clobetasol propionate anda

Generic: clobetasol propionate

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

Drug Facts

Product Profile

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

clobetasol propionate .5 mg/g

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-506
Product ID 33342-506_92cf4231-e301-4353-98d9-85206ec6ba96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215990
Listing Expiration 2026-12-31
Marketing Start 2023-12-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342506
Hyphenated Format 33342-506

Supplemental Identifiers

RxCUI
861448
UPC
0333342506603 0333342506306
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 anda (source: ndc)
Generic Name clobetasol propionate (source: ndc)
Application Number ANDA215990 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBE
source: ndc

Packages (4)

33342-506-15 1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE 33342-506-30 1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE 33342-506-45 1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBE 33342-506-60 1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBE

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate ANDA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "92cf4231-e301-4353-98d9-85206ec6ba96", "openfda": {"upc": ["0333342506603", "0333342506306"], "unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["92cf4231-e301-4353-98d9-85206ec6ba96"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (33342-506-15)  / 15 g in 1 TUBE", "package_ndc": "33342-506-15", "marketing_start_date": "20231228"}, {"sample": false, "description": "1 TUBE in 1 CARTON (33342-506-30)  / 30 g in 1 TUBE", "package_ndc": "33342-506-30", "marketing_start_date": "20231228"}, {"sample": false, "description": "1 TUBE in 1 CARTON (33342-506-45)  / 45 g in 1 TUBE", "package_ndc": "33342-506-45", "marketing_start_date": "20231228"}, {"sample": false, "description": "1 TUBE in 1 CARTON (33342-506-60)  / 60 g in 1 TUBE", "package_ndc": "33342-506-60", "marketing_start_date": "20231228"}], "brand_name": "Clobetasol Propionate ANDA", "product_id": "33342-506_92cf4231-e301-4353-98d9-85206ec6ba96", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "33342-506", "generic_name": "Clobetasol Propionate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "brand_name_suffix": "ANDA", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA215990", "marketing_category": "ANDA", "marketing_start_date": "20231228", "listing_expiration_date": "20261231"}