clobetasol propionate

Generic: clobetasol propionate

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler mayne pharma inc.
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

clobetasol propionate .05 g/100mL

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 68308-664
Product ID 68308-664_677660bb-7f93-465a-b924-4e477acb4362
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021644
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308664
Hyphenated Format 68308-664

Supplemental Identifiers

RxCUI
861490
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 NDA021644 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .05 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68308-664-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

68308-664-04 1 BOTTLE in 1 CARTON (68308-664-04) / 118 mL in 1 BOTTLE

Ingredients (1)

clobetasol propionate (.05 g/100mL)

Linked Drug Pages (1)

clobetasol propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "677660bb-7f93-465a-b924-4e477acb4362", "openfda": {"unii": ["779619577M"], "rxcui": ["861490"], "spl_set_id": ["524397b3-84c4-49d7-af5e-bb229dfee68b"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68308-664-04)  / 118 mL in 1 BOTTLE", "package_ndc": "68308-664-04", "marketing_start_date": "20231103"}], "brand_name": "clobetasol propionate", "product_id": "68308-664_677660bb-7f93-465a-b924-4e477acb4362", "dosage_form": "SHAMPOO", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68308-664", "generic_name": "clobetasol propionate", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clobetasol propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".05 g/100mL"}], "application_number": "NDA021644", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}