clobetasol propionate

Generic: clobetasol propionate

Labeler: glenmark pharmaceutcials inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler glenmark pharmaceutcials inc., usa
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Glenmark Pharmaceutcials Inc., USA

Identifiers & Regulatory

Product NDC 68462-529
Product ID 68462-529_044676e5-96b4-40d4-82db-f87e2abf31a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209095
Listing Expiration 2027-12-31
Marketing Start 2018-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462529
Hyphenated Format 68462-529

Supplemental Identifiers

RxCUI
861495
UPC
0368462529171
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 ANDA209095 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68462-529-17) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-529-35) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-529-47) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (68462-529-65) / 60 g in 1 TUBE
source: ndc

Packages (4)

68462-529-17 1 TUBE in 1 CARTON (68462-529-17) / 15 g in 1 TUBE 68462-529-35 1 TUBE in 1 CARTON (68462-529-35) / 30 g in 1 TUBE 68462-529-47 1 TUBE in 1 CARTON (68462-529-47) / 45 g in 1 TUBE 68462-529-65 1 TUBE in 1 CARTON (68462-529-65) / 60 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": "044676e5-96b4-40d4-82db-f87e2abf31a2", "openfda": {"upc": ["0368462529171"], "unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["69794e0b-2a79-419e-844f-ed051be62249"], "manufacturer_name": ["Glenmark Pharmaceutcials Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68462-529-17)  / 15 g in 1 TUBE", "package_ndc": "68462-529-17", "marketing_start_date": "20180719"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-529-35)  / 30 g in 1 TUBE", "package_ndc": "68462-529-35", "marketing_start_date": "20180510"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-529-47)  / 45 g in 1 TUBE", "package_ndc": "68462-529-47", "marketing_start_date": "20180719"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68462-529-65)  / 60 g in 1 TUBE", "package_ndc": "68462-529-65", "marketing_start_date": "20180510"}], "brand_name": "Clobetasol Propionate", "product_id": "68462-529_044676e5-96b4-40d4-82db-f87e2abf31a2", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68462-529", "generic_name": "Clobetasol Propionate", "labeler_name": "Glenmark Pharmaceutcials Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA209095", "marketing_category": "ANDA", "marketing_start_date": "20180510", "listing_expiration_date": "20271231"}