tioconazole 1

Generic: tioconazole

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tioconazole 1
Generic Name tioconazole
Labeler h e b
Dosage Form OINTMENT
Routes
VAGINAL
Active Ingredients

tioconazole 6.5 g/100g

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-426
Product ID 37808-426_0c72d07d-86cc-443d-96a8-8ec00e1cfa7c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075915
Listing Expiration 2026-12-31
Marketing Start 2016-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808426
Hyphenated Format 37808-426

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 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 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR
source: ndc

Packages (1)

37808-426-54 1 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR

Ingredients (1)

tioconazole (6.5 g/100g)

Linked Drug Pages (1)

Tioconazole 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "0c72d07d-86cc-443d-96a8-8ec00e1cfa7c", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["S57Y5X1117"], "rxcui": ["198380"], "spl_set_id": ["8bd3f5e8-5a8f-4d6a-b257-c315eec66318"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (37808-426-54)  / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR", "package_ndc": "37808-426-54", "marketing_start_date": "20160509"}], "brand_name": "Tioconazole 1", "product_id": "37808-426_0c72d07d-86cc-443d-96a8-8ec00e1cfa7c", "dosage_form": "OINTMENT", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "37808-426", "generic_name": "Tioconazole", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tioconazole 1", "active_ingredients": [{"name": "TIOCONAZOLE", "strength": "6.5 g/100g"}], "application_number": "ANDA075915", "marketing_category": "ANDA", "marketing_start_date": "20160509", "listing_expiration_date": "20261231"}