terconazole

Generic: terconazole

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

Drug Facts

Product Profile

Brand Name terconazole
Generic Name terconazole
Labeler padagis israel pharmaceuticals ltd
Dosage Form SUPPOSITORY
Routes
VAGINAL
Active Ingredients

terconazole 80 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-717
Product ID 45802-717_5def32af-7e22-4dbf-b0cd-aca45e2987b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077149
Listing Expiration 2026-12-31
Marketing Start 2006-08-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802717
Hyphenated Format 45802-717

Supplemental Identifiers

RxCUI
198245
UNII
0KJ2VE664U
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 terconazole (source: ndc)
Generic Name terconazole (source: ndc)
Application Number ANDA077149 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (45802-717-08) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)
source: ndc

Packages (1)

45802-717-08 3 BLISTER PACK in 1 CARTON (45802-717-08) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)

Ingredients (1)

terconazole (80 mg/1)

Linked Drug Pages (1)

Terconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "5def32af-7e22-4dbf-b0cd-aca45e2987b0", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["198245"], "spl_set_id": ["207e9cf2-e8ec-43d7-9c11-46283c9cdb37"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (45802-717-08)  / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00)", "package_ndc": "45802-717-08", "marketing_start_date": "20060828"}], "brand_name": "Terconazole", "product_id": "45802-717_5def32af-7e22-4dbf-b0cd-aca45e2987b0", "dosage_form": "SUPPOSITORY", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "45802-717", "generic_name": "Terconazole", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "80 mg/1"}], "application_number": "ANDA077149", "marketing_category": "ANDA", "marketing_start_date": "20060828", "listing_expiration_date": "20261231"}