clobetasol propionate

Generic: clobetasol propionate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler sun pharmaceutical industries, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1350
Product ID 51672-1350_3961f9ed-9667-e4ae-e063-6394a90a279f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200302
Listing Expiration 2026-12-31
Marketing Start 2012-07-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721350
Hyphenated Format 51672-1350

Supplemental Identifiers

RxCUI
861505
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 ANDA200302 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-1350-4) / 59 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-1350-8) / 118 mL in 1 BOTTLE
source: ndc

Packages (2)

51672-1350-4 1 BOTTLE in 1 CARTON (51672-1350-4) / 59 mL in 1 BOTTLE 51672-1350-8 1 BOTTLE in 1 CARTON (51672-1350-8) / 118 mL in 1 BOTTLE

Ingredients (1)

clobetasol propionate (.5 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": "3961f9ed-9667-e4ae-e063-6394a90a279f", "openfda": {"unii": ["779619577M"], "rxcui": ["861505"], "spl_set_id": ["d4c73fb0-9675-4c41-a8bd-dd4cb2db1169"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1350-4)  / 59 mL in 1 BOTTLE", "package_ndc": "51672-1350-4", "marketing_start_date": "20120702"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-1350-8)  / 118 mL in 1 BOTTLE", "package_ndc": "51672-1350-8", "marketing_start_date": "20120702"}], "brand_name": "Clobetasol Propionate", "product_id": "51672-1350_3961f9ed-9667-e4ae-e063-6394a90a279f", "dosage_form": "LOTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "51672-1350", "generic_name": "clobetasol propionate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA200302", "marketing_category": "ANDA", "marketing_start_date": "20120702", "listing_expiration_date": "20261231"}