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 SPRAY
Routes
TOPICAL
Active Ingredients

clobetasol propionate .05 g/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-425
Product ID 46708-425_012b555d-9cbe-4db4-87f7-2b6500eb452e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211191
Listing Expiration 2026-12-31
Marketing Start 2025-02-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708425
Hyphenated Format 46708-425

Supplemental Identifiers

RxCUI
861512
UPC
0346708425593 0346708425128
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 ANDA211191 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .05 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-425-12) / 125 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-425-59) / 59 mL in 1 BOTTLE
source: ndc

Packages (2)

46708-425-12 1 BOTTLE in 1 CARTON (46708-425-12) / 125 mL in 1 BOTTLE 46708-425-59 1 BOTTLE in 1 CARTON (46708-425-59) / 59 mL in 1 BOTTLE

Ingredients (1)

clobetasol propionate (.05 g/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": "012b555d-9cbe-4db4-87f7-2b6500eb452e", "openfda": {"upc": ["0346708425593", "0346708425128"], "unii": ["779619577M"], "rxcui": ["861512"], "spl_set_id": ["96f20fcd-aa96-4472-807b-43094befc8a9"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-425-12)  / 125 mL in 1 BOTTLE", "package_ndc": "46708-425-12", "marketing_start_date": "20250212"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-425-59)  / 59 mL in 1 BOTTLE", "package_ndc": "46708-425-59", "marketing_start_date": "20250212"}], "brand_name": "CLOBETASOL PROPIONATE", "product_id": "46708-425_012b555d-9cbe-4db4-87f7-2b6500eb452e", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-425", "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": ".05 g/mL"}], "application_number": "ANDA211191", "marketing_category": "ANDA", "marketing_start_date": "20250212", "listing_expiration_date": "20261231"}