Package 45802-396-02
Brand: gynazole 1
Generic: butoconazole nitratePackage Facts
Identity
Package NDC
45802-396-02
Digits Only
4580239602
Product NDC
45802-396
Description
1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR
Marketing
Marketing Status
Brand
gynazole 1
Generic
butoconazole nitrate
Sample Package
Yes
Linked Drug Pages (1)
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"}