clobetasol propionate

Generic: clobetasol propionate

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

Drug Facts

Product Profile

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

clobetasol propionate .5 mg/mL

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-028
Product ID 43386-028_e54a7d86-dbf1-476b-bd27-a1853d3e74d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206075
Listing Expiration 2026-12-31
Marketing Start 2015-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386028
Hyphenated Format 43386-028

Supplemental Identifiers

RxCUI
861487
UPC
0343386028603 0343386028610
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 ANDA206075 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43386-028-60) / 50 mL in 1 BOTTLE
source: ndc

Packages (1)

43386-028-60 1 BOTTLE in 1 CARTON (43386-028-60) / 50 mL in 1 BOTTLE

Ingredients (1)

clobetasol propionate (.5 mg/mL)

Linked Drug Pages (1)

clobetasol propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e54a7d86-dbf1-476b-bd27-a1853d3e74d7", "openfda": {"upc": ["0343386028603", "0343386028610"], "unii": ["779619577M"], "rxcui": ["861487"], "spl_set_id": ["c6efb5f3-3532-4742-a359-3991bb76338f"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43386-028-60)  / 50 mL in 1 BOTTLE", "package_ndc": "43386-028-60", "marketing_start_date": "20151123"}], "brand_name": "clobetasol propionate", "product_id": "43386-028_e54a7d86-dbf1-476b-bd27-a1853d3e74d7", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43386-028", "generic_name": "clobetasol propionate", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clobetasol propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA206075", "marketing_category": "ANDA", "marketing_start_date": "20151123", "listing_expiration_date": "20261231"}