clobetasol propionate

Generic: clobetasol propionate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler avkare
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-077
Product ID 42291-077_ff958b19-2ce4-442a-e053-6294a90a66a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209701
Listing Expiration 2026-12-31
Marketing Start 2020-06-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291077
Hyphenated Format 42291-077

Supplemental Identifiers

RxCUI
861448
UPC
0348897077300
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 ANDA209701 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (42291-077-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (42291-077-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (42291-077-45) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (42291-077-60) / 60 g in 1 TUBE
source: ndc

Packages (4)

42291-077-15 1 TUBE in 1 CARTON (42291-077-15) / 15 g in 1 TUBE 42291-077-30 1 TUBE in 1 CARTON (42291-077-30) / 30 g in 1 TUBE 42291-077-45 1 TUBE in 1 CARTON (42291-077-45) / 45 g in 1 TUBE 42291-077-60 1 TUBE in 1 CARTON (42291-077-60) / 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": "ff958b19-2ce4-442a-e053-6294a90a66a0", "openfda": {"upc": ["0348897077300"], "unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["a862de41-1500-9136-e053-2a95a90a6080"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (42291-077-15)  / 15 g in 1 TUBE", "package_ndc": "42291-077-15", "marketing_start_date": "20200618"}, {"sample": false, "description": "1 TUBE in 1 CARTON (42291-077-30)  / 30 g in 1 TUBE", "package_ndc": "42291-077-30", "marketing_start_date": "20200618"}, {"sample": false, "description": "1 TUBE in 1 CARTON (42291-077-45)  / 45 g in 1 TUBE", "package_ndc": "42291-077-45", "marketing_start_date": "20200618"}, {"sample": false, "description": "1 TUBE in 1 CARTON (42291-077-60)  / 60 g in 1 TUBE", "package_ndc": "42291-077-60", "marketing_start_date": "20200618"}], "brand_name": "Clobetasol Propionate", "product_id": "42291-077_ff958b19-2ce4-442a-e053-6294a90a66a0", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "42291-077", "generic_name": "clobetasol propionate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA209701", "marketing_category": "ANDA", "marketing_start_date": "20200618", "listing_expiration_date": "20261231"}