clobetasol propionate

Generic: clobetasol propionate

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler encube ethicals, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-061
Product ID 21922-061_77a7c575-4479-4611-9fb0-10744295822d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076977
Listing Expiration 2026-12-31
Marketing Start 2024-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922061
Hyphenated Format 21922-061

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 ANDA076977 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (21922-061-22) / 25 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (21922-061-27) / 50 mL in 1 BOTTLE
source: ndc

Packages (2)

21922-061-22 1 BOTTLE in 1 CARTON (21922-061-22) / 25 mL in 1 BOTTLE 21922-061-27 1 BOTTLE in 1 CARTON (21922-061-27) / 50 mL in 1 BOTTLE

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": "77a7c575-4479-4611-9fb0-10744295822d", "openfda": {"unii": ["779619577M"], "rxcui": ["861487"], "spl_set_id": ["8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-061-22)  / 25 mL in 1 BOTTLE", "package_ndc": "21922-061-22", "marketing_start_date": "20240610"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (21922-061-27)  / 50 mL in 1 BOTTLE", "package_ndc": "21922-061-27", "marketing_start_date": "20240610"}], "brand_name": "CLOBETASOL PROPIONATE", "product_id": "21922-061_77a7c575-4479-4611-9fb0-10744295822d", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-061", "generic_name": "clobetasol propionate", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOBETASOL PROPIONATE", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA076977", "marketing_category": "ANDA", "marketing_start_date": "20240610", "listing_expiration_date": "20261231"}