alclometasone dipropionate

Generic: alclometasone dipropionate

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alclometasone dipropionate
Generic Name alclometasone dipropionate
Labeler e. fougera & co. a division of fougera pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

alclometasone dipropionate .5 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0263
Product ID 0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076973
Listing Expiration 2026-12-31
Marketing Start 2005-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680263
Hyphenated Format 0168-0263

Supplemental Identifiers

RxCUI
855474
UPC
0301680263151
UNII
S56PQL4N1V

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 alclometasone dipropionate (source: ndc)
Generic Name alclometasone dipropionate (source: ndc)
Application Number ANDA076973 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (0168-0263-15)
  • 45 g in 1 TUBE (0168-0263-45)
  • 60 g in 1 TUBE (0168-0263-60)
source: ndc

Packages (3)

0168-0263-15 15 g in 1 TUBE (0168-0263-15) 0168-0263-45 45 g in 1 TUBE (0168-0263-45) 0168-0263-60 60 g in 1 TUBE (0168-0263-60)

Ingredients (1)

alclometasone dipropionate (.5 mg/g)

Linked Drug Pages (1)

Alclometasone Dipropionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "901e10b7-2784-49c4-8e56-1c461aaad927", "openfda": {"upc": ["0301680263151"], "unii": ["S56PQL4N1V"], "rxcui": ["855474"], "spl_set_id": ["6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (0168-0263-15)", "package_ndc": "0168-0263-15", "marketing_start_date": "20050712"}, {"sample": false, "description": "45 g in 1 TUBE (0168-0263-45)", "package_ndc": "0168-0263-45", "marketing_start_date": "20050712"}, {"sample": false, "description": "60 g in 1 TUBE (0168-0263-60)", "package_ndc": "0168-0263-60", "marketing_start_date": "20050712"}], "brand_name": "Alclometasone Dipropionate", "product_id": "0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0168-0263", "generic_name": "alclometasone dipropionate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alclometasone Dipropionate", "active_ingredients": [{"name": "ALCLOMETASONE DIPROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA076973", "marketing_category": "ANDA", "marketing_start_date": "20050712", "listing_expiration_date": "20261231"}