clobetasol propionate

Generic: clobetasol propionate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-925
Product ID 45802-925_596d1122-15bb-4b30-b175-457ba7933a6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075027
Listing Expiration 2026-12-31
Marketing Start 2008-07-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802925
Hyphenated Format 45802-925

Supplemental Identifiers

RxCUI
861434
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 ANDA075027 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-925-14) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-925-94) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBE
source: ndc

Packages (3)

45802-925-14 1 TUBE in 1 CARTON (45802-925-14) / 15 g in 1 TUBE 45802-925-94 1 TUBE in 1 CARTON (45802-925-94) / 30 g in 1 TUBE 45802-925-96 1 TUBE in 1 CARTON (45802-925-96) / 60 g in 1 TUBE

Ingredients (1)

clobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Clobetasol Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "596d1122-15bb-4b30-b175-457ba7933a6e", "openfda": {"unii": ["779619577M"], "rxcui": ["861434"], "spl_set_id": ["f9df643a-015d-4101-ac8f-c1e05b052df5"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-925-14)  / 15 g in 1 TUBE", "package_ndc": "45802-925-14", "marketing_start_date": "20080730"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-925-94)  / 30 g in 1 TUBE", "package_ndc": "45802-925-94", "marketing_start_date": "20081111"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-925-96)  / 60 g in 1 TUBE", "package_ndc": "45802-925-96", "marketing_start_date": "20080731"}], "brand_name": "Clobetasol Propionate", "product_id": "45802-925_596d1122-15bb-4b30-b175-457ba7933a6e", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-925", "generic_name": "Clobetasol propionate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA075027", "marketing_category": "ANDA", "marketing_start_date": "20080730", "listing_expiration_date": "20261231"}