clobetasol propionate

Generic: clobetasol propionate

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

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler cosette pharmaceuticals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0656
Product ID 0713-0656_0b383db5-a99b-f222-e063-6294a90adc09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074089
Listing Expiration 2026-12-31
Marketing Start 2016-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130656
Hyphenated Format 0713-0656

Supplemental Identifiers

RxCUI
861448
UPC
0307130656313
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 ANDA074089 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0656-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0656-31) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0656-37) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0656-60) / 60 g in 1 TUBE
source: ndc

Packages (4)

0713-0656-15 1 TUBE in 1 CARTON (0713-0656-15) / 15 g in 1 TUBE 0713-0656-31 1 TUBE in 1 CARTON (0713-0656-31) / 30 g in 1 TUBE 0713-0656-37 1 TUBE in 1 CARTON (0713-0656-37) / 45 g in 1 TUBE 0713-0656-60 1 TUBE in 1 CARTON (0713-0656-60) / 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": "0b383db5-a99b-f222-e063-6294a90adc09", "openfda": {"upc": ["0307130656313"], "unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["807d6a1a-4eca-9cf4-f514-bb1cd7b10d0f"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0656-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0656-15", "marketing_start_date": "20160414"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0656-31)  / 30 g in 1 TUBE", "package_ndc": "0713-0656-31", "marketing_start_date": "20160414"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0656-37)  / 45 g in 1 TUBE", "package_ndc": "0713-0656-37", "marketing_start_date": "20160414"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0656-60)  / 60 g in 1 TUBE", "package_ndc": "0713-0656-60", "marketing_start_date": "20160414"}], "brand_name": "Clobetasol Propionate", "product_id": "0713-0656_0b383db5-a99b-f222-e063-6294a90adc09", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0656", "generic_name": "Clobetasol Propionate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA074089", "marketing_category": "ANDA", "marketing_start_date": "20160104", "listing_expiration_date": "20261231"}