clobetasol propionate

Generic: clobetasol propionate

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

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler torrent pharmaceuticals limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-569
Product ID 13668-569_440f38d7-45f3-4677-b818-82971ab28fb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211836
Listing Expiration 2026-12-31
Marketing Start 2024-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668569
Hyphenated Format 13668-569

Supplemental Identifiers

RxCUI
861495
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 ANDA211836 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (13668-569-01)
  • 30 g in 1 TUBE (13668-569-02)
  • 45 g in 1 TUBE (13668-569-04)
  • 60 g in 1 TUBE (13668-569-05)
source: ndc

Packages (4)

13668-569-01 15 g in 1 TUBE (13668-569-01) 13668-569-02 30 g in 1 TUBE (13668-569-02) 13668-569-04 45 g in 1 TUBE (13668-569-04) 13668-569-05 60 g in 1 TUBE (13668-569-05)

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": "440f38d7-45f3-4677-b818-82971ab28fb0", "openfda": {"unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["6f930298-e410-4bfb-8c3f-456a1f55f4a9"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (13668-569-01)", "package_ndc": "13668-569-01", "marketing_start_date": "20241215"}, {"sample": false, "description": "30 g in 1 TUBE (13668-569-02)", "package_ndc": "13668-569-02", "marketing_start_date": "20241215"}, {"sample": false, "description": "45 g in 1 TUBE (13668-569-04)", "package_ndc": "13668-569-04", "marketing_start_date": "20241215"}, {"sample": false, "description": "60 g in 1 TUBE (13668-569-05)", "package_ndc": "13668-569-05", "marketing_start_date": "20241215"}], "brand_name": "Clobetasol Propionate", "product_id": "13668-569_440f38d7-45f3-4677-b818-82971ab28fb0", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "13668-569", "generic_name": "Clobetasol Propionate", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA211836", "marketing_category": "ANDA", "marketing_start_date": "20241215", "listing_expiration_date": "20261231"}