clobetasol propionate

Generic: clobetasol propionate

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler xiromed, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clobetasol propionate .5 mg/g

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-109
Product ID 70700-109_3c32f122-0b2c-5c00-e063-6294a90a0a95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210034
Listing Expiration 2026-12-31
Marketing Start 2018-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700109
Hyphenated Format 70700-109

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 ANDA210034 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (70700-109-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (70700-109-16) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (70700-109-17) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (70700-109-18) / 45 g in 1 TUBE
source: ndc

Packages (4)

70700-109-15 1 TUBE in 1 CARTON (70700-109-15) / 15 g in 1 TUBE 70700-109-16 1 TUBE in 1 CARTON (70700-109-16) / 30 g in 1 TUBE 70700-109-17 1 TUBE in 1 CARTON (70700-109-17) / 60 g in 1 TUBE 70700-109-18 1 TUBE in 1 CARTON (70700-109-18) / 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": "3c32f122-0b2c-5c00-e063-6294a90a0a95", "openfda": {"unii": ["779619577M"], "rxcui": ["861495"], "spl_set_id": ["2556987f-4b0f-8a83-5bf4-095d67a450b4"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70700-109-15)  / 15 g in 1 TUBE", "package_ndc": "70700-109-15", "marketing_start_date": "20180619"}, {"sample": false, "description": "1 TUBE in 1 CARTON (70700-109-16)  / 30 g in 1 TUBE", "package_ndc": "70700-109-16", "marketing_start_date": "20180619"}, {"sample": false, "description": "1 TUBE in 1 CARTON (70700-109-17)  / 60 g in 1 TUBE", "package_ndc": "70700-109-17", "marketing_start_date": "20180619"}, {"sample": false, "description": "1 TUBE in 1 CARTON (70700-109-18)  / 45 g in 1 TUBE", "package_ndc": "70700-109-18", "marketing_start_date": "20180619"}], "brand_name": "Clobetasol Propionate", "product_id": "70700-109_3c32f122-0b2c-5c00-e063-6294a90a0a95", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70700-109", "generic_name": "Clobetasol Propionate", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clobetasol Propionate", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA210034", "marketing_category": "ANDA", "marketing_start_date": "20180619", "listing_expiration_date": "20261231"}