clobetasol propionate

Generic: clobetasol propionate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler macleods pharmaceuticals limited
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-326
Product ID 33342-326_44ced6ce-fa10-426d-a498-a13b8b34f49a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214345
Listing Expiration 2026-12-31
Marketing Start 2024-12-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342326
Hyphenated Format 33342-326

Supplemental Identifiers

RxCUI
861512
UPC
0333342326881 0333342326874
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 ANDA214345 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (33342-326-87) / 59 mL in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (33342-326-88) / 125 mL in 1 BOTTLE, PUMP
source: ndc

Packages (2)

33342-326-87 1 BOTTLE, PUMP in 1 CARTON (33342-326-87) / 59 mL in 1 BOTTLE, PUMP 33342-326-88 1 BOTTLE, PUMP in 1 CARTON (33342-326-88) / 125 mL in 1 BOTTLE, PUMP

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": "44ced6ce-fa10-426d-a498-a13b8b34f49a", "openfda": {"upc": ["0333342326881", "0333342326874"], "unii": ["779619577M"], "rxcui": ["861512"], "spl_set_id": ["44ced6ce-fa10-426d-a498-a13b8b34f49a"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (33342-326-87)  / 59 mL in 1 BOTTLE, PUMP", "package_ndc": "33342-326-87", "marketing_start_date": "20241203"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (33342-326-88)  / 125 mL in 1 BOTTLE, PUMP", "package_ndc": "33342-326-88", "marketing_start_date": "20241203"}], "brand_name": "Clobetasol Propionate", "product_id": "33342-326_44ced6ce-fa10-426d-a498-a13b8b34f49a", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "33342-326", "generic_name": "Clobetasol Propionate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "ANDA214345", "marketing_category": "ANDA", "marketing_start_date": "20241203", "listing_expiration_date": "20261231"}