clobetasol propionate (emollient) (0168-0301)

Drug Facts

Product Profile

Brand Name clobetasol propionate (emollient)

Generic Name clobetasol propionate

Labeler e. fougera & co. a division of fougera pharmaceuticals inc.

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0301

Product ID 0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075430

Listing Expiration 2026-12-31

Marketing Start 1999-05-26

Pharmacologic Class

Classes

corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680301

Hyphenated Format 0168-0301

Supplemental Identifiers

RxCUI

1992281

UPC

0301680301150

UNII

779619577M

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clobetasol propionate (emollient) (source: ndc)

Generic Name clobetasol propionate (source: ndc)

Application Number ANDA075430 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.5 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE

source: ndc

Packages (3)

0168-0301-15 1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE 0168-0301-30 1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE 0168-0301-60 1 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate (emollient) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "60e61fbb-1d01-46ee-8a23-c1af3211f23a", "openfda": {"upc": ["0301680301150"], "unii": ["779619577M"], "rxcui": ["1992281"], "spl_set_id": ["fdfd83ee-dfb4-4c12-a74e-a0053e34e08c"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0301-15)  / 15 g in 1 TUBE", "package_ndc": "0168-0301-15", "marketing_start_date": "19990526"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0301-30)  / 30 g in 1 TUBE", "package_ndc": "0168-0301-30", "marketing_start_date": "19990526"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0301-60)  / 60 g in 1 TUBE", "package_ndc": "0168-0301-60", "marketing_start_date": "19990526"}], "brand_name": "Clobetasol Propionate (emollient)", "product_id": "0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0301", "generic_name": "clobetasol propionate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate (emollient)", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA075430", "marketing_category": "ANDA", "marketing_start_date": "19990526", "listing_expiration_date": "20261231"}