glycolate, stearic acid, and microcrystalline cellulose. Tetracycline hydrochloride capsules, USP: Each black and yellow capsule contains 500 mg tetracycline hydrochloride. Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and ether. Tetracycline hydrochloride is (4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, with the following structural formula. Molecular weight: 480.90. Inactive Ingredients: Each tetracycline hydrochloride capsule contains lactose, magnesium stearate and sodium lauryl sulfate; D & C yellow no.10, FD & C blue No 1, FD & C red no. 40, gelatin and titanium dioxide. It may also contain benzyl alcohol, butylparaben, edetate calcium disodium, FD & C yellow no. 6, methylparaben, propylparaben, silicon dioxide and sodium propionate. The imprinting ink for tetracycline hydrochloride capsule contains titanium dioxide. It may also contain dimethyl polysiloxane, distilled water, ethyl alcohol, ethylene glycol monoethyl ether, pharmaceutical glaze, pharmaceutical shellac, and soya lecithin.</Description>
</NDC>
<NDC>
<NDCCode>68462-101-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-101-10) </PackageDescription>
<NDC11Code>68462-0101-10</NDC11Code>
<ProductNDC>68462-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
</NDC>
<NDC>
<NDCCode>68462-101-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68462-101-30) </PackageDescription>
<NDC11Code>68462-0101-30</NDC11Code>
<ProductNDC>68462-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
</NDC>
<NDC>
<NDCCode>68462-102-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-102-10) </PackageDescription>
<NDC11Code>68462-0102-10</NDC11Code>
<ProductNDC>68462-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
</NDC>
<NDC>
<NDCCode>68462-102-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68462-102-30) </PackageDescription>
<NDC11Code>68462-0102-30</NDC11Code>
<ProductNDC>68462-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
</NDC>
<NDC>
<NDCCode>68462-103-40</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (68462-103-40) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68462-0103-40</NDC11Code>
<ProductNDC>68462-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-104-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-104-10) </PackageDescription>
<NDC11Code>68462-0104-10</NDC11Code>
<ProductNDC>68462-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077253</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
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<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: : 1 1.Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 3 3.Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1’,1’-bis(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.27. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30.</Description>
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