gynazole 1

Generic: butoconazole nitrate

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

Drug Facts

Product Profile

Brand Name gynazole 1
Generic Name butoconazole nitrate
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

butoconazole nitrate 100 mg/5g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-396
Product ID 45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200923
Listing Expiration 2026-12-31
Marketing Start 2015-04-29

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802396
Hyphenated Format 45802-396

Supplemental Identifiers

RxCUI
890785 890786
UNII
4805237NP5

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 gynazole 1 (source: ndc)
Generic Name butoconazole nitrate (source: ndc)
Application Number ANDA200923 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (2)

45802-396-01 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR 45802-396-02 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

butoconazole nitrate (100 mg/5g)

Linked Drug Pages (1)

gynazole 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "3953738b-1476-4a24-9e07-a7d3866d76a8", "openfda": {"unii": ["4805237NP5"], "rxcui": ["890785", "890786"], "spl_set_id": ["125d8ede-db38-4eb9-a6be-19208687f36a"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01)  / 5.8 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "45802-396-01", "marketing_start_date": "20150429"}, {"sample": true, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02)  / 5.8 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "45802-396-02", "marketing_start_date": "20150429"}], "brand_name": "gynazole 1", "product_id": "45802-396_3953738b-1476-4a24-9e07-a7d3866d76a8", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "45802-396", "generic_name": "butoconazole nitrate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gynazole 1", "active_ingredients": [{"name": "BUTOCONAZOLE NITRATE", "strength": "100 mg/5g"}], "application_number": "ANDA200923", "marketing_category": "ANDA", "marketing_start_date": "20150429", "listing_expiration_date": "20261231"}