econazole nitrate

Generic: econazole nitrate

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

Drug Facts

Product Profile

Brand Name econazole nitrate
Generic Name econazole nitrate
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

econazole nitrate 10 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1303
Product ID 51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076005
Listing Expiration 2026-12-31
Marketing Start 2002-11-26

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721303
Hyphenated Format 51672-1303

Supplemental Identifiers

RxCUI
857366
UPC
0351672130312
UNII
H438WYN10E

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 econazole nitrate (source: ndc)
Generic Name econazole nitrate (source: ndc)
Application Number ANDA076005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBE
source: ndc

Packages (3)

51672-1303-1 1 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE 51672-1303-2 1 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE 51672-1303-8 1 TUBE in 1 CARTON (51672-1303-8) / 85 g in 1 TUBE

Ingredients (1)

econazole nitrate (10 mg/g)

Linked Drug Pages (1)

Econazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3d47799f-26f4-68d6-e063-6294a90a4ab5", "openfda": {"upc": ["0351672130312"], "unii": ["H438WYN10E"], "rxcui": ["857366"], "spl_set_id": ["90c40d7f-94fa-440c-9815-30378f76ae79"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1303-1)  / 15 g in 1 TUBE", "package_ndc": "51672-1303-1", "marketing_start_date": "20021126"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1303-2)  / 30 g in 1 TUBE", "package_ndc": "51672-1303-2", "marketing_start_date": "20021126"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-1303-8)  / 85 g in 1 TUBE", "package_ndc": "51672-1303-8", "marketing_start_date": "20021126"}], "brand_name": "Econazole Nitrate", "product_id": "51672-1303_3d47799f-26f4-68d6-e063-6294a90a4ab5", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-1303", "generic_name": "Econazole Nitrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Econazole Nitrate", "active_ingredients": [{"name": "ECONAZOLE NITRATE", "strength": "10 mg/g"}], "application_number": "ANDA076005", "marketing_category": "ANDA", "marketing_start_date": "20021126", "listing_expiration_date": "20261231"}