vagistat

Generic: tioconazole

Labeler: combe incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vagistat
Generic Name tioconazole
Labeler combe incorporated
Dosage Form OINTMENT
Routes
VAGINAL
Active Ingredients

tioconazole 6.5 g/100g

Manufacturer
Combe Incorporated

Identifiers & Regulatory

Product NDC 11509-0426
Product ID 11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075915
Listing Expiration 2026-12-31
Marketing Start 2020-07-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115090426
Hyphenated Format 11509-0426

Supplemental Identifiers

RxCUI
198380 1550534
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 vagistat (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 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
source: ndc

Packages (1)

11509-0426-1 1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR

Ingredients (1)

tioconazole (6.5 g/100g)

Linked Drug Pages (1)

VAGISTAT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "8c436269-2f52-4ddf-b3be-cec3069a8865", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["S57Y5X1117"], "rxcui": ["198380", "1550534"], "spl_set_id": ["da8eaa33-4195-487f-a234-472dd1036225"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Combe Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (11509-0426-1)  / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR", "package_ndc": "11509-0426-1", "marketing_start_date": "20200729"}], "brand_name": "VAGISTAT", "product_id": "11509-0426_8c436269-2f52-4ddf-b3be-cec3069a8865", "dosage_form": "OINTMENT", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "11509-0426", "generic_name": "Tioconazole", "labeler_name": "Combe Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "VAGISTAT", "active_ingredients": [{"name": "TIOCONAZOLE", "strength": "6.5 g/100g"}], "application_number": "ANDA075915", "marketing_category": "ANDA", "marketing_start_date": "20200729", "listing_expiration_date": "20261231"}