leader tioconazole 1

Generic: tioconazole

Labeler: cardinal health 110, llc. dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leader tioconazole 1
Generic Name tioconazole
Labeler cardinal health 110, llc. dba leader
Dosage Form OINTMENT
Routes
VAGINAL
Active Ingredients

tioconazole 6.5 g/100g

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0357
Product ID 70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075915
Listing Expiration 2026-12-31
Marketing Start 2018-04-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000357
Hyphenated Format 70000-0357

Supplemental Identifiers

RxCUI
198380
UNII
S57Y5X1117
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 leader tioconazole 1 (source: ndc)
Generic Name tioconazole (source: ndc)
Application Number ANDA075915 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 6.5 g/100g
source: ndc
Packaging
  • 1 APPLICATOR in 1 CARTON (70000-0357-1) / 4.6 g in 1 APPLICATOR
source: ndc

Packages (1)

70000-0357-1 1 APPLICATOR in 1 CARTON (70000-0357-1) / 4.6 g in 1 APPLICATOR

Ingredients (1)

tioconazole (6.5 g/100g)

Linked Drug Pages (1)

Leader Tioconazole 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "d5dec365-3936-4367-9df2-57a919a11eb3", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["S57Y5X1117"], "rxcui": ["198380"], "spl_set_id": ["6db31d83-acd7-4e4e-8f98-fe46102a6832"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 CARTON (70000-0357-1)  / 4.6 g in 1 APPLICATOR", "package_ndc": "70000-0357-1", "marketing_start_date": "20180420"}], "brand_name": "Leader Tioconazole 1", "product_id": "70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3", "dosage_form": "OINTMENT", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "70000-0357", "generic_name": "Tioconazole", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Tioconazole 1", "active_ingredients": [{"name": "TIOCONAZOLE", "strength": "6.5 g/100g"}], "application_number": "ANDA075915", "marketing_category": "ANDA", "marketing_start_date": "20180420", "listing_expiration_date": "20261231"}