clobetasol propionate

Generic: clobetasol propionate ointment, 0.05%

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

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate ointment, 0.05%
Labeler preferred pharmaceuticals inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7963
Product ID 68788-7963_2fd794c4-ecb8-4f6b-875a-390ed62f639d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211295
Listing Expiration 2026-12-31
Marketing Start 2021-07-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687887963
Hyphenated Format 68788-7963

Supplemental Identifiers

RxCUI
861448
UNII
779619577M

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 ointment, 0.05% (source: ndc)
Application Number ANDA211295 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-7963-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68788-7963-3) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68788-7963-6) / 60 g in 1 TUBE
source: ndc

Packages (3)

68788-7963-1 1 TUBE in 1 CARTON (68788-7963-1) / 15 g in 1 TUBE 68788-7963-3 1 TUBE in 1 CARTON (68788-7963-3) / 30 g in 1 TUBE 68788-7963-6 1 TUBE in 1 CARTON (68788-7963-6) / 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": "2fd794c4-ecb8-4f6b-875a-390ed62f639d", "openfda": {"unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["087c5aee-d7fd-42ce-b213-14c810292808"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-7963-1)  / 15 g in 1 TUBE", "package_ndc": "68788-7963-1", "marketing_start_date": "20210719"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68788-7963-3)  / 30 g in 1 TUBE", "package_ndc": "68788-7963-3", "marketing_start_date": "20210719"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68788-7963-6)  / 60 g in 1 TUBE", "package_ndc": "68788-7963-6", "marketing_start_date": "20210719"}], "brand_name": "Clobetasol Propionate", "product_id": "68788-7963_2fd794c4-ecb8-4f6b-875a-390ed62f639d", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68788-7963", "generic_name": "Clobetasol Propionate Ointment, 0.05%", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA211295", "marketing_category": "ANDA", "marketing_start_date": "20210719", "listing_expiration_date": "20261231"}