clobetasol propionate

Generic: clobetasol propionate

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-532
Product ID 68462-532_8a5a06f3-bb61-4854-8c74-673747cbcfdd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210190
Listing Expiration 2026-12-31
Marketing Start 2018-04-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462532
Hyphenated Format 68462-532

Supplemental Identifiers

RxCUI
861487
UPC
0368462532287
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 ANDA210190 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68462-532-53) / 50 mL in 1 BOTTLE
source: ndc

Packages (2)

68462-532-28 1 BOTTLE in 1 CARTON (68462-532-28) / 25 mL in 1 BOTTLE 68462-532-53 1 BOTTLE in 1 CARTON (68462-532-53) / 50 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": "8a5a06f3-bb61-4854-8c74-673747cbcfdd", "openfda": {"upc": ["0368462532287"], "unii": ["779619577M"], "rxcui": ["861487"], "spl_set_id": ["e37dd885-889a-4bfd-9813-bb7b9b96cee1"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68462-532-28)  / 25 mL in 1 BOTTLE", "package_ndc": "68462-532-28", "marketing_start_date": "20180418"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68462-532-53)  / 50 mL in 1 BOTTLE", "package_ndc": "68462-532-53", "marketing_start_date": "20180418"}], "brand_name": "CLOBETASOL PROPIONATE", "product_id": "68462-532_8a5a06f3-bb61-4854-8c74-673747cbcfdd", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-532", "generic_name": "CLOBETASOL PROPIONATE", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOBETASOL PROPIONATE", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA210190", "marketing_category": "ANDA", "marketing_start_date": "20180418", "listing_expiration_date": "20261231"}