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

Generic: clobetasol propionate cream usp, 0.05%

Labeler: remedyrepack 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 remedyrepack inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4374
Product ID 70518-4374_4031ce86-d4f7-7ea5-e063-6394a90a0d5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212982
Listing Expiration 2026-12-31
Marketing Start 2025-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184374
Hyphenated Format 70518-4374

Supplemental Identifiers

RxCUI
861495
UNII
779619577M

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
  • 30 g in 1 TUBE (70518-4374-0)
source: ndc

Packages (1)

70518-4374-0 30 g in 1 TUBE (70518-4374-0)

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": "4031ce86-d4f7-7ea5-e063-6394a90a0d5a", "openfda": {"unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["61f63eec-ecf3-4979-adab-f26eb8f29d65"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (70518-4374-0)", "package_ndc": "70518-4374-0", "marketing_start_date": "20250627"}], "brand_name": "Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%", "product_id": "70518-4374_4031ce86-d4f7-7ea5-e063-6394a90a0d5a", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70518-4374", "generic_name": "Clobetasol Propionate Cream USP, 0.05%", "labeler_name": "REMEDYREPACK 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": "20250627", "listing_expiration_date": "20261231"}