{
"NDC": [
{
"NDCCode": "73190-067-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-067-30) ",
"NDC11Code": "73190-0067-30",
"ProductNDC": "73190-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091482",
"LabelerName": "AvKARE",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251204",
"SamplePackage": "N",
"IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in: : 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1, 14.3). , 3 One maintenance study with IR fluvoxamine tablets ( 14.2). .",
"Description": "Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate USP, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula C 15H 21O 2N 2F 3C 4H 4O 4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C Blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "73190-004-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-004-30) ",
"NDC11Code": "73190-0004-30",
"ProductNDC": "73190-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil Hydrochlorides Extended-release",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208328",
"LabelerName": "AvKARE",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "28; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride, USP. The chemical name for memantine hydrochloride, USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N HCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder. Donepezil Hydrochloride, USP. The chemical name for donepezil hydrochloride, USP is (±)-2-[(1-benzyl- 4-piperidyl) methyl]-5,6-dimethoxy-1-indanone hydrochloride. The molecular formula is C 24H 29NO 3HCl and the molecular weight is 415.95. Donepezil hydrochloride, USP is off white to cream coloured powder. Memantine and donepezil hydrochlorides extended-release capsules contain 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). Memantine and donepezil hydrochlorides extended-release capsules (14 mg/10 mg)contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, sodium hydroxide, propylene glycol, povidone, shellac and titanium dioxide. Memantine and donepezil hydrochlorides extended-release capsules (28 mg/10 mg)contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "73190-035-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-035-30) ",
"NDC11Code": "73190-0035-30",
"ProductNDC": "73190-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "AvKARE",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the molecular formula C 17H 18N 4OHCl, representing a molecular weight of 330.81 g/mol. Alosetron is a white to pale brown color powder that has a solubility of 70.5 mg/mL in DI Water, 45.7 mg/mL in 0.1 N HCl, 79.4 mg/mL in pH 4.5 Acetate Buffer, 3.2 mg/mL in pH 6.8 Phosphate Buffer and 0.1 mg/mL in pH 7.5 Phosphate Buffer. The chemical structure of alosetron is:. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "73190-036-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-036-30) ",
"NDC11Code": "73190-0036-30",
"ProductNDC": "73190-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alosetron Hydrochloride",
"NonProprietaryName": "Alosetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206647",
"LabelerName": "AvKARE",
"SubstanceName": "ALOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.",
"Description": "The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the molecular formula C 17H 18N 4OHCl, representing a molecular weight of 330.81 g/mol. Alosetron is a white to pale brown color powder that has a solubility of 70.5 mg/mL in DI Water, 45.7 mg/mL in 0.1 N HCl, 79.4 mg/mL in pH 4.5 Acetate Buffer, 3.2 mg/mL in pH 6.8 Phosphate Buffer and 0.1 mg/mL in pH 7.5 Phosphate Buffer. The chemical structure of alosetron is:. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "73190-038-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-038-30) ",
"NDC11Code": "73190-0038-30",
"ProductNDC": "73190-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride",
"NonProprietaryName": "Prucalopride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218977",
"LabelerName": "AvKARE",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18H 26ClN 3O 3.C 4H 6O 4 and the molecular weight is 485.96. The structural formula is:. Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N-dimethylformamide, N,N-dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "73190-039-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-039-30) ",
"NDC11Code": "73190-0039-30",
"ProductNDC": "73190-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prucalopride",
"NonProprietaryName": "Prucalopride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218977",
"LabelerName": "AvKARE",
"SubstanceName": "PRUCALOPRIDE SUCCINATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250725",
"SamplePackage": "N",
"IndicationAndUsage": "Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.",
"Description": "Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18H 26ClN 3O 3.C 4H 6O 4 and the molecular weight is 485.96. The structural formula is:. Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N-dimethylformamide, N,N-dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "73190-040-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (73190-040-30) ",
"NDC11Code": "73190-0040-30",
"ProductNDC": "73190-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217170",
"LabelerName": "AvKARE",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250902",
"SamplePackage": "N",
"Description": "Doxycycline capsules 40 mg are hard gelatin capsule shells filled with 33.25 mg immediate release and 6.75 mg delayed release minitablets that together provide a dose of 40 mg of doxycycline. The structural formula of doxycycline, USP is. with a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.45; 444.43 (anhydrous). The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate (USP). It is very slightly soluble in water. Doxycycline capsules are supplied in 40 mg strength for oral administration containing doxycycline as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer (1:2), microcrystalline cellulose, talc, and triethyl citrate. FDA approved dissolution test method and specifications differ from USP."
},
{
"NDCCode": "73190-049-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-049-30) ",
"NDC11Code": "73190-0049-30",
"ProductNDC": "73190-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "AvKARE",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "73190-050-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-050-30) ",
"NDC11Code": "73190-0050-30",
"ProductNDC": "73190-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "AvKARE",
"SubstanceName": "DASATINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "73190-051-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-051-30) ",
"NDC11Code": "73190-0051-30",
"ProductNDC": "73190-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211094",
"LabelerName": "AvKARE",
"SubstanceName": "DASATINIB",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251118",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin."
},
{
"NDCCode": "73190-052-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (73190-052-30) ",
"NDC11Code": "73190-0052-30",
"ProductNDC": "73190-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deferasirox",
"NonProprietaryName": "Deferasirox",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210945",
"LabelerName": "AvKARE",
"SubstanceName": "DEFERASIROX",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260114",
"SamplePackage": "N",
"IndicationAndUsage": "Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1) Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.( 1.2) Limitations of Use The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. ( 1.3).",
"Description": "Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxy-phenyl)-1 H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula:. Deferasirox is a white to slightly yellow colour powder. It has a molecular formula C 21H 15N 3O 4and molecular weight of 373.36. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, low substituted hydroxy propyl cellulose, microcrystalline cellulose, poloxamer (188), povidone (K30) and sodium stearyl fumarate. The film coating contains .hypromellose, titanium dioxide, propylene glycol, talc and iron oxide yellow."
},
{
"NDCCode": "73190-066-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-066-30) ",
"NDC11Code": "73190-0066-30",
"ProductNDC": "73190-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluvoxamine Maleate",
"NonProprietaryName": "Fluvoxamine Maleate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091482",
"LabelerName": "AvKARE",
"SubstanceName": "FLUVOXAMINE MALEATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251204",
"SamplePackage": "N",
"IndicationAndUsage": "Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in: : 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1, 14.3). , 3 One maintenance study with IR fluvoxamine tablets ( 14.2). .",
"Description": "Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate USP, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula C 15H 21O 2N 2F 3C 4H 4O 4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C Blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "73190-069-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (73190-069-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "73190-0069-30",
"ProductNDC": "73190-069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219254",
"LabelerName": "AvKARE",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "73190-070-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (73190-070-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "73190-0070-30",
"ProductNDC": "73190-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219254",
"LabelerName": "AvKARE",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "73190-071-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (73190-071-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "73190-0071-30",
"ProductNDC": "73190-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219254",
"LabelerName": "AvKARE",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "36",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251210",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "73190-072-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-072-30) ",
"NDC11Code": "73190-0072-30",
"ProductNDC": "73190-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211478",
"LabelerName": "AvKARE",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260525",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21H 25ClO 6and the molecular weight is 408.88. The structural formula is:. Dapagliflozin tablets is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow."
},
{
"NDCCode": "73190-073-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-073-30) ",
"NDC11Code": "73190-0073-30",
"ProductNDC": "73190-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211478",
"LabelerName": "AvKARE",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260525",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21H 25ClO 6and the molecular weight is 408.88. The structural formula is:. Dapagliflozin tablets is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow."
},
{
"NDCCode": "73190-087-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (73190-087-30) ",
"NDC11Code": "73190-0087-30",
"ProductNDC": "73190-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Roflumilast",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208247",
"LabelerName": "AvKARE",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260624",
"SamplePackage": "N",
"IndicationAndUsage": "Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use. Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.",
"Description": "The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridine-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide or. Its molecular formula is C 17H 14Cl 2F 2N 2O 3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic granular powder with a melting point of 160°C. It is practically insoluble in water and hexane; sparingly soluble in ethanol and methanol; and soluble in N,N-Dimethyl formamide. Roflumilast 250 mcg are supplied as white to off-white, round tablets, debossed with \"4\" on one side, \"C\" on the other side. Roflumilast 500 mcg tablets are supplied as white to off-white, round tablets, debossed with \"0.5\" on one side, \"R\" on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each roflumilast tablet for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose and magnesium stearate."
},
{
"NDCCode": "73190-091-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-091-30) ",
"NDC11Code": "73190-0091-30",
"ProductNDC": "73190-091",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202438",
"LabelerName": "AvKARE",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260721",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "73190-092-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-092-30) ",
"NDC11Code": "73190-0092-30",
"ProductNDC": "73190-092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202438",
"LabelerName": "AvKARE",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260721",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "73190-093-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (73190-093-30) ",
"NDC11Code": "73190-0093-30",
"ProductNDC": "73190-093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202438",
"LabelerName": "AvKARE",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260721",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide."
},
{
"NDCCode": "73190-102-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73190-102-30) ",
"NDC11Code": "73190-0102-30",
"ProductNDC": "73190-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tofacitinib",
"NonProprietaryName": "Tofacitinib",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220458",
"LabelerName": "AvKARE",
"SubstanceName": "TOFACITINIB CITRATE",
"StrengthNumber": "11",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260624",
"SamplePackage": "N",
"IndicationAndUsage": "Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA),who have had an inadequate response or intolerance to one or more TNF blockers. , 2 Active psoriatic arthritis (PsA),who have had an inadequate response or intolerance to one or more TNF blockers. , 3 Active ankylosing spondylitis (AS),who have had an inadequate response or intolerance to one or more TNF blockers. .",
"Description": "Tofacitinib extended-release tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo [2,3- d]pyrimidin-4-ylamino)-β-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.49 g/mol (or 312.37 g/mol as the tofacitinib free base) and a molecular formula of C 16H 20N 6OC 6H 8O 7. The chemical structure of tofacitinib citrate is:. Tofacitinib extended-release tablets are supplied for oral administration as a: 1 11 mg white to off-white, oval shape, biconvex film-coated tablet. Engraved “T1” on one side, plain on the other side. Each 11 mg tablet of tofacitinib extended-release tablet contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxypropyl methylcellulose 2208, hydroxypropyl methylcellulose 2910, MAA (methacrylic acid) and ETAC (ethyl acrylate) copolymer, magnesium stearate, mannitol, and talc."
},
{
"NDCCode": "10702-067-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (10702-067-03) ",
"NDC11Code": "10702-0067-03",
"ProductNDC": "10702-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203436",
"LabelerName": "KVK-TECH, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2018-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180329",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine (see Clinical Pharmacology), should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride tablet, USP is available as an oral tablet containing 8 mg of phentermine hydrochloride (equivalent to 6.4 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: Corn Starch, Magnesium Stearate, NF, Microcrystalline Cellulose 102, NF, Stearic Acid, NF, FD&C Blue #1."
},
{
"NDCCode": "13668-067-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-067-30) ",
"NDC11Code": "13668-0067-30",
"ProductNDC": "13668-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202728",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N"
},
{
"NDCCode": "14783-067-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-067-02) > 30 g in 1 TUBE (14783-067-01)",
"NDC11Code": "14783-0067-02",
"ProductNDC": "14783-067",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Instant Perfection 3 En 1 Face Refining Foundation Spf 25",
"ProprietaryNameSuffix": "Medio 2 - Beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161216",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".065; .036",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "17156-067-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "17156-0067-30",
"ProductNDC": "17156-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vizamyl",
"NonProprietaryName": "Flutemetamol F-18",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203137",
"LabelerName": "GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)",
"SubstanceName": "FLUTEMETAMOL F-18",
"StrengthNumber": "4.05",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140301",
"SamplePackage": "N",
"IndicationAndUsage": "VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline, 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.",
"Description": "VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C14H1118FN2OS, the molecular weight 273.32, and the following structural formula. VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution. Each mL contains up to 2 mcg of flutemetamol and 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time with the following inactive ingredients: 70 microL ethanol, 9 mg sodium chloride, and 4.98 mg polysorbate 80 (w/v) in 0.014 M aqueous phosphate buffer. The pH of the solution is between 6 and 8.5."
},
{
"NDCCode": "21695-067-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-067-30)",
"NDC11Code": "21695-0067-30",
"ProductNDC": "21695-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: microcrystalline cellulose, copovidone (plasdone-S630), sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white (OY-LS-58900), polysorbate 80."
},
{
"NDCCode": "24385-067-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (24385-067-10) / 30 mL in 1 BOTTLE",
"NDC11Code": "24385-0067-10",
"ProductNDC": "24385-067",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Nasal",
"ProprietaryNameSuffix": "Extra Moisturizing",
"NonProprietaryName": "Oxymetazoline Hcl",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19950504",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19950504",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves nasal congestion due to:. common cold . hay fever . upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely."
},
{
"NDCCode": "24724-067-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (24724-067-03)",
"NDC11Code": "24724-0067-03",
"ProductNDC": "24724-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207433",
"LabelerName": "INDICUS PHARMA LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Desipramine hydrochloride tablets, USP is indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5 H - Dibenz [bƒ] azepine - 5 - propanamine, 10, 11 - dihydro - N - methyl -, monohydrochloride. Inactive IngredientsThe following inactive ingredients are contained in all dosage strengths: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A (potato), stearic acid and hypromellose, talc, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "27241-067-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (27241-067-03) ",
"NDC11Code": "27241-0067-03",
"ProductNDC": "27241-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206401",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181012",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil citrate is indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as green, oval-shaped, beveled edge, biconvex, film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, FD & C Blue #1/brilliant blue FCF aluminum lake, D & C yellow # 10 aluminum lake. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>73190-067-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-067-30) </PackageDescription>
<NDC11Code>73190-0067-30</NDC11Code>
<ProductNDC>73190-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091482</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in: : 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1, 14.3). , 3 One maintenance study with IR fluvoxamine tablets ( 14.2). .</IndicationAndUsage>
<Description>Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate USP, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula C 15H 21O 2N 2F 3C 4H 4O 4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C Blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>73190-004-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-004-30) </PackageDescription>
<NDC11Code>73190-0004-30</NDC11Code>
<ProductNDC>73190-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil Hydrochlorides Extended-release</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208328</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride, USP. The chemical name for memantine hydrochloride, USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C 12H 21N HCl and the molecular weight is 215.76. Memantine hydrochloride, USP occurs as a fine white to off-white powder. Donepezil Hydrochloride, USP. The chemical name for donepezil hydrochloride, USP is (±)-2-[(1-benzyl- 4-piperidyl) methyl]-5,6-dimethoxy-1-indanone hydrochloride. The molecular formula is C 24H 29NO 3HCl and the molecular weight is 415.95. Donepezil hydrochloride, USP is off white to cream coloured powder. Memantine and donepezil hydrochlorides extended-release capsules contain 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). Memantine and donepezil hydrochlorides extended-release capsules (14 mg/10 mg)contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, sodium hydroxide, propylene glycol, povidone, shellac and titanium dioxide. Memantine and donepezil hydrochlorides extended-release capsules (28 mg/10 mg)contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>73190-035-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-035-30) </PackageDescription>
<NDC11Code>73190-0035-30</NDC11Code>
<ProductNDC>73190-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the molecular formula C 17H 18N 4OHCl, representing a molecular weight of 330.81 g/mol. Alosetron is a white to pale brown color powder that has a solubility of 70.5 mg/mL in DI Water, 45.7 mg/mL in 0.1 N HCl, 79.4 mg/mL in pH 4.5 Acetate Buffer, 3.2 mg/mL in pH 6.8 Phosphate Buffer and 0.1 mg/mL in pH 7.5 Phosphate Buffer. The chemical structure of alosetron is:. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-036-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-036-30) </PackageDescription>
<NDC11Code>73190-0036-30</NDC11Code>
<ProductNDC>73190-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alosetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Alosetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206647</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ALOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: 1 chronic IBS symptoms (generally lasting 6 months or longer),, 2 had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and, 3 not responded adequately to conventional therapy.</IndicationAndUsage>
<Description>The active ingredient in alosetron tablets, USP is alosetron hydrochloride (HCl) USP, a potent and selective antagonist of the serotonin 5-HT 3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the molecular formula C 17H 18N 4OHCl, representing a molecular weight of 330.81 g/mol. Alosetron is a white to pale brown color powder that has a solubility of 70.5 mg/mL in DI Water, 45.7 mg/mL in 0.1 N HCl, 79.4 mg/mL in pH 4.5 Acetate Buffer, 3.2 mg/mL in pH 6.8 Phosphate Buffer and 0.1 mg/mL in pH 7.5 Phosphate Buffer. The chemical structure of alosetron is:. Alosetron tablets, USP are supplied for oral administration as 0.5 mg (white) and 1 mg (light blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron and the 1 mg tablet contains 1.124 mg alosetron hydrochloride, USP equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). The white film coat for the 0.5 mg tablet contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. The light blue film coat for the 1 mg tablet contains FD&C blue #2, hypromellose, macrogol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-038-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-038-30) </PackageDescription>
<NDC11Code>73190-0038-30</NDC11Code>
<ProductNDC>73190-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride</ProprietaryName>
<NonProprietaryName>Prucalopride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218977</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18H 26ClN 3O 3.C 4H 6O 4 and the molecular weight is 485.96. The structural formula is:. Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N-dimethylformamide, N,N-dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>73190-039-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-039-30) </PackageDescription>
<NDC11Code>73190-0039-30</NDC11Code>
<ProductNDC>73190-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prucalopride</ProprietaryName>
<NonProprietaryName>Prucalopride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218977</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PRUCALOPRIDE SUCCINATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.</IndicationAndUsage>
<Description>Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18H 26ClN 3O 3.C 4H 6O 4 and the molecular weight is 485.96. The structural formula is:. Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N-dimethylformamide, N,N-dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>73190-040-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (73190-040-30) </PackageDescription>
<NDC11Code>73190-0040-30</NDC11Code>
<ProductNDC>73190-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217170</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Doxycycline capsules 40 mg are hard gelatin capsule shells filled with 33.25 mg immediate release and 6.75 mg delayed release minitablets that together provide a dose of 40 mg of doxycycline. The structural formula of doxycycline, USP is. with a molecular formula of C 22H 24N 2O 8H 2O and a molecular weight of 462.45; 444.43 (anhydrous). The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate (USP). It is very slightly soluble in water. Doxycycline capsules are supplied in 40 mg strength for oral administration containing doxycycline as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer (1:2), microcrystalline cellulose, talc, and triethyl citrate. FDA approved dissolution test method and specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>73190-049-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-049-30) </PackageDescription>
<NDC11Code>73190-0049-30</NDC11Code>
<ProductNDC>73190-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211094</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>73190-050-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-050-30) </PackageDescription>
<NDC11Code>73190-0050-30</NDC11Code>
<ProductNDC>73190-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211094</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>73190-051-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-051-30) </PackageDescription>
<NDC11Code>73190-0051-30</NDC11Code>
<ProductNDC>73190-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211094</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)- 2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22H 26ClN 7O 2S H 2O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:. Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>73190-052-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (73190-052-30) </PackageDescription>
<NDC11Code>73190-0052-30</NDC11Code>
<ProductNDC>73190-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deferasirox</ProprietaryName>
<NonProprietaryName>Deferasirox</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210945</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFERASIROX</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1) Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.( 1.2) Limitations of Use The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. ( 1.3).</IndicationAndUsage>
<Description>Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxy-phenyl)-1 H-1,2,4-triazol-1-yl] benzoic acid and has the following structural formula:. Deferasirox is a white to slightly yellow colour powder. It has a molecular formula C 21H 15N 3O 4and molecular weight of 373.36. Deferasirox tablets contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, lactose monohydrate, low substituted hydroxy propyl cellulose, microcrystalline cellulose, poloxamer (188), povidone (K30) and sodium stearyl fumarate. The film coating contains .hypromellose, titanium dioxide, propylene glycol, talc and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>73190-066-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-066-30) </PackageDescription>
<NDC11Code>73190-0066-30</NDC11Code>
<ProductNDC>73190-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluvoxamine Maleate</ProprietaryName>
<NonProprietaryName>Fluvoxamine Maleate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091482</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FLUVOXAMINE MALEATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1). Efficacy was demonstrated in: : 1 One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1). , 2 Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1, 14.3). , 3 One maintenance study with IR fluvoxamine tablets ( 14.2). .</IndicationAndUsage>
<Description>Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate USP, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the molecular formula C 15H 21O 2N 2F 3C 4H 4O 4. Its molecular weight is 434.41. The structural formula is. Fluvoxamine maleate, USP is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer, type A, ammonio methacrylate copolymer, type B, black iron oxide, FD&C Blue #1, gelatin, hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide. The capsules are imprinted with black Tek-Print ink SW-9008 and SW-9009 which contain black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>73190-069-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (73190-069-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>73190-0069-30</NDC11Code>
<ProductNDC>73190-069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219254</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>73190-070-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (73190-070-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>73190-0070-30</NDC11Code>
<ProductNDC>73190-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219254</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>73190-071-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (73190-071-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>73190-0071-30</NDC11Code>
<ProductNDC>73190-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219254</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>36</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'sEmflaza(deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>73190-072-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-072-30) </PackageDescription>
<NDC11Code>73190-0072-30</NDC11Code>
<ProductNDC>73190-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211478</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21H 25ClO 6and the molecular weight is 408.88. The structural formula is:. Dapagliflozin tablets is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>73190-073-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-073-30) </PackageDescription>
<NDC11Code>73190-0073-30</NDC11Code>
<ProductNDC>73190-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211478</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin tablet is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Dapagliflozin, an inhibitor of SGL T2, is described chemically as (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21H 25ClO 6and the molecular weight is 408.88. The structural formula is:. Dapagliflozin tablets is available as a film-coated tablet for oral administration containing the 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: crospovidone, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, sodium lauryl sulphate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>73190-087-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (73190-087-30) </PackageDescription>
<NDC11Code>73190-0087-30</NDC11Code>
<ProductNDC>73190-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Roflumilast</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208247</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Roflumilast tablets are indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use. Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.</IndicationAndUsage>
<Description>The active ingredient in roflumilast tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridine-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide or. Its molecular formula is C 17H 14Cl 2F 2N 2O 3 and the molecular weight is 403.22. The chemical structure is. The drug substance is a white to off-white non-hygroscopic granular powder with a melting point of 160°C. It is practically insoluble in water and hexane; sparingly soluble in ethanol and methanol; and soluble in N,N-Dimethyl formamide. Roflumilast 250 mcg are supplied as white to off-white, round tablets, debossed with "4" on one side, "C" on the other side. Roflumilast 500 mcg tablets are supplied as white to off-white, round tablets, debossed with "0.5" on one side, "R" on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each roflumilast tablet for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>73190-091-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-091-30) </PackageDescription>
<NDC11Code>73190-0091-30</NDC11Code>
<ProductNDC>73190-091</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202438</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-092-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-092-30) </PackageDescription>
<NDC11Code>73190-0092-30</NDC11Code>
<ProductNDC>73190-092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202438</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-093-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (73190-093-30) </PackageDescription>
<NDC11Code>73190-0093-30</NDC11Code>
<ProductNDC>73190-093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202438</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients( 1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients( 1.2) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H-purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14H 19N 5O 4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>73190-102-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73190-102-30) </PackageDescription>
<NDC11Code>73190-0102-30</NDC11Code>
<ProductNDC>73190-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tofacitinib</ProprietaryName>
<NonProprietaryName>Tofacitinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220458</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TOFACITINIB CITRATE</SubstanceName>
<StrengthNumber>11</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitors. Tofacitinib extended-release tablets are indicated for the treatment of adult patients with: 1 Moderately to severely active rheumatoid arthritis (RA),who have had an inadequate response or intolerance to one or more TNF blockers. , 2 Active psoriatic arthritis (PsA),who have had an inadequate response or intolerance to one or more TNF blockers. , 3 Active ankylosing spondylitis (AS),who have had an inadequate response or intolerance to one or more TNF blockers. .</IndicationAndUsage>
<Description>Tofacitinib extended-release tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo [2,3- d]pyrimidin-4-ylamino)-β-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.49 g/mol (or 312.37 g/mol as the tofacitinib free base) and a molecular formula of C 16H 20N 6OC 6H 8O 7. The chemical structure of tofacitinib citrate is:. Tofacitinib extended-release tablets are supplied for oral administration as a: 1 11 mg white to off-white, oval shape, biconvex film-coated tablet. Engraved “T1” on one side, plain on the other side. Each 11 mg tablet of tofacitinib extended-release tablet contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxypropyl methylcellulose 2208, hydroxypropyl methylcellulose 2910, MAA (methacrylic acid) and ETAC (ethyl acrylate) copolymer, magnesium stearate, mannitol, and talc.</Description>
</NDC>
<NDC>
<NDCCode>10702-067-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10702-067-03) </PackageDescription>
<NDC11Code>10702-0067-03</NDC11Code>
<ProductNDC>10702-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203436</ApplicationNumber>
<LabelerName>KVK-TECH, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including phentermine (see Clinical Pharmacology), should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride tablet, USP is available as an oral tablet containing 8 mg of phentermine hydrochloride (equivalent to 6.4 mg of phentermine base). Each phentermine hydrochloride tablet also contains the following inactive ingredients: Corn Starch, Magnesium Stearate, NF, Microcrystalline Cellulose 102, NF, Stearic Acid, NF, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>13668-067-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-067-30) </PackageDescription>
<NDC11Code>13668-0067-30</NDC11Code>
<ProductNDC>13668-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202728</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14783-067-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-067-02) > 30 g in 1 TUBE (14783-067-01)</PackageDescription>
<NDC11Code>14783-0067-02</NDC11Code>
<ProductNDC>14783-067</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Instant Perfection 3 En 1 Face Refining Foundation Spf 25</ProprietaryName>
<ProprietaryNameSuffix>Medio 2 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161216</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .036</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17156-067-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>17156-0067-30</NDC11Code>
<ProductNDC>17156-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vizamyl</ProprietaryName>
<NonProprietaryName>Flutemetamol F-18</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203137</ApplicationNumber>
<LabelerName>GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)</LabelerName>
<SubstanceName>FLUTEMETAMOL F-18</SubstanceName>
<StrengthNumber>4.05</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: 1 Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline, 2 Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.</IndicationAndUsage>
<Description>VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C14H1118FN2OS, the molecular weight 273.32, and the following structural formula. VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution. Each mL contains up to 2 mcg of flutemetamol and 150 MBq (4.05 mCi) of flutemetamol F 18 at reference date and time with the following inactive ingredients: 70 microL ethanol, 9 mg sodium chloride, and 4.98 mg polysorbate 80 (w/v) in 0.014 M aqueous phosphate buffer. The pH of the solution is between 6 and 8.5.</Description>
</NDC>
<NDC>
<NDCCode>21695-067-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-067-30)</PackageDescription>
<NDC11Code>21695-0067-30</NDC11Code>
<ProductNDC>21695-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: microcrystalline cellulose, copovidone (plasdone-S630), sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, opadry white (OY-LS-58900), polysorbate 80.</Description>
</NDC>
<NDC>
<NDCCode>24385-067-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24385-067-10) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24385-0067-10</NDC11Code>
<ProductNDC>24385-067</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Nasal</ProprietaryName>
<ProprietaryNameSuffix>Extra Moisturizing</ProprietaryNameSuffix>
<NonProprietaryName>Oxymetazoline Hcl</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19950504</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19950504</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves nasal congestion due to:. common cold . hay fever . upper respiratory allergies. temporarily relieves sinus congestion and pressure. shrinks swollen nasal membranes so you can breathe more freely.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24724-067-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (24724-067-03)</PackageDescription>
<NDC11Code>24724-0067-03</NDC11Code>
<ProductNDC>24724-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207433</ApplicationNumber>
<LabelerName>INDICUS PHARMA LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Desipramine hydrochloride tablets, USP is indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5 H - Dibenz [bƒ] azepine - 5 - propanamine, 10, 11 - dihydro - N - methyl -, monohydrochloride. Inactive IngredientsThe following inactive ingredients are contained in all dosage strengths: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A (potato), stearic acid and hypromellose, talc, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-067-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (27241-067-03) </PackageDescription>
<NDC11Code>27241-0067-03</NDC11Code>
<ProductNDC>27241-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206401</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil citrate is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as green, oval-shaped, beveled edge, biconvex, film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide, FD & C Blue #1/brilliant blue FCF aluminum lake, D & C yellow # 10 aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>