clotrimazole

Generic: clotrimazole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clotrimazole 1 g/100g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2003
Product ID 51672-2003_376636ca-82fd-cf77-e063-6394a90a669d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA072641
Listing Expiration 2026-12-31
Marketing Start 1995-12-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516722003
Hyphenated Format 51672-2003

Supplemental Identifiers

RxCUI
309368
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 ANDA072641 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE
source: ndc

Packages (1)

51672-2003-6 1 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE

Ingredients (1)

clotrimazole (1 g/100g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "376636ca-82fd-cf77-e063-6394a90a669d", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309368"], "spl_set_id": ["f7192955-8f8c-45dd-a215-8ac2c1f6444f"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-2003-6)  / 45 g in 1 TUBE", "package_ndc": "51672-2003-6", "marketing_start_date": "19951204"}], "brand_name": "Clotrimazole", "product_id": "51672-2003_376636ca-82fd-cf77-e063-6394a90a669d", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-2003", "generic_name": "Clotrimazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/100g"}], "application_number": "ANDA072641", "marketing_category": "ANDA", "marketing_start_date": "19951204", "listing_expiration_date": "20261231"}