{
"NDC": [
{
"NDCCode": "45802-961-26",
"PackageDescription": "118 mL in 1 BOTTLE (45802-961-26) ",
"NDC11Code": "45802-0961-26",
"ProductNDC": "45802-961",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090974",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120810",
"SamplePackage": "N",
"Description": "Clobetasol Propionate Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate."
},
{
"NDCCode": "45802-133-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-133-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0133-26",
"ProductNDC": "45802-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074937",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever."
},
{
"NDCCode": "45802-140-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-140-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0140-26",
"ProductNDC": "45802-140",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074937",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever."
},
{
"NDCCode": "45802-201-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-201-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0201-26",
"ProductNDC": "45802-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140409",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:the common coldfluheadachesore throattoothache."
},
{
"NDCCode": "45802-203-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-203-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0203-26",
"ProductNDC": "45802-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20140409",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140409",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:the common coldfluheadachesore throattoothache."
},
{
"NDCCode": "45802-419-26",
"PackageDescription": "400 g in 1 BOTTLE, PLASTIC (45802-419-26) ",
"NDC11Code": "45802-0419-26",
"ProductNDC": "45802-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075570",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Acidifying Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060620",
"SamplePackage": "N",
"IndicationAndUsage": "Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.",
"Description": "*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "45802-485-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-485-26) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "45802-0485-26",
"ProductNDC": "45802-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202848",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".01",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults.",
"Description": "Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11, 21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes."
},
{
"NDCCode": "45802-493-26",
"PackageDescription": "385 g in 1 BOTTLE, PUMP (45802-493-26) ",
"NDC11Code": "45802-0493-26",
"ProductNDC": "45802-493",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075774",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Acidifying Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070219",
"SamplePackage": "N",
"IndicationAndUsage": "Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.",
"Description": "*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "45802-626-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE",
"NDC11Code": "45802-0626-26",
"ProductNDC": "45802-626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20080724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078398",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080724",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [ (4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the solution are: banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate anhydrous, sucrose, and water."
},
{
"NDCCode": "45802-887-26",
"PackageDescription": "118.28 mL in 1 BOTTLE (45802-887-26) ",
"NDC11Code": "45802-0887-26",
"ProductNDC": "45802-887",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202847",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".01",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170614",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil is indicated for the topical treatment of: 1 atopic dermatitis in adults , 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older.",
"Description": "Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes."
},
{
"NDCCode": "45802-896-26",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (45802-896-26) ",
"NDC11Code": "45802-0896-26",
"ProductNDC": "45802-896",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfacetamide Sodium",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078649",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121017",
"SamplePackage": "N",
"IndicationAndUsage": "Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris.",
"Description": "Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is."
},
{
"NDCCode": "45802-897-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-897-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0897-26",
"ProductNDC": "45802-897",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20111117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074937",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111117",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever."
},
{
"NDCCode": "45802-913-26",
"PackageDescription": "113 g in 1 BOTTLE (45802-913-26)",
"NDC11Code": "45802-0913-26",
"ProductNDC": "45802-913",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Wash",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "45802-937-26",
"PackageDescription": "118 mL in 1 BOTTLE (45802-937-26) ",
"NDC11Code": "45802-0937-26",
"ProductNDC": "45802-937",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089074",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080523",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the molecular formula C21H30O5 and is represented by the following structural formula. Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "45802-952-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE",
"NDC11Code": "45802-0952-26",
"ProductNDC": "45802-952",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20041208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076925",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041228",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use Ibuprofen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: 1 For reduction of fever in patients aged 6 months up to 2 years of age., 2 For relief of mild to moderate pain in patients aged 6 months up to 2 years of age., 3 For relief of signs and symptoms of juvenile arthritis.",
"Description": "The active ingredient in Ibuprofen Oral Suspension USP, 100 mg/5 mL is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74º to 77ºC. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H1802 and it has the following structural formula. Ibuprofen Oral Suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum."
},
{
"NDCCode": "45802-968-26",
"PackageDescription": "120 mL in 1 BOTTLE (45802-968-26)",
"NDC11Code": "45802-0968-26",
"ProductNDC": "45802-968",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Griseofulvin",
"NonProprietaryName": "Griseofulvin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20080716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065200",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "45802-974-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-974-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "45802-0974-26",
"ProductNDC": "45802-974",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20080415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090254",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080415",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "21695-961-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-961-30)",
"NDC11Code": "21695-0961-30",
"ProductNDC": "21695-961",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110610",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride tablets (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of venlafaxine hydrochloride extended-release capsules in hospitalized depressed patients have not been adequately studied. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride extended-release tablets (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Venlafaxine hydrochloride extended-release capsules for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine hydrochloride extended-release capsules are formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "67502-961-04",
"PackageDescription": "750 mL in 1 BOTTLE, PLASTIC (67502-961-04) ",
"NDC11Code": "67502-0961-04",
"ProductNDC": "67502-961",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moisturizing Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Intercon Chemical Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2023-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20151001",
"SamplePackage": "N"
},
{
"NDCCode": "45802-118-46",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-118-46) / 60 mL in 1 BOTTLE",
"NDC11Code": "45802-0118-46",
"ProductNDC": "45802-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077180",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081211",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.",
"Description": "Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate 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 empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5."
},
{
"NDCCode": "45802-118-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-118-59) / 30 mL in 1 BOTTLE",
"NDC11Code": "45802-0118-59",
"ProductNDC": "45802-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077180",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090202",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.",
"Description": "Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate 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 empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5."
},
{
"NDCCode": "45802-210-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE",
"NDC11Code": "45802-0210-01",
"ProductNDC": "45802-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin Lingual",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091496",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130920",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is. CH2–ONO2. |. CH–ONO2. |. CH2–ONO2. Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil."
},
{
"NDCCode": "45802-210-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLE",
"NDC11Code": "45802-0210-02",
"ProductNDC": "45802-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin Lingual",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20130920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091496",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130920",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is. CH2–ONO2. |. CH–ONO2. |. CH2–ONO2. Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil."
},
{
"NDCCode": "45802-283-06",
"PackageDescription": "118 mL in 1 BOTTLE (45802-283-06)",
"NDC11Code": "45802-0283-06",
"ProductNDC": "45802-283",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110207",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "45802-327-82",
"PackageDescription": "177 mL in 1 BOTTLE, SPRAY (45802-327-82)",
"NDC11Code": "45802-0327-82",
"ProductNDC": "45802-327",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phenol",
"NonProprietaryName": "Phenol",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20101209",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "PHENOL",
"StrengthNumber": "1.4",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "45802-354-10",
"PackageDescription": "1 TUBE in 1 CARTON (45802-354-10) > 57 g in 1 TUBE",
"NDC11Code": "45802-0354-10",
"ProductNDC": "45802-354",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoidal",
"NonProprietaryName": "Mineral Oil, Petrolatum, Phenylephrine Hcl, Shark Liver Oil",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101004",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL",
"StrengthNumber": "14; 71.9; .25; 3",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-10-26"
},
{
"NDCCode": "45802-390-00",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE",
"NDC11Code": "45802-0390-00",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-390-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE",
"NDC11Code": "45802-0390-01",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-390-02",
"PackageDescription": "1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE",
"NDC11Code": "45802-0390-02",
"ProductNDC": "45802-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "45802-440-75",
"PackageDescription": "1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE",
"NDC11Code": "45802-0440-75",
"ProductNDC": "45802-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penciclovir",
"NonProprietaryName": "Penciclovir",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212368",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "PENCICLOVIR",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.",
"Description": "Penciclovir Cream, 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir Cream, 1% is available for topical administration as a 1% white cream. Each gram of Penciclovir Cream, 1% contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Figure 1: Structural Formula of Penciclovir. penciclovir. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62)."
}
]
}
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<NDCCode>45802-961-26</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (45802-961-26) </PackageDescription>
<NDC11Code>45802-0961-26</NDC11Code>
<ProductNDC>45802-961</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090974</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clobetasol Propionate Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula. Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water. Each gram of Clobetasol Propionate Shampoo, 0.05% contains 0.5 mg of clobetasol propionate in a translucent, colorless viscous liquid shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.</Description>
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<NDC>
<NDCCode>45802-133-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-133-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0133-26</NDC11Code>
<ProductNDC>45802-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
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<PackageDescription>1 BOTTLE in 1 CARTON (45802-140-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0140-26</NDC11Code>
<ProductNDC>45802-140</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-201-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-201-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0201-26</NDC11Code>
<ProductNDC>45802-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:the common coldfluheadachesore throattoothache.</IndicationAndUsage>
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<NDC>
<NDCCode>45802-203-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-203-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0203-26</NDC11Code>
<ProductNDC>45802-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140409</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to:the common coldfluheadachesore throattoothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-419-26</NDCCode>
<PackageDescription>400 g in 1 BOTTLE, PLASTIC (45802-419-26) </PackageDescription>
<NDC11Code>45802-0419-26</NDC11Code>
<ProductNDC>45802-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075570</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.</IndicationAndUsage>
<Description>*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It also contains cetyl alcohol, fragrance, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>45802-485-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-485-26) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0485-26</NDC11Code>
<ProductNDC>45802-485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202848</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11, 21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes.</Description>
</NDC>
<NDC>
<NDCCode>45802-493-26</NDCCode>
<PackageDescription>385 g in 1 BOTTLE, PUMP (45802-493-26) </PackageDescription>
<NDC11Code>45802-0493-26</NDC11Code>
<ProductNDC>45802-493</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075774</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.</IndicationAndUsage>
<Description>*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>45802-626-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0626-26</NDC11Code>
<ProductNDC>45802-626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078398</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) - [2- [4- [ (4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with an empirical formula of C21H25ClN2O32HCl. The molecular weight is 461.82 and the chemical structure is shown below. Cetirizine hydrochloride is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the solution are: banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, sodium acetate anhydrous, sucrose, and water.</Description>
</NDC>
<NDC>
<NDCCode>45802-887-26</NDCCode>
<PackageDescription>118.28 mL in 1 BOTTLE (45802-887-26) </PackageDescription>
<NDC11Code>45802-0887-26</NDC11Code>
<ProductNDC>45802-887</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202847</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil is indicated for the topical treatment of: 1 atopic dermatitis in adults , 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Fluocinolone acetonide topical oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide topical oil is heated just below 232°C (450°F) for at least 15 minutes.</Description>
</NDC>
<NDC>
<NDCCode>45802-896-26</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (45802-896-26) </PackageDescription>
<NDC11Code>45802-0896-26</NDC11Code>
<ProductNDC>45802-896</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfacetamide Sodium</ProprietaryName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078649</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) is indicated in the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Each mL of Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion) contains 100 mg of sulfacetamide sodium in a vehicle consisting of diethanolamine; EDTA; hydroxyethyl cellulose; lauramide DEA; methylparaben; polyethylene glycol 400, monolaurate; propylene glycol; purified water; simethicone; sodium chloride; sodium metabisulfite and xanthan gum. Sulfacetamide sodium is a sulfonamide with antibacterial activity. Chemically, sulfacetamide sodium is N'-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>45802-897-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-897-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0897-26</NDC11Code>
<ProductNDC>45802-897</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45802-913-26</NDCCode>
<PackageDescription>113 g in 1 BOTTLE (45802-913-26)</PackageDescription>
<NDC11Code>45802-0913-26</NDC11Code>
<ProductNDC>45802-913</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
<ProprietaryNameSuffix>Wash</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-937-26</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (45802-937-26) </PackageDescription>
<NDC11Code>45802-0937-26</NDC11Code>
<ProductNDC>45802-937</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089074</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone, USP in a vehicle consisting of carbomer homopolymer type C, ceteareth-20, cetyl alcohol, dehydroacetic acid, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl palmitate, lactic acid, light mineral oil, myristyl alcohol, myristyl lactate, PEG-100 stearate, purified water, sodium hydroxide, sodium PCA, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-, (11ß)-] with the molecular formula C21H30O5 and is represented by the following structural formula. Its molecular weight is 362.46 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>45802-952-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0952-26</NDC11Code>
<ProductNDC>45802-952</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076925</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use Ibuprofen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). In Pediatric Patients, Ibuprofen Oral Suspension is indicated: 1 For reduction of fever in patients aged 6 months up to 2 years of age., 2 For relief of mild to moderate pain in patients aged 6 months up to 2 years of age., 3 For relief of signs and symptoms of juvenile arthritis.</IndicationAndUsage>
<Description>The active ingredient in Ibuprofen Oral Suspension USP, 100 mg/5 mL is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74º to 77ºC. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H1802 and it has the following structural formula. Ibuprofen Oral Suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>45802-968-26</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (45802-968-26)</PackageDescription>
<NDC11Code>45802-0968-26</NDC11Code>
<ProductNDC>45802-968</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Griseofulvin</ProprietaryName>
<NonProprietaryName>Griseofulvin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065200</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-974-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-974-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0974-26</NDC11Code>
<ProductNDC>45802-974</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090254</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-961-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-961-30)</PackageDescription>
<NDC11Code>21695-0961-30</NDC11Code>
<ProductNDC>21695-961</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110610</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride tablets (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of venlafaxine hydrochloride extended-release capsules in hospitalized depressed patients have not been adequately studied. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride extended-release tablets (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules for oral administration contain venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine hydrochloride extended-release capsules are formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67502-961-04</NDCCode>
<PackageDescription>750 mL in 1 BOTTLE, PLASTIC (67502-961-04) </PackageDescription>
<NDC11Code>67502-0961-04</NDC11Code>
<ProductNDC>67502-961</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moisturizing Antibacterial</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Intercon Chemical Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>45802-118-46</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-118-46) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0118-46</NDC11Code>
<ProductNDC>45802-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077180</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate 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 empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5.</Description>
</NDC>
<NDC>
<NDCCode>45802-118-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-118-59) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0118-59</NDC11Code>
<ProductNDC>45802-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077180</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone Furoate Topical Solution 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Topical Solution USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate 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 empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula. Mometasone furoate is a white to off-white powder insoluble in water, freely soluble in acetone and in methylene chloride and sparingly soluble in heptane. Each gram of Mometasone Furoate Topical Solution USP, 0.1% contains 1 mg mometasone furoate in a colorless, clear to translucent solution base of isopropyl alcohol (40%), hexylene glycol, hydroxypropyl cellulose, sodium phosphate monobasic anhydrous, purified water, glycerin and oleic acid. May also contain phosphoric acid used to adjust the pH to approximately 4.5.</Description>
</NDC>
<NDC>
<NDCCode>45802-210-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-210-01) / 60 SPRAY in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0210-01</NDC11Code>
<ProductNDC>45802-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin Lingual</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091496</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is. CH2–ONO2. |. CH–ONO2. |. CH2–ONO2. Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil.</Description>
</NDC>
<NDC>
<NDCCode>45802-210-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (45802-210-02) / 200 SPRAY in 1 BOTTLE</PackageDescription>
<NDC11Code>45802-0210-02</NDC11Code>
<ProductNDC>45802-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin Lingual</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091496</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is. CH2–ONO2. |. CH–ONO2. |. CH2–ONO2. Nitroglycerin Lingual Spray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil.</Description>
</NDC>
<NDC>
<NDCCode>45802-283-06</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (45802-283-06)</PackageDescription>
<NDC11Code>45802-0283-06</NDC11Code>
<ProductNDC>45802-283</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110207</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-327-82</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE, SPRAY (45802-327-82)</PackageDescription>
<NDC11Code>45802-0327-82</NDC11Code>
<ProductNDC>45802-327</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phenol</ProprietaryName>
<NonProprietaryName>Phenol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>PHENOL</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-354-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-354-10) > 57 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0354-10</NDC11Code>
<ProductNDC>45802-354</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoidal</ProprietaryName>
<NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl, Shark Liver Oil</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Perrigo New York Inc</LabelerName>
<SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL</SubstanceName>
<StrengthNumber>14; 71.9; .25; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>45802-390-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-00</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-390-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-01</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-390-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0390-02</NDC11Code>
<ProductNDC>45802-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>45802-440-75</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0440-75</NDC11Code>
<ProductNDC>45802-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penciclovir</ProprietaryName>
<NonProprietaryName>Penciclovir</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212368</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>PENCICLOVIR</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older.</IndicationAndUsage>
<Description>Penciclovir Cream, 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir Cream, 1% is available for topical administration as a 1% white cream. Each gram of Penciclovir Cream, 1% contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure. Figure 1: Structural Formula of Penciclovir. penciclovir. Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62).</Description>
</NDC>
</NDCList>