clobetasol propionate

Generic: clobetasol propionate

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler e. fougera & co. a division of fougera pharmaceuticals inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

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

Identifiers & Regulatory

Product NDC 0168-0162
Product ID 0168-0162_42f6771f-30f7-467e-94da-2334ea31fdab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074407
Listing Expiration 2026-12-31
Marketing Start 1996-02-23

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680162
Hyphenated Format 0168-0162

Supplemental Identifiers

RxCUI
861434 861448 861495
UPC
0301680162157 0301680293158 0301680163154
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 (source: ndc)
Generic Name clobetasol propionate (source: ndc)
Application Number ANDA074407 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (0168-0162-15)
  • 30 g in 1 TUBE (0168-0162-30)
  • 45 g in 1 TUBE (0168-0162-46)
  • 60 g in 1 TUBE (0168-0162-60)
source: ndc

Packages (4)

0168-0162-15 15 g in 1 TUBE (0168-0162-15) 0168-0162-30 30 g in 1 TUBE (0168-0162-30) 0168-0162-46 45 g in 1 TUBE (0168-0162-46) 0168-0162-60 60 g in 1 TUBE (0168-0162-60)

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42f6771f-30f7-467e-94da-2334ea31fdab", "openfda": {"upc": ["0301680162157", "0301680293158", "0301680163154"], "unii": ["779619577M"], "rxcui": ["861434", "861448", "861495"], "spl_set_id": ["2d4fa3a3-dc1c-4d3c-9959-4751e09d25be"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (0168-0162-15)", "package_ndc": "0168-0162-15", "marketing_start_date": "19960223"}, {"sample": false, "description": "30 g in 1 TUBE (0168-0162-30)", "package_ndc": "0168-0162-30", "marketing_start_date": "19960223"}, {"sample": false, "description": "45 g in 1 TUBE (0168-0162-46)", "package_ndc": "0168-0162-46", "marketing_start_date": "19960223"}, {"sample": false, "description": "60 g in 1 TUBE (0168-0162-60)", "package_ndc": "0168-0162-60", "marketing_start_date": "19960223"}], "brand_name": "Clobetasol Propionate", "product_id": "0168-0162_42f6771f-30f7-467e-94da-2334ea31fdab", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0162", "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", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA074407", "marketing_category": "ANDA", "marketing_start_date": "19960223", "listing_expiration_date": "20261231"}