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 OINTMENT
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-096
Product ID 43386-096_370129be-84f5-4edf-b821-ffbad2db8c66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208841
Listing Expiration 2026-12-31
Marketing Start 2018-06-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386096
Hyphenated Format 43386-096

Supplemental Identifiers

RxCUI
861448
UPC
0343386096633 0343386096626 0343386096619
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 ANDA208841 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (43386-096-60) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43386-096-61) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43386-096-62) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (43386-096-63) / 45 g in 1 TUBE
source: ndc

Packages (4)

43386-096-60 1 TUBE in 1 CARTON (43386-096-60) / 15 g in 1 TUBE 43386-096-61 1 TUBE in 1 CARTON (43386-096-61) / 30 g in 1 TUBE 43386-096-62 1 TUBE in 1 CARTON (43386-096-62) / 60 g in 1 TUBE 43386-096-63 1 TUBE in 1 CARTON (43386-096-63) / 45 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": "370129be-84f5-4edf-b821-ffbad2db8c66", "openfda": {"upc": ["0343386096633", "0343386096626", "0343386096619"], "unii": ["779619577M"], "rxcui": ["861448"], "spl_set_id": ["3e0fe7b1-f511-491f-b74d-3ca00449835b"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (43386-096-60)  / 15 g in 1 TUBE", "package_ndc": "43386-096-60", "marketing_start_date": "20180602"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43386-096-61)  / 30 g in 1 TUBE", "package_ndc": "43386-096-61", "marketing_start_date": "20180602"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43386-096-62)  / 60 g in 1 TUBE", "package_ndc": "43386-096-62", "marketing_start_date": "20180602"}, {"sample": false, "description": "1 TUBE in 1 CARTON (43386-096-63)  / 45 g in 1 TUBE", "package_ndc": "43386-096-63", "marketing_start_date": "20180602"}], "brand_name": "clobetasol propionate", "product_id": "43386-096_370129be-84f5-4edf-b821-ffbad2db8c66", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43386-096", "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/g"}], "application_number": "ANDA208841", "marketing_category": "ANDA", "marketing_start_date": "20180602", "listing_expiration_date": "20261231"}