{
"NDC": [
{
"NDCCode": "0168-0271-15",
"PackageDescription": "15 g in 1 TUBE (0168-0271-15) ",
"NDC11Code": "00168-0271-15",
"ProductNDC": "0168-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077061",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050328",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate,USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-. (2-furoate), with the molecular formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone furoate Ointment USP, 0.1% contains 1 mg mometasone furoate, USP in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol monostearate, white wax, white petrolatum, and purified water."
},
{
"NDCCode": "0168-0271-46",
"PackageDescription": "45 g in 1 TUBE (0168-0271-46) ",
"NDC11Code": "00168-0271-46",
"ProductNDC": "0168-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077061",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20050328",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate,USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-. (2-furoate), with the molecular formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone furoate Ointment USP, 0.1% contains 1 mg mometasone furoate, USP in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol monostearate, white wax, white petrolatum, and purified water."
},
{
"NDCCode": "21695-271-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (21695-271-15)",
"NDC11Code": "21695-0271-15",
"ProductNDC": "21695-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040769",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 750",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "43478-271-15",
"PackageDescription": "1 TUBE in 1 CARTON (43478-271-15) > 15 g in 1 TUBE",
"NDC11Code": "43478-0271-15",
"ProductNDC": "43478-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018652",
"LabelerName": "Rouses Point Pharm",
"SubstanceName": "HYDROCORTISONE BUTYRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50991-271-15",
"PackageDescription": "15 mL in 1 BOTTLE (50991-271-15) ",
"NDC11Code": "50991-0271-15",
"ProductNDC": "50991-271",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Poly-hist Dm",
"NonProprietaryName": "Dexchlorpheniramine Maleate And Dextromethorphan Hbr",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "POLY PHARMACEUTICALS, INC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DEXCHLORPHENIRAMINE MALEATE",
"StrengthNumber": "10; 1",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260423",
"SamplePackage": "N",
"IndicationAndUsage": ". Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 cough due to minor throat and bronchial irritation, 2 runny nose, 3 sneezing, 4 itching of nose or throat, 5 itchy, watery eyes."
},
{
"NDCCode": "52959-271-15",
"PackageDescription": "15 TABLET in 1 VIAL, PLASTIC (52959-271-15)",
"NDC11Code": "52959-0271-15",
"ProductNDC": "52959-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.",
"Description": "Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544."
},
{
"NDCCode": "53002-0271-2",
"PackageDescription": "15 TABLET in 1 BOTTLE (53002-0271-2) ",
"NDC11Code": "53002-0271-02",
"ProductNDC": "53002-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "66949-271-15",
"PackageDescription": "1200 mL in 1 BOTTLE, PLASTIC (66949-271-15) ",
"NDC11Code": "66949-0271-15",
"ProductNDC": "66949-271",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep E-2 Foaming Sanitizing Hand Cleaner",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"EndMarketingDate": "20190102",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Zep Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20111001",
"EndMarketingDatePackage": "20190102",
"SamplePackage": "N"
},
{
"NDCCode": "68682-271-15",
"PackageDescription": "1 TUBE in 1 CARTON (68682-271-15) > 15 g in 1 TUBE",
"NDC11Code": "68682-0271-15",
"ProductNDC": "68682-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Butyrate",
"NonProprietaryName": "Hydrocortisone Butyrate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018652",
"LabelerName": "Oceanside Pharmaceuticals",
"SubstanceName": "HYDROCORTISONE BUTYRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2021-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Hydrocortisone Butyrate Ointment, 0.1% contains the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is. Each gram of Hydrocortisone Butyrate Ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene."
},
{
"NDCCode": "71205-271-15",
"PackageDescription": "1 TUBE in 1 CARTON (71205-271-15) > 15 g in 1 TUBE",
"NDC11Code": "71205-0271-15",
"ProductNDC": "71205-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desoximetasone",
"NonProprietaryName": "Desoximetasone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205082",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DESOXIMETASONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "Desoximetasone cream USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Desoximetasone cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. The chemical name of desoximetasone, USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone, USP has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is."
},
{
"NDCCode": "76420-271-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (76420-271-15) ",
"NDC11Code": "76420-0271-15",
"ProductNDC": "76420-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071611",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220903",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5 H- dibenzo[a,d]cyclohepten-5-ylidene)- N , N -dimethyl-1- propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "78475-271-15",
"PackageDescription": "1893 mL in 1 BOTTLE, PLASTIC (78475-271-15) ",
"NDC11Code": "78475-0271-15",
"ProductNDC": "78475-271",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200617",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Laboratorios Lemuel SRL",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200617",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "85766-271-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (85766-271-15) ",
"NDC11Code": "85766-0271-15",
"ProductNDC": "85766-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209553",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260905",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir Tablets, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4∙HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "0168-0002-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0002-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0002-15",
"ProductNDC": "0168-0002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0003-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0003-15",
"ProductNDC": "0168-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0004-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0004-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0004-15",
"ProductNDC": "0168-0004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0006-15",
"PackageDescription": "15 g in 1 TUBE (0168-0006-15) ",
"NDC11Code": "00168-0006-15",
"ProductNDC": "0168-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780214",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C24H31FO6 and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "0168-0007-15",
"PackageDescription": "15 g in 1 TUBE (0168-0007-15) ",
"NDC11Code": "00168-0007-15",
"ProductNDC": "0168-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19820923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062124",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19820923",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.",
"Description": "Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows."
},
{
"NDCCode": "0168-0033-15",
"PackageDescription": "15 g in 1 TUBE (0168-0033-15) ",
"NDC11Code": "00168-0033-15",
"ProductNDC": "0168-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19830831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018865",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830831",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "0168-0040-15",
"PackageDescription": "15 g in 1 TUBE (0168-0040-15) ",
"NDC11Code": "00168-0040-15",
"ProductNDC": "0168-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19830831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018861",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830831",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "0168-0054-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE",
"NDC11Code": "00168-0054-15",
"ProductNDC": "0168-0054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19790201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062129",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19790201",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Molecular Weight 926.13. Molecular Formula C47H75NO17. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone Emulsion, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water."
},
{
"NDCCode": "0168-0055-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0055-15",
"ProductNDC": "0168-0055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019137",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840626",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required."
},
{
"NDCCode": "0168-0056-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0056-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0056-15",
"ProductNDC": "0168-0056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019141",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840904",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone dipropionate ointment, USP contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Molecular Formula: C28H37FO7. Molecular Weight: 504.60. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "0168-0058-15",
"PackageDescription": "15 g in 1 TUBE (0168-0058-15)",
"NDC11Code": "00168-0058-15",
"ProductNDC": "0168-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088170",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0060-15",
"PackageDescription": "15 g in 1 TUBE (0168-0060-15)",
"NDC11Code": "00168-0060-15",
"ProductNDC": "0168-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088169",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0064-15",
"PackageDescription": "15 g in 1 TUBE (0168-0064-15) ",
"NDC11Code": "00168-0064-15",
"ProductNDC": "0168-0064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088168",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19821216",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of. C24H30F2O6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum."
},
{
"NDCCode": "0168-0071-15",
"PackageDescription": "15 g in 1 TUBE (0168-0071-15)",
"NDC11Code": "00168-0071-15",
"ProductNDC": "0168-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062531",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0168-0078-15",
"PackageDescription": "15 g in 1 TUBE (0168-0078-15)",
"NDC11Code": "00168-0078-15",
"ProductNDC": "0168-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062533",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "GENTAMICIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment may be used in children over one year of age as well as in adults.",
"Description": "Gentamicin Sulfate Ointment is a wide spectrum antibiotic preparation for topical administration. Each gram contains 1.0 mg of Gentamicin in a base of White Petrolatum with Methylparaben and Propylparaben as preservatives."
},
{
"NDCCode": "0168-0081-15",
"PackageDescription": "15 g in 1 TUBE (0168-0081-15) ",
"NDC11Code": "00168-0081-15",
"ProductNDC": "0168-0081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062599",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19851008",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and triamcinolone acetonide cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Structural formula:. Nystatin and triamcinolone acetonide cream is a soft, smooth cream having a light yellow to tan color. Each gram of nystatin and triamcinolone acetonide cream USP contains 100,000 USP Nystatin Units and 1 mg of triamcinolone acetonide in a cream base containing polyoxyethylene fatty alcohol ether, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, sorbitol solution, simethicone emulsion, propylene glycol, aluminum hydroxide gel, polysorbate 60, titanium dioxide, and purified water with benzyl alcohol as a preservative. Sodium hydroxide to adjust pH."
},
{
"NDCCode": "0168-0089-15",
"PackageDescription": "15 g in 1 TUBE (0168-0089-15) ",
"NDC11Code": "00168-0089-15",
"ProductNDC": "0168-0089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062602",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19851009",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment .",
"Description": "Nystatin and triamcinolone acetonide ointment, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Each gram of nystatin and triamcinolone acetonide ointment contains 100,000 USP nystatin units and 1 mg of triamcinolone acetonide in a base of polyethylene and mineral oil."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0168-0271-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0271-15) </PackageDescription>
<NDC11Code>00168-0271-15</NDC11Code>
<ProductNDC>0168-0271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077061</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-25</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate,USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-. (2-furoate), with the molecular formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone furoate Ointment USP, 0.1% contains 1 mg mometasone furoate, USP in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol monostearate, white wax, white petrolatum, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0271-46</NDCCode>
<PackageDescription>45 g in 1 TUBE (0168-0271-46) </PackageDescription>
<NDC11Code>00168-0271-46</NDC11Code>
<ProductNDC>0168-0271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077061</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate,USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-. (2-furoate), with the molecular formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone furoate Ointment USP, 0.1% contains 1 mg mometasone furoate, USP in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol monostearate, white wax, white petrolatum, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>21695-271-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (21695-271-15)</PackageDescription>
<NDC11Code>21695-0271-15</NDC11Code>
<ProductNDC>21695-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040769</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 750</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43478-271-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43478-271-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>43478-0271-15</NDC11Code>
<ProductNDC>43478-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018652</ApplicationNumber>
<LabelerName>Rouses Point Pharm</LabelerName>
<SubstanceName>HYDROCORTISONE BUTYRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50991-271-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (50991-271-15) </PackageDescription>
<NDC11Code>50991-0271-15</NDC11Code>
<ProductNDC>50991-271</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Poly-hist Dm</ProprietaryName>
<NonProprietaryName>Dexchlorpheniramine Maleate And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>POLY PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DEXCHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>10; 1</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 cough due to minor throat and bronchial irritation, 2 runny nose, 3 sneezing, 4 itching of nose or throat, 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-271-15</NDCCode>
<PackageDescription>15 TABLET in 1 VIAL, PLASTIC (52959-271-15)</PackageDescription>
<NDC11Code>52959-0271-15</NDC11Code>
<ProductNDC>52959-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as naproxen or naproxen sodium tablets are indicated: : 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis.</IndicationAndUsage>
<Description>Naproxen USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen USP and naproxen sodium USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen USP and naproxen sodium USP have the following structures, respectively:. Naproxen USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen USP at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen tablets USP are available as light orange colored tablets containing 250 mg of naproxen USP, light orange colored tablets containing 375 mg of naproxen USP and light orange colored tablets containing 500 mg of naproxen USP for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxides, povidone and magnesium stearate. Naproxen sodium tablets USP are available as blue tablets containing 275 mg of naproxen sodium USP and as blue tablets containing 550 mg of naproxen sodium USP for oral administration. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg tablet may contain Opadry blue 03F50544. The coating suspension for the naproxen sodium 550 mg tablet may contain Opadry blue 03F50544.</Description>
</NDC>
<NDC>
<NDCCode>53002-0271-2</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (53002-0271-2) </PackageDescription>
<NDC11Code>53002-0271-02</NDC11Code>
<ProductNDC>53002-0271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>66949-271-15</NDCCode>
<PackageDescription>1200 mL in 1 BOTTLE, PLASTIC (66949-271-15) </PackageDescription>
<NDC11Code>66949-0271-15</NDC11Code>
<ProductNDC>66949-271</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zep E-2 Foaming Sanitizing Hand Cleaner</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<EndMarketingDate>20190102</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Zep Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20111001</StartMarketingDatePackage>
<EndMarketingDatePackage>20190102</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68682-271-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68682-271-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>68682-0271-15</NDC11Code>
<ProductNDC>68682-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Butyrate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Butyrate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018652</ApplicationNumber>
<LabelerName>Oceanside Pharmaceuticals</LabelerName>
<SubstanceName>HYDROCORTISONE BUTYRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Hydrocortisone Butyrate Ointment, 0.1% contains the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is. Each gram of Hydrocortisone Butyrate Ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene.</Description>
</NDC>
<NDC>
<NDCCode>71205-271-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (71205-271-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>71205-0271-15</NDC11Code>
<ProductNDC>71205-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desoximetasone</ProprietaryName>
<NonProprietaryName>Desoximetasone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205082</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DESOXIMETASONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desoximetasone cream USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Desoximetasone cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone, USP. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of desoximetasone cream USP, 0.25% contains 2.5 mg of desoximetasone, USP in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum. The chemical name of desoximetasone, USP is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone, USP has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>76420-271-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (76420-271-15) </PackageDescription>
<NDC11Code>76420-0271-15</NDC11Code>
<ProductNDC>76420-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071611</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5 H- dibenzo[a,d]cyclohepten-5-ylidene)- N , N -dimethyl-1- propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>78475-271-15</NDCCode>
<PackageDescription>1893 mL in 1 BOTTLE, PLASTIC (78475-271-15) </PackageDescription>
<NDC11Code>78475-0271-15</NDC11Code>
<ProductNDC>78475-271</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200617</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Laboratorios Lemuel SRL</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85766-271-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (85766-271-15) </PackageDescription>
<NDC11Code>85766-0271-15</NDC11Code>
<ProductNDC>85766-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209553</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir Tablets, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4∙HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>0168-0002-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0002-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0002-15</NDC11Code>
<ProductNDC>0168-0002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0003-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0003-15</NDC11Code>
<ProductNDC>0168-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0004-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0004-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0004-15</NDC11Code>
<ProductNDC>0168-0004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0006-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0006-15) </PackageDescription>
<NDC11Code>00168-0006-15</NDC11Code>
<ProductNDC>0168-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085691</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C24H31FO6 and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil.</Description>
</NDC>
<NDC>
<NDCCode>0168-0007-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0007-15) </PackageDescription>
<NDC11Code>00168-0007-15</NDC11Code>
<ProductNDC>0168-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19820923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062124</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.</IndicationAndUsage>
<Description>Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>0168-0033-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0033-15) </PackageDescription>
<NDC11Code>00168-0033-15</NDC11Code>
<ProductNDC>0168-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018865</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0040-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0040-15) </PackageDescription>
<NDC11Code>00168-0040-15</NDC11Code>
<ProductNDC>0168-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018861</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0054-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0054-15</NDC11Code>
<ProductNDC>0168-0054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19790201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062129</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Molecular Weight 926.13. Molecular Formula C47H75NO17. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone Emulsion, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0055-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0055-15</NDC11Code>
<ProductNDC>0168-0055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019137</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required.</Description>
</NDC>
<NDC>
<NDCCode>0168-0056-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0056-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0056-15</NDC11Code>
<ProductNDC>0168-0056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019141</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone dipropionate ointment, USP contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Molecular Formula: C28H37FO7. Molecular Weight: 504.60. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0168-0058-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0058-15)</PackageDescription>
<NDC11Code>00168-0058-15</NDC11Code>
<ProductNDC>0168-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088170</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0060-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0060-15)</PackageDescription>
<NDC11Code>00168-0060-15</NDC11Code>
<ProductNDC>0168-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088169</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0064-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0064-15) </PackageDescription>
<NDC11Code>00168-0064-15</NDC11Code>
<ProductNDC>0168-0064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088168</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of. C24H30F2O6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0168-0071-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0071-15)</PackageDescription>
<NDC11Code>00168-0071-15</NDC11Code>
<ProductNDC>0168-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062531</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0078-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0078-15)</PackageDescription>
<NDC11Code>00168-0078-15</NDC11Code>
<ProductNDC>0168-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062533</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GENTAMICIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment may be used in children over one year of age as well as in adults.</IndicationAndUsage>
<Description>Gentamicin Sulfate Ointment is a wide spectrum antibiotic preparation for topical administration. Each gram contains 1.0 mg of Gentamicin in a base of White Petrolatum with Methylparaben and Propylparaben as preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0168-0081-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0081-15) </PackageDescription>
<NDC11Code>00168-0081-15</NDC11Code>
<ProductNDC>0168-0081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062599</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and triamcinolone acetonide cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Structural formula:. Nystatin and triamcinolone acetonide cream is a soft, smooth cream having a light yellow to tan color. Each gram of nystatin and triamcinolone acetonide cream USP contains 100,000 USP Nystatin Units and 1 mg of triamcinolone acetonide in a cream base containing polyoxyethylene fatty alcohol ether, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, sorbitol solution, simethicone emulsion, propylene glycol, aluminum hydroxide gel, polysorbate 60, titanium dioxide, and purified water with benzyl alcohol as a preservative. Sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0089-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0089-15) </PackageDescription>
<NDC11Code>00168-0089-15</NDC11Code>
<ProductNDC>0168-0089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062602</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment .</IndicationAndUsage>
<Description>Nystatin and triamcinolone acetonide ointment, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Each gram of nystatin and triamcinolone acetonide ointment contains 100,000 USP nystatin units and 1 mg of triamcinolone acetonide in a base of polyethylene and mineral oil.</Description>
</NDC>
</NDCList>