{
"NDC": [
{
"NDCCode": "62337-415-16",
"PackageDescription": "473.2 mL in 1 BOTTLE, PLASTIC (62337-415-16) ",
"NDC11Code": "62337-0415-16",
"ProductNDC": "62337-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pyrantel Pamoate",
"NonProprietaryName": "Pinwormtreatment",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121017",
"EndMarketingDate": "20251030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M024",
"LabelerName": "Neogen Corporation dba Columbia Laboratories",
"SubstanceName": "PYRANTEL PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121017",
"EndMarketingDatePackage": "20251030",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of pinworms."
},
{
"NDCCode": "62337-415-32",
"PackageDescription": "946.4 mL in 1 BOTTLE, PLASTIC (62337-415-32) ",
"NDC11Code": "62337-0415-32",
"ProductNDC": "62337-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pyrantel Pamoate",
"NonProprietaryName": "Pinwormtreatment",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20121017",
"EndMarketingDate": "20251030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M024",
"LabelerName": "Neogen Corporation dba Columbia Laboratories",
"SubstanceName": "PYRANTEL PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121017",
"EndMarketingDatePackage": "20251030",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of pinworms."
},
{
"NDCCode": "21749-415-16",
"PackageDescription": "473 mL in 1 PACKAGE (21749-415-16) ",
"NDC11Code": "21749-0415-16",
"ProductNDC": "21749-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triclosan",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100310",
"EndMarketingDate": "20211201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100310",
"EndMarketingDatePackage": "20211201",
"SamplePackage": "N"
},
{
"NDCCode": "58980-415-16",
"PackageDescription": "16 BLISTER PACK in 1 BOX (58980-415-16) / 1 SUPPOSITORY in 1 BLISTER PACK",
"NDC11Code": "58980-0415-16",
"ProductNDC": "58980-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stratuscare Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20140530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Stratus Pharmaceuticals",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation and irregularity. this product generally produces bowel movement in 15 minutes to 1 hour."
},
{
"NDCCode": "74880-200-16",
"PackageDescription": "415.6 g in 1 BOTTLE (74880-200-16) ",
"NDC11Code": "74880-0200-16",
"ProductNDC": "74880-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bliss Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ExcelAg, Corp.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N"
},
{
"NDCCode": "0456-1214-11",
"PackageDescription": "10 CAPSULE in 1 BLISTER PACK (0456-1214-11) ",
"NDC11Code": "00456-1214-11",
"ProductNDC": "0456-1214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10; 14",
"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": "Deprecated",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is 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": "NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1228-11",
"PackageDescription": "10 CAPSULE in 1 BLISTER PACK (0456-1228-11) ",
"NDC11Code": "00456-1228-11",
"ProductNDC": "0456-1228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10; 28",
"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": "Deprecated",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is 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": "NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1229-04",
"PackageDescription": "1 KIT in 1 CARTON (0456-1229-04) * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION",
"NDC11Code": "00456-1229-04",
"ProductNDC": "0456-1229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "Y",
"IndicationAndUsage": "NAMZARIC is 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": "NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1229-29",
"PackageDescription": "1 BOX in 1 BOX (0456-1229-29) / 1 CARTON in 1 BOX / 1 KIT in 1 CARTON * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION",
"NDC11Code": "00456-1229-29",
"ProductNDC": "0456-1229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is 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": "NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0781-6206-75",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-75) / 5 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "00781-6206-75",
"ProductNDC": "0781-6206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20161206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202719",
"LabelerName": "Sandoz Inc",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161206",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: Bimatoprost 0.3 mg/mL; Preservative: Benzalkonium chloride 0.05 mg/mL; Inactives: Citric acid, purified water, sodium chloride and sodium phosphate dibasic. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "0781-6206-93",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-93) / 3 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "00781-6206-93",
"ProductNDC": "0781-6206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20161206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202719",
"LabelerName": "Sandoz Inc",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161206",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: Bimatoprost 0.3 mg/mL; Preservative: Benzalkonium chloride 0.05 mg/mL; Inactives: Citric acid, purified water, sodium chloride and sodium phosphate dibasic. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "10812-415-01",
"PackageDescription": "184 g in 1 CAN (10812-415-01)",
"NDC11Code": "10812-0415-01",
"ProductNDC": "10812-415",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Beach Defense Water Plus Sun Protection",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf70",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120605",
"EndMarketingDate": "20190215",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 150; 50; 40; 60",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-02-16",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "21695-415-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (21695-415-60)",
"NDC11Code": "21695-0415-60",
"ProductNDC": "21695-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089685",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), titanium dioxide, and polysorbate 80. Its structural formula is."
},
{
"NDCCode": "23390-1020-3",
"PackageDescription": "415 L in 1 CYLINDER (23390-1020-3) ",
"NDC11Code": "23390-1020-03",
"ProductNDC": "23390-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060505",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Denman Services, Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060505",
"SamplePackage": "N"
},
{
"NDCCode": "49766-2858-2",
"PackageDescription": "415 L in 1 CYLINDER (49766-2858-2) ",
"NDC11Code": "49766-2858-02",
"ProductNDC": "49766-2858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20091006",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Max's Breathe Easy Gases & Supplies, Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091006",
"SamplePackage": "N"
},
{
"NDCCode": "49770-0001-3",
"PackageDescription": "415 L in 1 CYLINDER (49770-0001-3) ",
"NDC11Code": "49770-0001-03",
"ProductNDC": "49770-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Alpha Oxy-Med LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091201",
"SamplePackage": "N"
},
{
"NDCCode": "52817-415-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (52817-415-10) ",
"NDC11Code": "52817-0415-10",
"ProductNDC": "52817-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206553",
"LabelerName": "TRUPHARMA, LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in alcohol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "52817-415-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (52817-415-50) ",
"NDC11Code": "52817-0415-50",
"ProductNDC": "52817-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206553",
"LabelerName": "TRUPHARMA, LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in alcohol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "62135-415-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62135-415-90) ",
"NDC11Code": "62135-0415-90",
"ProductNDC": "62135-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Hydrochloride",
"NonProprietaryName": "Fluphenazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215141",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221020",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below:. Fluphenazine Hydrochloride Tablets, USP for oral administration, contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains D&C Yellow No. 10 Al. Lake (2.5 mg and 5 mg tablets), FD&C Blue No. 1 Al. Lake (5 mg tablets), FD&C Yellow No. 6 Al. Lake (2.5 mg, 5 mg and 10 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, purified water, talc, and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "62332-507-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (62332-507-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "62332-0507-05",
"ProductNDC": "62332-507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210263",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190412",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "62332-507-25",
"PackageDescription": "1 BOTTLE in 1 CARTON (62332-507-25) / 2.5 mL in 1 BOTTLE",
"NDC11Code": "62332-0507-25",
"ProductNDC": "62332-507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20190412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210263",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190412",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "62332-511-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (62332-511-03) / 3 mL in 1 BOTTLE",
"NDC11Code": "62332-0511-03",
"ProductNDC": "62332-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210515",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200320",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R, 2R, 3R, 5S)-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf-life ranges from 6.8 to7.8."
},
{
"NDCCode": "62332-511-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (62332-511-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "62332-0511-05",
"ProductNDC": "62332-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20200121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210515",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200121",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.",
"Description": "Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R, 2R, 3R, 5S)-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf-life ranges from 6.8 to7.8."
},
{
"NDCCode": "63121-123-04",
"PackageDescription": "415 L in 1 CYLINDER (63121-123-04) ",
"NDC11Code": "63121-0123-04",
"ProductNDC": "63121-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960801",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "First Community Care",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100518",
"SamplePackage": "N"
},
{
"NDCCode": "68382-346-16",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-16) ",
"NDC11Code": "68382-0346-16",
"ProductNDC": "68382-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090175",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110511",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose."
},
{
"NDCCode": "68382-347-16",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-16) ",
"NDC11Code": "68382-0347-16",
"ProductNDC": "68382-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090175",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110511",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose."
},
{
"NDCCode": "68382-521-16",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68382-521-16) ",
"NDC11Code": "68382-0521-16",
"ProductNDC": "68382-521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203162",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180307",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride tablets are acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride tablet intended for oral administration contains 23 mg of donepezil hydrochloride (monohydrate), USP. In addition, each tablet contains the following inactive ingredients: corn starch, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. USP Dissolution Test pending."
},
{
"NDCCode": "69367-415-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01) ",
"NDC11Code": "69367-0415-01",
"ProductNDC": "69367-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Theophylline",
"ProprietaryNameSuffix": "(anhydrous)",
"NonProprietaryName": "Theophylline Anhydrous",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040560",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "THEOPHYLLINE ANHYDROUS",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251125",
"SamplePackage": "N",
"IndicationAndUsage": "Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
"Description": "Theophylline (Anhydrous) Extended-Release Tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients. Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula. The molecular formula of anhydrous theophylline is C7H8N4O2 with a molecular weight of 180.17. Each extended-release tablet for oral administration, contains 400 or 600 mg of anhydrous theophylline. Inactive ingredients: glyceryl behenate, silicified microcrystalline cellulose, silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "72789-415-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-415-90) ",
"NDC11Code": "72789-0415-90",
"ProductNDC": "72789-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C. Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is. Its molecular formula is C 23H 32N 2O 5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "82009-119-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (82009-119-05) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203034",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
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"IndicationAndUsage": "Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as 2, 3-Dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white to off white crystalline powder and is soluble in water, methanol and chloroform and sparingly soluble in acetic acid. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Meets Organic Impurities Test Procedure 2."
}
]
}
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
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<IndicationAndUsage>for relief of occasional constipation and irregularity. this product generally produces bowel movement in 15 minutes to 1 hour.</IndicationAndUsage>
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<PackageDescription>415.6 g in 1 BOTTLE (74880-200-16) </PackageDescription>
<NDC11Code>74880-0200-16</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Alcohol</NonProprietaryName>
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<LabelerName>ExcelAg, Corp.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<PackageDescription>10 CAPSULE in 1 BLISTER PACK (0456-1214-11) </PackageDescription>
<NDC11Code>00456-1214-11</NDC11Code>
<ProductNDC>0456-1214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 14</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>Deprecated</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is 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>NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1228-11</NDCCode>
<PackageDescription>10 CAPSULE in 1 BLISTER PACK (0456-1228-11) </PackageDescription>
<NDC11Code>00456-1228-11</NDC11Code>
<ProductNDC>0456-1228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 28</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>Deprecated</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is 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>NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1229-04</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0456-1229-04) * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION</PackageDescription>
<NDC11Code>00456-1229-04</NDC11Code>
<ProductNDC>0456-1229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>NAMZARIC is 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>NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1229-29</NDCCode>
<PackageDescription>1 BOX in 1 BOX (0456-1229-29) / 1 CARTON in 1 BOX / 1 KIT in 1 CARTON * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION</PackageDescription>
<NDC11Code>00456-1229-29</NDC11Code>
<ProductNDC>0456-1229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is 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>NAMZARIC contains 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. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0781-6206-75</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-75) / 5 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>00781-6206-75</NDC11Code>
<ProductNDC>0781-6206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20161206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202719</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: Bimatoprost 0.3 mg/mL; Preservative: Benzalkonium chloride 0.05 mg/mL; Inactives: Citric acid, purified water, sodium chloride and sodium phosphate dibasic. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0781-6206-93</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-93) / 3 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>00781-6206-93</NDC11Code>
<ProductNDC>0781-6206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20161206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202719</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-N-ethyl-5-heptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. Bimatoprost ophthalmic solution is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Contains: Active: Bimatoprost 0.3 mg/mL; Preservative: Benzalkonium chloride 0.05 mg/mL; Inactives: Citric acid, purified water, sodium chloride and sodium phosphate dibasic. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>10812-415-01</NDCCode>
<PackageDescription>184 g in 1 CAN (10812-415-01)</PackageDescription>
<NDC11Code>10812-0415-01</NDC11Code>
<ProductNDC>10812-415</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Beach Defense Water Plus Sun Protection</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf70</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120605</StartMarketingDate>
<EndMarketingDate>20190215</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 150; 50; 40; 60</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-16</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>21695-415-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (21695-415-60)</PackageDescription>
<NDC11Code>21695-0415-60</NDC11Code>
<ProductNDC>21695-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089685</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: lactose (monohydrate), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), titanium dioxide, and polysorbate 80. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>23390-1020-3</NDCCode>
<PackageDescription>415 L in 1 CYLINDER (23390-1020-3) </PackageDescription>
<NDC11Code>23390-1020-03</NDC11Code>
<ProductNDC>23390-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20060505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Denman Services, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49766-2858-2</NDCCode>
<PackageDescription>415 L in 1 CYLINDER (49766-2858-2) </PackageDescription>
<NDC11Code>49766-2858-02</NDC11Code>
<ProductNDC>49766-2858</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20091006</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Max's Breathe Easy Gases & Supplies, Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49770-0001-3</NDCCode>
<PackageDescription>415 L in 1 CYLINDER (49770-0001-3) </PackageDescription>
<NDC11Code>49770-0001-03</NDC11Code>
<ProductNDC>49770-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Alpha Oxy-Med LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52817-415-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (52817-415-10) </PackageDescription>
<NDC11Code>52817-0415-10</NDC11Code>
<ProductNDC>52817-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206553</ApplicationNumber>
<LabelerName>TRUPHARMA, LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in alcohol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>52817-415-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (52817-415-50) </PackageDescription>
<NDC11Code>52817-0415-50</NDC11Code>
<ProductNDC>52817-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206553</ApplicationNumber>
<LabelerName>TRUPHARMA, LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in alcohol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is:. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>62135-415-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62135-415-90) </PackageDescription>
<NDC11Code>62135-0415-90</NDC11Code>
<ProductNDC>62135-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluphenazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215141</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>FLUPHENAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below:. Fluphenazine Hydrochloride Tablets, USP for oral administration, contain 1 mg, 2.5 mg, 5 mg and 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains D&C Yellow No. 10 Al. Lake (2.5 mg and 5 mg tablets), FD&C Blue No. 1 Al. Lake (5 mg tablets), FD&C Yellow No. 6 Al. Lake (2.5 mg, 5 mg and 10 mg tablets), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, purified water, talc, and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>62332-507-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62332-507-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62332-0507-05</NDC11Code>
<ProductNDC>62332-507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210263</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>62332-507-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62332-507-25) / 2.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62332-0507-25</NDC11Code>
<ProductNDC>62332-507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20190412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210263</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1- pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution, 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL; disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>62332-511-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62332-511-03) / 3 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62332-0511-03</NDC11Code>
<ProductNDC>62332-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210515</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R, 2R, 3R, 5S)-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf-life ranges from 6.8 to7.8.</Description>
</NDC>
<NDC>
<NDCCode>62332-511-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62332-511-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62332-0511-05</NDC11Code>
<ProductNDC>62332-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20200121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210515</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[(1R, 2R, 3R, 5S)-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf-life ranges from 6.8 to7.8.</Description>
</NDC>
<NDC>
<NDCCode>63121-123-04</NDCCode>
<PackageDescription>415 L in 1 CYLINDER (63121-123-04) </PackageDescription>
<NDC11Code>63121-0123-04</NDC11Code>
<ProductNDC>63121-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>First Community Care</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-346-16</NDCCode>
<PackageDescription>90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-346-16) </PackageDescription>
<NDC11Code>68382-0346-16</NDC11Code>
<ProductNDC>68382-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090175</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>68382-347-16</NDCCode>
<PackageDescription>90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-347-16) </PackageDescription>
<NDC11Code>68382-0347-16</NDC11Code>
<ProductNDC>68382-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090175</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride orally disintegrating tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride orally disintegrating tablet, USP intended for oral administration contains 5 mg or 10 mg of donepezil hydrochloride. In addition, each tablet contains the following inactive ingredients: ammonium glycyrrhizate, colloidal silicon dioxide, crospovidone, flavor peppermint, flavor strawberry, magnesium stearate, mannitol and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>68382-521-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68382-521-16) </PackageDescription>
<NDC11Code>68382-0521-16</NDC11Code>
<ProductNDC>68382-521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203162</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1).</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Each donepezil hydrochloride tablet intended for oral administration contains 23 mg of donepezil hydrochloride (monohydrate), USP. In addition, each tablet contains the following inactive ingredients: corn starch, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>69367-415-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01) </PackageDescription>
<NDC11Code>69367-0415-01</NDC11Code>
<ProductNDC>69367-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Theophylline</ProprietaryName>
<ProprietaryNameSuffix>(anhydrous)</ProprietaryNameSuffix>
<NonProprietaryName>Theophylline Anhydrous</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040560</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>THEOPHYLLINE ANHYDROUS</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.</IndicationAndUsage>
<Description>Theophylline (Anhydrous) Extended-Release Tablets in a controlled-release system allows a 24-hour dosing interval for appropriate patients. Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula. The molecular formula of anhydrous theophylline is C7H8N4O2 with a molecular weight of 180.17. Each extended-release tablet for oral administration, contains 400 or 600 mg of anhydrous theophylline. Inactive ingredients: glyceryl behenate, silicified microcrystalline cellulose, silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72789-415-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (72789-415-90) </PackageDescription>
<NDC11Code>72789-0415-90</NDC11Code>
<ProductNDC>72789-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C. Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is. Its molecular formula is C 23H 32N 2O 5, and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>82009-119-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82009-119-05) </PackageDescription>
<NDC11Code>82009-0119-05</NDC11Code>
<ProductNDC>82009-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203034</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as 2, 3-Dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white to off white crystalline powder and is soluble in water, methanol and chloroform and sparingly soluble in acetic acid. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent. Meets Organic Impurities Test Procedure 2.</Description>
</NDC>
</NDCList>