clotrimazole

Generic: clotrimazole

Labeler: hikma pharmacuticals usa usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler hikma pharmacuticals usa usa inc.
Dosage Form LOZENGE
Routes
ORAL TOPICAL
Active Ingredients

clotrimazole 10 mg/1

Manufacturer
Hikma Pharmacuticals USA USA Inc.

Identifiers & Regulatory

Product NDC 0054-4146
Product ID 0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076387
Listing Expiration 2026-12-31
Marketing Start 2004-07-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00544146
Hyphenated Format 0054-4146

Supplemental Identifiers

RxCUI
309371
UPC
0300544146227
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 ANDA076387 (source: ndc)
Routes
ORAL TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)
  • 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)
source: ndc

Packages (2)

0054-4146-22 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22) 0054-4146-23 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)

Ingredients (1)

clotrimazole (10 mg/1)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "TOPICAL"], "spl_id": "3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0300544146227"], "unii": ["G07GZ97H65"], "rxcui": ["309371"], "spl_set_id": ["0bc4b876-ddee-4f03-b44f-544348739a26"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Hikma Pharmacuticals USA USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)", "package_ndc": "0054-4146-22", "marketing_start_date": "20040729"}, {"sample": false, "description": "140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)", "package_ndc": "0054-4146-23", "marketing_start_date": "20040729"}], "brand_name": "Clotrimazole", "product_id": "0054-4146_3bba6ec1-cfdc-4758-95d1-6aa9ee7ab963", "dosage_form": "LOZENGE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0054-4146", "generic_name": "Clotrimazole", "labeler_name": "Hikma Pharmacuticals USA USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/1"}], "application_number": "ANDA076387", "marketing_category": "ANDA", "marketing_start_date": "20040729", "listing_expiration_date": "20261231"}