halobetasol propionate

Generic: halobetasol propionate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name halobetasol propionate
Generic Name halobetasol propionate
Labeler padagis israel pharmaceuticals ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

halobetasol propionate .5 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-131
Product ID 45802-131_c43eed9c-3fb7-4933-ad26-9d65db4aa474
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076872
Listing Expiration 2026-12-31
Marketing Start 2009-02-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802131
Hyphenated Format 45802-131

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 ANDA076872 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-131-35) / 15 g in 1 TUBE
source: ndc

Packages (2)

45802-131-32 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBE 45802-131-35 1 TUBE in 1 CARTON (45802-131-35) / 15 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": "c43eed9c-3fb7-4933-ad26-9d65db4aa474", "openfda": {"unii": ["91A0K1TY3Z"], "rxcui": ["977978"], "spl_set_id": ["c420da92-a3e3-4760-8cad-e50cbacebfeb"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-131-32)  / 50 g in 1 TUBE", "package_ndc": "45802-131-32", "marketing_start_date": "20090205"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-131-35)  / 15 g in 1 TUBE", "package_ndc": "45802-131-35", "marketing_start_date": "20100114"}], "brand_name": "Halobetasol Propionate", "product_id": "45802-131_c43eed9c-3fb7-4933-ad26-9d65db4aa474", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "45802-131", "generic_name": "Halobetasol Propionate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Halobetasol Propionate", "active_ingredients": [{"name": "HALOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA076872", "marketing_category": "ANDA", "marketing_start_date": "20090205", "listing_expiration_date": "20261231"}