clotrimazole

Generic: clotrimazole

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

Drug Facts

Product Profile

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

clotrimazole 10 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1260
Product ID 51672-1260_390848b9-e9c6-c3c4-e063-6294a90a5b26
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074580
Listing Expiration 2026-12-31
Marketing Start 1996-07-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721260
Hyphenated Format 51672-1260

Supplemental Identifiers

RxCUI
309370
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 ANDA074580 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

51672-1260-3 1 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

clotrimazole (10 mg/mL)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "390848b9-e9c6-c3c4-e063-6294a90a5b26", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["3e2041a0-8bef-4be4-b2b1-556446c4a778"], "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 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "51672-1260-3", "marketing_start_date": "19960729"}], "brand_name": "Clotrimazole", "product_id": "51672-1260_390848b9-e9c6-c3c4-e063-6294a90a5b26", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-1260", "generic_name": "Clotrimazole", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA074580", "marketing_category": "ANDA", "marketing_start_date": "19960729", "listing_expiration_date": "20261231"}