econazole nitrate

Generic: econazole nitrate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name econazole nitrate
Generic Name econazole nitrate
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

econazole nitrate 10 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-466
Product ID 45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076479
Listing Expiration 2026-12-31
Marketing Start 2006-08-08

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802466
Hyphenated Format 45802-466

Supplemental Identifiers

RxCUI
857366
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 ANDA076479 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-466-11) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-466-35) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-466-53) / 85 g in 1 TUBE
source: ndc

Packages (3)

45802-466-11 1 TUBE in 1 CARTON (45802-466-11) / 30 g in 1 TUBE 45802-466-35 1 TUBE in 1 CARTON (45802-466-35) / 15 g in 1 TUBE 45802-466-53 1 TUBE in 1 CARTON (45802-466-53) / 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": "a926c9d7-1215-47b9-a0ed-462941c209fc", "openfda": {"unii": ["H438WYN10E"], "rxcui": ["857366"], "spl_set_id": ["3acc5e03-0339-4b23-945d-641746e81923"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-466-11)  / 30 g in 1 TUBE", "package_ndc": "45802-466-11", "marketing_start_date": "20061110"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-466-35)  / 15 g in 1 TUBE", "package_ndc": "45802-466-35", "marketing_start_date": "20061221"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-466-53)  / 85 g in 1 TUBE", "package_ndc": "45802-466-53", "marketing_start_date": "20060808"}], "brand_name": "Econazole Nitrate", "product_id": "45802-466_a926c9d7-1215-47b9-a0ed-462941c209fc", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "45802-466", "generic_name": "Econazole Nitrate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Econazole Nitrate", "active_ingredients": [{"name": "ECONAZOLE NITRATE", "strength": "10 mg/g"}], "application_number": "ANDA076479", "marketing_category": "ANDA", "marketing_start_date": "20060808", "listing_expiration_date": "20261231"}