clotrimazole

Generic: clotrimazole

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

Drug Facts

Product Profile

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

clotrimazole 10 mg/g

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

Identifiers & Regulatory

Product NDC 0168-0133
Product ID 0168-0133_a42ebf09-c9f0-47b6-9a36-dcccda087c25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078338
Listing Expiration 2026-12-31
Marketing Start 2008-09-02

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680133
Hyphenated Format 0168-0133

Supplemental Identifiers

RxCUI
309367
UPC
0301680133157
UNII
G07GZ97H65
NUI
N0000175487 M0002083

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 clotrimazole (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number ANDA078338 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 15 g in 1 TUBE (0168-0133-15)
  • 30 g in 1 TUBE (0168-0133-30)
  • 45 g in 1 TUBE (0168-0133-46)
source: ndc

Packages (3)

0168-0133-15 15 g in 1 TUBE (0168-0133-15) 0168-0133-30 30 g in 1 TUBE (0168-0133-30) 0168-0133-46 45 g in 1 TUBE (0168-0133-46)

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a42ebf09-c9f0-47b6-9a36-dcccda087c25", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0301680133157"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["28fdc2c0-fd5f-4d98-a4e1-4702a430086a"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "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 (0168-0133-15)", "package_ndc": "0168-0133-15", "marketing_start_date": "20080902"}, {"sample": false, "description": "30 g in 1 TUBE (0168-0133-30)", "package_ndc": "0168-0133-30", "marketing_start_date": "20080902"}, {"sample": false, "description": "45 g in 1 TUBE (0168-0133-46)", "package_ndc": "0168-0133-46", "marketing_start_date": "20080902"}], "brand_name": "Clotrimazole", "product_id": "0168-0133_a42ebf09-c9f0-47b6-9a36-dcccda087c25", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0168-0133", "generic_name": "clotrimazole", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA078338", "marketing_category": "ANDA", "marketing_start_date": "20080902", "listing_expiration_date": "20261231"}