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

Generic: clobetasol propionate cream usp, 0.05%

Labeler: northstar rx llc
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 northstar rx llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 72603-323
Product ID 72603-323_2a356447-46d2-40cc-b850-f387982c517a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212982
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603323
Hyphenated Format 72603-323

Supplemental Identifiers

RxCUI
861495
UPC
0372603323047 0372603323030
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 (72603-323-01)
  • 30 g in 1 TUBE (72603-323-02)
  • 45 g in 1 TUBE (72603-323-03)
  • 60 g in 1 TUBE (72603-323-04)
source: ndc

Packages (4)

72603-323-01 15 g in 1 TUBE (72603-323-01) 72603-323-02 30 g in 1 TUBE (72603-323-02) 72603-323-03 45 g in 1 TUBE (72603-323-03) 72603-323-04 60 g in 1 TUBE (72603-323-04)

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": "2a356447-46d2-40cc-b850-f387982c517a", "openfda": {"upc": ["0372603323047", "0372603323030"], "unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["2a356447-46d2-40cc-b850-f387982c517a"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (72603-323-01)", "package_ndc": "72603-323-01", "marketing_start_date": "20241101"}, {"sample": false, "description": "30 g in 1 TUBE (72603-323-02)", "package_ndc": "72603-323-02", "marketing_start_date": "20241101"}, {"sample": false, "description": "45 g in 1 TUBE (72603-323-03)", "package_ndc": "72603-323-03", "marketing_start_date": "20241101"}, {"sample": false, "description": "60 g in 1 TUBE (72603-323-04)", "package_ndc": "72603-323-04", "marketing_start_date": "20241101"}], "brand_name": "Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%", "product_id": "72603-323_2a356447-46d2-40cc-b850-f387982c517a", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72603-323", "generic_name": "Clobetasol Propionate Cream USP, 0.05%", "labeler_name": "Northstar Rx LLC", "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": "20241101", "listing_expiration_date": "20261231"}