halobetasol propionate

Generic: halobetasol propionate

Labeler: mayne pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name halobetasol propionate
Generic Name halobetasol propionate
Labeler mayne pharma
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

halobetasol propionate .5 mg/g

Manufacturer
Mayne Pharma

Identifiers & Regulatory

Product NDC 68308-769
Product ID 68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215266
Listing Expiration 2026-12-31
Marketing Start 2023-11-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308769
Hyphenated Format 68308-769

Supplemental Identifiers

RxCUI
2047646
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 ANDA215266 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER
source: ndc

Packages (1)

68308-769-50 1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTER

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": "096144f6-b603-41a6-b2a6-760e3a5c43c5", "openfda": {"unii": ["91A0K1TY3Z"], "rxcui": ["2047646"], "spl_set_id": ["24c41e6d-a314-4984-b45f-e5aa1fffa9b6"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CANISTER in 1 CARTON (68308-769-50)  / 50 g in 1 CANISTER", "package_ndc": "68308-769-50", "marketing_start_date": "20231201"}], "brand_name": "Halobetasol propionate", "product_id": "68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68308-769", "generic_name": "Halobetasol propionate", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Halobetasol propionate", "active_ingredients": [{"name": "HALOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA215266", "marketing_category": "ANDA", "marketing_start_date": "20231127", "listing_expiration_date": "20261231"}