clotrimazole

Generic: clotrimazole

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler preferred pharmaceuticals inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8491
Product ID 68788-8491_6a675b34-03f8-4571-8c1c-3a9bb8804df4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074165
Listing Expiration 2026-12-31
Marketing Start 2023-07-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888491
Hyphenated Format 68788-8491

Supplemental Identifiers

RxCUI
309368
UNII
G07GZ97H65
NUI
N0000175487 M0002083

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 ANDA074165 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4) / 45 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

68788-8491-4 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4) / 45 g in 1 TUBE, WITH APPLICATOR

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": ["VAGINAL"], "spl_id": "6a675b34-03f8-4571-8c1c-3a9bb8804df4", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309368"], "spl_set_id": ["fd010006-f646-46ed-841a-9f247b19e397"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8491-4)  / 45 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "68788-8491-4", "marketing_start_date": "20230724"}], "brand_name": "Clotrimazole", "product_id": "68788-8491_6a675b34-03f8-4571-8c1c-3a9bb8804df4", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68788-8491", "generic_name": "Clotrimazole", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA074165", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20261231"}