terconazole

Generic: terconazole

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terconazole
Generic Name terconazole
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

terconazole 4 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0346
Product ID 0168-0346_c54c82fd-d8e5-4943-8727-1432bccac7c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076712
Listing Expiration 2027-12-31
Marketing Start 2005-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680346
Hyphenated Format 0168-0346

Supplemental Identifiers

RxCUI
313226
UPC
0301680346465
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 ANDA076712 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
source: ndc
Packaging
  • 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)
source: ndc

Packages (1)

0168-0346-46 45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)

Ingredients (1)

terconazole (4 mg/g)

Linked Drug Pages (1)

Terconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "c54c82fd-d8e5-4943-8727-1432bccac7c2", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0301680346465"], "unii": ["0KJ2VE664U"], "rxcui": ["313226"], "spl_set_id": ["10e84353-93d2-461d-8b79-e9294df047ae"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "45 g in 1 TUBE, WITH APPLICATOR (0168-0346-46)", "package_ndc": "0168-0346-46", "marketing_start_date": "20050218"}], "brand_name": "Terconazole", "product_id": "0168-0346_c54c82fd-d8e5-4943-8727-1432bccac7c2", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0168-0346", "generic_name": "terconazole", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "4 mg/g"}], "application_number": "ANDA076712", "marketing_category": "ANDA", "marketing_start_date": "20050218", "listing_expiration_date": "20271231"}