clobetasol propionate

Generic: clobetasol propionate

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

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler alembic pharmaceuticals limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-547
Product ID 46708-547_99341bff-4fc2-4651-9e4f-448a2b9052b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213291
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708547
Hyphenated Format 46708-547

Supplemental Identifiers

RxCUI
861495
UPC
0346708547158
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 ANDA213291 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (46708-547-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-547-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-547-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-547-60) / 60 g in 1 TUBE
source: ndc

Packages (4)

46708-547-15 1 TUBE in 1 CARTON (46708-547-15) / 15 g in 1 TUBE 46708-547-30 1 TUBE in 1 CARTON (46708-547-30) / 30 g in 1 TUBE 46708-547-45 1 TUBE in 1 CARTON (46708-547-45) / 45 g in 1 TUBE 46708-547-60 1 TUBE in 1 CARTON (46708-547-60) / 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": "99341bff-4fc2-4651-9e4f-448a2b9052b2", "openfda": {"upc": ["0346708547158"], "unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["a4f74fc7-d2f6-4cf2-9cc5-60078bde55a7"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-547-15)  / 15 g in 1 TUBE", "package_ndc": "46708-547-15", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-547-30)  / 30 g in 1 TUBE", "package_ndc": "46708-547-30", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-547-45)  / 45 g in 1 TUBE", "package_ndc": "46708-547-45", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-547-60)  / 60 g in 1 TUBE", "package_ndc": "46708-547-60", "marketing_start_date": "20250326"}], "brand_name": "CLOBETASOL PROPIONATE", "product_id": "46708-547_99341bff-4fc2-4651-9e4f-448a2b9052b2", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-547", "generic_name": "CLOBETASOL PROPIONATE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOBETASOL PROPIONATE", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA213291", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}