clobetasol propionate

Generic: clobetasol propionate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler macleods pharmaceuticals limited
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clobetasol propionate .4625 mg/mL

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-321
Product ID 33342-321_7b4cca50-7139-4d48-8f4a-f8204fc46b2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209361
Listing Expiration 2026-12-31
Marketing Start 2017-11-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342321
Hyphenated Format 33342-321

Supplemental Identifiers

UPC
0333342321398 0333342321862
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 ANDA209361 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .4625 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (33342-321-39) / 25 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (33342-321-86) / 50 mL in 1 BOTTLE
source: ndc

Packages (2)

33342-321-39 1 BOTTLE in 1 CARTON (33342-321-39) / 25 mL in 1 BOTTLE 33342-321-86 1 BOTTLE in 1 CARTON (33342-321-86) / 50 mL in 1 BOTTLE

Ingredients (1)

clobetasol propionate (.4625 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": "7b4cca50-7139-4d48-8f4a-f8204fc46b2e", "openfda": {"upc": ["0333342321398", "0333342321862"], "unii": ["779619577M"], "spl_set_id": ["5ad9c808-6095-4d86-b140-e0f6d4079a3a"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (33342-321-39)  / 25 mL in 1 BOTTLE", "package_ndc": "33342-321-39", "marketing_start_date": "20211008"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (33342-321-86)  / 50 mL in 1 BOTTLE", "package_ndc": "33342-321-86", "marketing_start_date": "20171104"}], "brand_name": "Clobetasol Propionate", "product_id": "33342-321_7b4cca50-7139-4d48-8f4a-f8204fc46b2e", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "33342-321", "generic_name": "Clobetasol Propionate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".4625 mg/mL"}], "application_number": "ANDA209361", "marketing_category": "ANDA", "marketing_start_date": "20171104", "listing_expiration_date": "20261231"}