clotrimazole

Generic: clotrimazole

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG NDA 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 2 g/100g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2062
Product ID 51672-2062_38f45393-2a05-113d-e063-6294a90a79e2
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021143
Listing Expiration 2026-12-31
Marketing Start 2000-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516722062
Hyphenated Format 51672-2062

Supplemental Identifiers

RxCUI
199603
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 NDA021143 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2062-0) / 21 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

51672-2062-0 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2062-0) / 21 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

clotrimazole (2 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": "38f45393-2a05-113d-e063-6294a90a79e2", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["199603"], "spl_set_id": ["325a40b0-3e17-47c6-8988-d5396ca5d53f"], "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, WITH APPLICATOR in 1 CARTON (51672-2062-0)  / 21 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "51672-2062-0", "marketing_start_date": "20000412"}], "brand_name": "Clotrimazole", "product_id": "51672-2062_38f45393-2a05-113d-e063-6294a90a79e2", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-2062", "generic_name": "Clotrimazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "2 g/100g"}], "application_number": "NDA021143", "marketing_category": "NDA", "marketing_start_date": "20000412", "listing_expiration_date": "20261231"}