halobetasol propionate

Generic: halobetasol propionate

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

Drug Facts

Product Profile

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

halobetasol propionate .5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0339
Product ID 0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077109
Listing Expiration 2026-12-31
Marketing Start 2005-06-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130339
Hyphenated Format 0713-0339

Supplemental Identifiers

RxCUI
977978
UNII
91A0K1TY3Z

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 halobetasol propionate (source: ndc)
Generic Name halobetasol propionate (source: ndc)
Application Number ANDA077109 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBE
source: ndc

Packages (2)

0713-0339-15 1 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBE 0713-0339-86 1 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBE

Ingredients (1)

halobetasol propionate (.5 mg/g)

Linked Drug Pages (1)

Halobetasol Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "163af771-5ae8-ac38-e063-6294a90ae5bd", "openfda": {"unii": ["91A0K1TY3Z"], "rxcui": ["977978"], "spl_set_id": ["f12ff257-dd77-4f9c-97c4-339784772d9f"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0713-0339-15)  / 15 g in 1 TUBE", "package_ndc": "0713-0339-15", "marketing_start_date": "20180221"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0713-0339-86)  / 50 g in 1 TUBE", "package_ndc": "0713-0339-86", "marketing_start_date": "20180221"}], "brand_name": "Halobetasol Propionate", "product_id": "0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bd", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0713-0339", "generic_name": "Halobetasol Propionate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Halobetasol Propionate", "active_ingredients": [{"name": "HALOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA077109", "marketing_category": "ANDA", "marketing_start_date": "20050614", "listing_expiration_date": "20261231"}