clobetasol propionate

Generic: clobetasol propionate

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
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, llc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0269
Product ID 0168-0269_3ae739b7-7eaa-4dbd-a696-a3a0e3998f38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075391
Listing Expiration 2027-12-31
Marketing Start 1999-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680269
Hyphenated Format 0168-0269

Supplemental Identifiers

RxCUI
861487
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 ANDA075391 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)
source: ndc

Packages (1)

0168-0269-50 50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)

Ingredients (1)

clobetasol propionate (.5 mg/mL)

Linked Drug Pages (1)

Clobetasol Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3ae739b7-7eaa-4dbd-a696-a3a0e3998f38", "openfda": {"unii": ["779619577M"], "rxcui": ["861487"], "spl_set_id": ["736325f3-a369-4d70-b608-3d6ba37b6a6b"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)", "package_ndc": "0168-0269-50", "marketing_start_date": "19990208"}], "brand_name": "Clobetasol Propionate", "product_id": "0168-0269_3ae739b7-7eaa-4dbd-a696-a3a0e3998f38", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0269", "generic_name": "Clobetasol Propionate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA075391", "marketing_category": "ANDA", "marketing_start_date": "19990208", "listing_expiration_date": "20271231"}