monistat tioconazole 1

Generic: tioconazole

Labeler: insight pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name monistat tioconazole 1
Generic Name tioconazole
Labeler insight pharmaceuticals llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

tioconazole 6.5 g/100g

Manufacturer
Insight Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 63736-413
Product ID 63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075915
Listing Expiration 2026-12-31
Marketing Start 2001-11-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63736413
Hyphenated Format 63736-413

Supplemental Identifiers

RxCUI
198380 1661176
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 monistat tioconazole 1 (source: ndc)
Generic Name tioconazole (source: ndc)
Application Number ANDA075915 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 6.5 g/100g
source: ndc
Packaging
  • 1 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATOR
source: ndc

Packages (1)

63736-413-01 1 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATOR

Ingredients (1)

tioconazole (6.5 g/100g)

Linked Drug Pages (1)

MONISTAT TIOCONAZOLE 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["S57Y5X1117"], "rxcui": ["198380", "1661176"], "spl_set_id": ["587e42b4-cbdc-4a03-afae-f9e5e6605937"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Insight Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 APPLICATOR in 1 CARTON (63736-413-01)  / 4.6 g in 1 APPLICATOR", "package_ndc": "63736-413-01", "marketing_start_date": "20011121"}], "brand_name": "MONISTAT TIOCONAZOLE 1", "product_id": "63736-413_c7b11d34-bd8a-4c84-aa4c-2cc6cf9037df", "dosage_form": "OINTMENT", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "63736-413", "generic_name": "TIOCONAZOLE", "labeler_name": "Insight Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MONISTAT TIOCONAZOLE 1", "active_ingredients": [{"name": "TIOCONAZOLE", "strength": "6.5 g/100g"}], "application_number": "ANDA075915", "marketing_category": "ANDA", "marketing_start_date": "20011121", "listing_expiration_date": "20261231"}