{
"NDC": [
{
"NDCCode": "60290-057-03",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (60290-057-03) ",
"NDC11Code": "60290-0057-03",
"ProductNDC": "60290-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium Tablets",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215750",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220512",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide."
},
{
"NDCCode": "60290-057-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (60290-057-01) ",
"NDC11Code": "60290-0057-01",
"ProductNDC": "60290-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium Tablets",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215750",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220512",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide."
},
{
"NDCCode": "60290-057-02",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-057-02) ",
"NDC11Code": "60290-0057-02",
"ProductNDC": "60290-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium Tablets",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215750",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220512",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide."
},
{
"NDCCode": "42292-057-03",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01) ",
"NDC11Code": "42292-0057-03",
"ProductNDC": "42292-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200603",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208446",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200603",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "42961-057-03",
"PackageDescription": "50 PACKET in 1 BOX (42961-057-03) / .7 mL in 1 PACKET (42961-057-01) ",
"NDC11Code": "42961-0057-03",
"ProductNDC": "42961-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zee Clean Wipes",
"NonProprietaryName": "Alcohol Wipes",
"DosageFormName": "SPONGE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230126",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Cintas Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/.7mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230126",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "43826-057-03",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43826-057-03) ",
"NDC11Code": "43826-0057-03",
"ProductNDC": "43826-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203104",
"LabelerName": "Bora Pharmaceutical Laboratories Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "23",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150922",
"SamplePackage": "N",
"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 tablets USP are 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 an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, sodium hydroxide, triethyl citrate, iron oxide black, and propylene glycol. USP Dissolution Test pending. USP Organic Impurities Test pending."
},
{
"NDCCode": "49967-057-03",
"PackageDescription": "1 TUBE in 1 CARTON (49967-057-03) / 60 mL in 1 TUBE",
"NDC11Code": "49967-0057-03",
"ProductNDC": "49967-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating And Preventing",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "12",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230601",
"SamplePackage": "N",
"IndicationAndUsage": "for the treatment of acne. clears acne blemishes and allows skin to heal. helps keep skin clear of new acne blemishes."
},
{
"NDCCode": "52536-057-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (52536-057-03) ",
"NDC11Code": "52536-0057-03",
"ProductNDC": "52536-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphetamine Sulfate",
"NonProprietaryName": "Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200166",
"LabelerName": "Wilshire Pharmaceuticals, Inc.",
"SubstanceName": "AMPHETAMINE SULFATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210107",
"SamplePackage": "N",
"IndicationAndUsage": "Amphetamine Sulfate Tablets, USP, are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient's refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .",
"Description": "Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula."
},
{
"NDCCode": "62082-057-03",
"PackageDescription": "100 mL in 1 TUBE (62082-057-03) ",
"NDC11Code": "62082-0057-03",
"ProductNDC": "62082-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharmaca Natural Mineral Sunscreen Spf-50",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Pharmaca Integrative Pharmacy, Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "60; 225",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "65162-057-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03) ",
"NDC11Code": "65162-0057-03",
"ProductNDC": "65162-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raloxifene Hydrochloride",
"NonProprietaryName": "Raloxifene Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208206",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "RALOXIFENE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160120",
"SamplePackage": "N",
"IndicationAndUsage": "Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2), 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3).",
"Description": "Raloxifene hydrochloride is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride has the molecular formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene hydrochloride, USP is off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet, USP contains 60 mg of raloxifene hydrochloride, USP, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide and titanium dioxide."
},
{
"NDCCode": "66472-057-03",
"PackageDescription": "10 mL in 1 BOTTLE (66472-057-03) ",
"NDC11Code": "66472-0057-03",
"ProductNDC": "66472-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benefit Hello Happy Flawless Brightening Foundation Spf15",
"ProprietaryNameSuffix": "Shade 2",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Benefit Cosmetics, LLC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 40.2",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190804",
"SamplePackage": "N"
},
{
"NDCCode": "66902-057-03",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (66902-057-03) / 73 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "66902-0057-03",
"ProductNDC": "66902-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief With Lavender",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Natural Essentials, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "38",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210122",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain."
},
{
"NDCCode": "69804-057-03",
"PackageDescription": "113400 mg in 1 JAR (69804-057-03)",
"NDC11Code": "69804-0057-03",
"ProductNDC": "69804-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Postherpetic Neuralgia Care",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "ridge properties",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1000mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69844-057-03",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (69844-057-03) ",
"NDC11Code": "69844-0057-03",
"ProductNDC": "69844-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207099",
"LabelerName": "Graviti Pharmaceuticals Private Limited",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Capsules are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: corn starch and magnesium stearate. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains FD&C Blue No. 1 Aluminum Lake, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "71052-057-03",
"PackageDescription": "10 g in 1 BOTTLE (71052-057-03)",
"NDC11Code": "71052-0057-03",
"ProductNDC": "71052-057",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20161107",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Darmerica, LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71209-057-03",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71209-057-03) ",
"NDC11Code": "71209-0057-03",
"ProductNDC": "71209-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208701",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180823",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: lactose monohydrate, crospovidone, sodium lauryl sulphate, polyvinyl pyrrolidone, magnesium stearate and gelatin. The gelatin capsule shell of the 50 mg strength contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 100 mg strength contains FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 200 mg strength contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 400 mg strength contains FD&C blue 1, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The dyes of the imprinting ink for 50 mg, 100 mg, 200 mg and 400 mg strength contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "72005-057-03",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (72005-057-03) ",
"NDC11Code": "72005-0057-03",
"ProductNDC": "72005-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cotton Candy Scented Hand Sanitizer",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Alochol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200526",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Townley Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200526",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N"
},
{
"NDCCode": "73569-057-03",
"PackageDescription": "10 g in 1 BOTTLE (73569-057-03) ",
"NDC11Code": "73569-0057-03",
"ProductNDC": "73569-057",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxytocin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Peptites Biotech",
"SubstanceName": "OXYTOCIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-NOV-24"
},
{
"NDCCode": "84515-057-03",
"PackageDescription": "30 g in 1 BOX (84515-057-03) ",
"NDC11Code": "84515-0057-03",
"ProductNDC": "84515-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Moisturizer Face Cream",
"NonProprietaryName": "Trstay Moisturizer Face Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240828",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E - Commerce Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240828",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N"
},
{
"NDCCode": "84525-057-03",
"PackageDescription": "30 g in 1 BOX (84525-057-03) ",
"NDC11Code": "84525-0057-03",
"ProductNDC": "84525-057",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Super C Face Cream",
"NonProprietaryName": "Super C Face Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240828",
"EndMarketingDate": "20310822",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Guangzhou Lifubao Cocmetics Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240828",
"EndMarketingDatePackage": "20310822",
"SamplePackage": "N"
},
{
"NDCCode": "85207-057-03",
"PackageDescription": "10 g in 1 BAG (85207-057-03) ",
"NDC11Code": "85207-0057-03",
"ProductNDC": "85207-057",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Elamipretide (ss-31) Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260318",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "SCH Global Services Private Limited",
"SubstanceName": "ELAMIPRETIDE",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Unfinished",
"LastUpdate": "2026-03-19",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "18-MAR-26"
},
{
"NDCCode": "60290-002-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-002-03) ",
"NDC11Code": "60290-0002-03",
"ProductNDC": "60290-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209302",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "60290-003-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60290-003-03) ",
"NDC11Code": "60290-0003-03",
"ProductNDC": "60290-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil Citrate",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209302",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "60290-009-03",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-009-03) ",
"NDC11Code": "60290-0009-03",
"ProductNDC": "60290-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207135",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "60290-010-03",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-010-03) ",
"NDC11Code": "60290-0010-03",
"ProductNDC": "60290-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207135",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "60290-011-03",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (60290-011-03) ",
"NDC11Code": "60290-0011-03",
"ProductNDC": "60290-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207135",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3."
},
{
"NDCCode": "60290-016-03",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-016-03) ",
"NDC11Code": "60290-0016-03",
"ProductNDC": "60290-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210628",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
},
{
"NDCCode": "60290-017-03",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-017-03) ",
"NDC11Code": "60290-0017-03",
"ProductNDC": "60290-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210628",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
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"LabelerName": "Umedica Laboratories USA Inc.",
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"Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
},
{
"NDCCode": "60290-019-03",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (60290-019-03) ",
"NDC11Code": "60290-0019-03",
"ProductNDC": "60290-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
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"RouteName": "ORAL",
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"ApplicationNumber": "ANDA210628",
"LabelerName": "Umedica Laboratories USA Inc.",
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"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution."
}
]
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<Description>Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide.</Description>
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<NDC>
<NDCCode>60290-057-02</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60290-057-02) </PackageDescription>
<NDC11Code>60290-0057-02</NDC11Code>
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<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 25 mg and 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide.</Description>
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<NDC>
<NDCCode>42292-057-03</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01) </PackageDescription>
<NDC11Code>42292-0057-03</NDC11Code>
<ProductNDC>42292-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200603</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208446</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200603</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>42961-057-03</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (42961-057-03) / .7 mL in 1 PACKET (42961-057-01) </PackageDescription>
<NDC11Code>42961-0057-03</NDC11Code>
<ProductNDC>42961-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zee Clean Wipes</ProprietaryName>
<NonProprietaryName>Alcohol Wipes</NonProprietaryName>
<DosageFormName>SPONGE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230126</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Cintas Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/.7mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43826-057-03</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43826-057-03) </PackageDescription>
<NDC11Code>43826-0057-03</NDC11Code>
<ProductNDC>43826-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203104</ApplicationNumber>
<LabelerName>Bora Pharmaceutical Laboratories 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>2024-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150922</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 tablets USP are 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 an empirical formula of C 24H 29NO 3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride. Inactive ingredients in 23 mg tablets include hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, sodium hydroxide, triethyl citrate, iron oxide black, and propylene glycol. USP Dissolution Test pending. USP Organic Impurities Test pending.</Description>
</NDC>
<NDC>
<NDCCode>49967-057-03</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49967-057-03) / 60 mL in 1 TUBE</PackageDescription>
<NDC11Code>49967-0057-03</NDC11Code>
<ProductNDC>49967-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating And Preventing</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the treatment of acne. clears acne blemishes and allows skin to heal. helps keep skin clear of new acne blemishes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52536-057-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52536-057-03) </PackageDescription>
<NDC11Code>52536-0057-03</NDC11Code>
<ProductNDC>52536-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200166</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphetamine Sulfate Tablets, USP, are indicated for: 1 Narcolepsy, 2 Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. , 3 Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient's refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below. .</IndicationAndUsage>
<Description>Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5.0 to 6.0. It is freely soluble in water and slightly soluble in alcohol. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>62082-057-03</NDCCode>
<PackageDescription>100 mL in 1 TUBE (62082-057-03) </PackageDescription>
<NDC11Code>62082-0057-03</NDC11Code>
<ProductNDC>62082-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharmaca Natural Mineral Sunscreen Spf-50</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Pharmaca Integrative Pharmacy, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>60; 225</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-057-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03) </PackageDescription>
<NDC11Code>65162-0057-03</NDC11Code>
<ProductNDC>65162-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
<NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208206</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2), 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3).</IndicationAndUsage>
<Description>Raloxifene hydrochloride is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride has the molecular formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene hydrochloride, USP is off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet, USP contains 60 mg of raloxifene hydrochloride, USP, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>66472-057-03</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (66472-057-03) </PackageDescription>
<NDC11Code>66472-0057-03</NDC11Code>
<ProductNDC>66472-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benefit Hello Happy Flawless Brightening Foundation Spf15</ProprietaryName>
<ProprietaryNameSuffix>Shade 2</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Benefit Cosmetics, LLC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 40.2</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66902-057-03</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (66902-057-03) / 73 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>66902-0057-03</NDC11Code>
<ProductNDC>66902-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief With Lavender</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Natural Essentials, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>38</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69804-057-03</NDCCode>
<PackageDescription>113400 mg in 1 JAR (69804-057-03)</PackageDescription>
<NDC11Code>69804-0057-03</NDC11Code>
<ProductNDC>69804-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Postherpetic Neuralgia Care</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>ridge properties</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69844-057-03</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (69844-057-03) </PackageDescription>
<NDC11Code>69844-0057-03</NDC11Code>
<ProductNDC>69844-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170324</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207099</ApplicationNumber>
<LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Capsules are indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin capsules, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: corn starch and magnesium stearate. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The imprinting ink contains FD&C Blue No. 1 Aluminum Lake, propylene glycol, shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71052-057-03</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (71052-057-03)</PackageDescription>
<NDC11Code>71052-0057-03</NDC11Code>
<ProductNDC>71052-057</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20161107</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Darmerica, LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71209-057-03</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71209-057-03) </PackageDescription>
<NDC11Code>71209-0057-03</NDC11Code>
<ProductNDC>71209-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208701</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: lactose monohydrate, crospovidone, sodium lauryl sulphate, polyvinyl pyrrolidone, magnesium stearate and gelatin. The gelatin capsule shell of the 50 mg strength contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 100 mg strength contains FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 200 mg strength contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 400 mg strength contains FD&C blue 1, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The dyes of the imprinting ink for 50 mg, 100 mg, 200 mg and 400 mg strength contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>72005-057-03</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (72005-057-03) </PackageDescription>
<NDC11Code>72005-0057-03</NDC11Code>
<ProductNDC>72005-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cotton Candy Scented Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alochol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200526</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Townley Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200526</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73569-057-03</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (73569-057-03) </PackageDescription>
<NDC11Code>73569-0057-03</NDC11Code>
<ProductNDC>73569-057</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxytocin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Peptites Biotech</LabelerName>
<SubstanceName>OXYTOCIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-NOV-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84515-057-03</NDCCode>
<PackageDescription>30 g in 1 BOX (84515-057-03) </PackageDescription>
<NDC11Code>84515-0057-03</NDC11Code>
<ProductNDC>84515-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Moisturizer Face Cream</ProprietaryName>
<NonProprietaryName>Trstay Moisturizer Face Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E - Commerce Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240828</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84525-057-03</NDCCode>
<PackageDescription>30 g in 1 BOX (84525-057-03) </PackageDescription>
<NDC11Code>84525-0057-03</NDC11Code>
<ProductNDC>84525-057</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Super C Face Cream</ProprietaryName>
<NonProprietaryName>Super C Face Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<EndMarketingDate>20310822</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Guangzhou Lifubao Cocmetics Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240828</StartMarketingDatePackage>
<EndMarketingDatePackage>20310822</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85207-057-03</NDCCode>
<PackageDescription>10 g in 1 BAG (85207-057-03) </PackageDescription>
<NDC11Code>85207-0057-03</NDC11Code>
<ProductNDC>85207-057</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Elamipretide (ss-31) Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260318</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>SCH Global Services Private Limited</LabelerName>
<SubstanceName>ELAMIPRETIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-03-19</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-MAR-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60290-002-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60290-002-03) </PackageDescription>
<NDC11Code>60290-0002-03</NDC11Code>
<ProductNDC>60290-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209302</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60290-003-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60290-003-03) </PackageDescription>
<NDC11Code>60290-0003-03</NDC11Code>
<ProductNDC>60290-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil Citrate</ProprietaryName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209302</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>60290-009-03</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (60290-009-03) </PackageDescription>
<NDC11Code>60290-0009-03</NDC11Code>
<ProductNDC>60290-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207135</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2026-10-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 1 H-Imidazole-5-Carboxylic Acid, 4-(1-Hydroxy-1-Methylethyl)-2-Propyl-1-[[2'-1 H-Tetrazol-5yl)[1, 1'-Biphenyl]-4-yl]Methyl]-, (5-Methyl-2-Oxo-1, 3-Dioxol-4-yl) Methyl Ester. Its empirical formula is C 29H 30N 6O 6and its structural formula is:. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.59. It is slightly soluble in acetone and methanol, very slightly soluble in ethanol. Practically insoluble in water. Olmesartan medoxomil tablets, USP are available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low substituted hydroxyl propyl cellulose, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. Meets USP Dissolution Test 3.</Description>
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<NDC>
<NDCCode>60290-016-03</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (60290-016-03) </PackageDescription>
<NDC11Code>60290-0016-03</NDC11Code>
<ProductNDC>60290-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210628</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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<PackageDescription>500 CAPSULE in 1 BOTTLE (60290-017-03) </PackageDescription>
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<ProductNDC>60290-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210628</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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<NDC>
<NDCCode>60290-018-03</NDCCode>
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<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white or almost white, crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: lactose monohydrate, croscarmellose sodium, povidone, sodium lauryl sulphate and magnesium stearate. The content of empty hard gelatin capsules: titanium dioxide, gelatin, sodium lauryl sulphate. The content of edible ink: shellac, propylene glycol, black iron oxide, potassium hydroxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol and strong ammonia solution.</Description>
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