clobetasol propionate cream usp, 0.05% clobetasol propionate cream usp, 0.05%

Generic: clobetasol propionate cream usp, 0.05%

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

Drug Facts

Product Profile

Brand Name clobetasol propionate cream usp, 0.05% clobetasol propionate cream usp, 0.05%
Generic Name clobetasol propionate cream usp, 0.05%
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-016
Product ID 21922-016_03d5cd0f-1991-440f-9942-6a140f762b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212982
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922016
Hyphenated Format 21922-016

Supplemental Identifiers

RxCUI
861495
UPC
0321922016055 0321922016062 0321922016079 0321922016048
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 cream usp, 0.05% clobetasol propionate cream usp, 0.05% (source: ndc)
Generic Name clobetasol propionate cream usp, 0.05% (source: ndc)
Application Number ANDA212982 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (21922-016-04)
  • 30 g in 1 TUBE (21922-016-05)
  • 45 g in 1 TUBE (21922-016-06)
  • 60 g in 1 TUBE (21922-016-07)
source: ndc

Packages (4)

21922-016-04 15 g in 1 TUBE (21922-016-04) 21922-016-05 30 g in 1 TUBE (21922-016-05) 21922-016-06 45 g in 1 TUBE (21922-016-06) 21922-016-07 60 g in 1 TUBE (21922-016-07)

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "03d5cd0f-1991-440f-9942-6a140f762b6b", "openfda": {"upc": ["0321922016055", "0321922016062", "0321922016079", "0321922016048"], "unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["bcb76b4b-194d-4cb3-b3ed-26b911df1a11"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (21922-016-04)", "package_ndc": "21922-016-04", "marketing_start_date": "20201001"}, {"sample": false, "description": "30 g in 1 TUBE (21922-016-05)", "package_ndc": "21922-016-05", "marketing_start_date": "20201001"}, {"sample": false, "description": "45 g in 1 TUBE (21922-016-06)", "package_ndc": "21922-016-06", "marketing_start_date": "20201001"}, {"sample": false, "description": "60 g in 1 TUBE (21922-016-07)", "package_ndc": "21922-016-07", "marketing_start_date": "20201001"}], "brand_name": "Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%", "product_id": "21922-016_03d5cd0f-1991-440f-9942-6a140f762b6b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "21922-016", "generic_name": "Clobetasol Propionate Cream USP, 0.05%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate Cream USP, 0.05%", "brand_name_suffix": "Clobetasol Propionate Cream USP, 0.05%", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA212982", "marketing_category": "ANDA", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}