clobetasol propionate

Generic: clobetasol propionate

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

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler zydus pharmaceuticals usa inc.
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

clobetasol propionate .05 g/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-998
Product ID 68382-998_4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206378
Listing Expiration 2026-12-31
Marketing Start 2017-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382998
Hyphenated Format 68382-998

Supplemental Identifiers

RxCUI
861512
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 ANDA206378 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .05 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68382-998-01) / 59 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68382-998-02) / 125 mL in 1 BOTTLE
source: ndc

Packages (2)

68382-998-01 1 BOTTLE in 1 CARTON (68382-998-01) / 59 mL in 1 BOTTLE 68382-998-02 1 BOTTLE in 1 CARTON (68382-998-02) / 125 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": "4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624", "openfda": {"unii": ["779619577M"], "rxcui": ["861512"], "spl_set_id": ["8618a3bc-5601-4273-a708-27b0ecd4c385"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68382-998-01)  / 59 mL in 1 BOTTLE", "package_ndc": "68382-998-01", "marketing_start_date": "20170712"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68382-998-02)  / 125 mL in 1 BOTTLE", "package_ndc": "68382-998-02", "marketing_start_date": "20170712"}], "brand_name": "clobetasol propionate", "product_id": "68382-998_4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68382-998", "generic_name": "clobetasol propionate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clobetasol propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".05 g/mL"}], "application_number": "ANDA206378", "marketing_category": "ANDA", "marketing_start_date": "20170712", "listing_expiration_date": "20261231"}