terconazole vaginal cream 0.8%

Generic: terconazole

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

Drug Facts

Product Profile

Brand Name terconazole vaginal cream 0.8%
Generic Name terconazole
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

terconazole 8 mg/g

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

Identifiers & Regulatory

Product NDC 0168-0347
Product ID 0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021735
Listing Expiration 2027-12-31
Marketing Start 2005-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680347
Hyphenated Format 0168-0347

Supplemental Identifiers

RxCUI
313227
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 vaginal cream 0.8% (source: ndc)
Generic Name terconazole (source: ndc)
Application Number NDA021735 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/g
source: ndc
Packaging
  • 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)
source: ndc

Packages (1)

0168-0347-20 20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)

Ingredients (1)

terconazole (8 mg/g)

Linked Drug Pages (1)

Terconazole Vaginal Cream 0.8% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "4b5df750-9341-4786-8e10-b0d6950f37ed", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["0KJ2VE664U"], "rxcui": ["313227"], "spl_set_id": ["f59448bd-f730-46d2-a785-c2d6205579ff"], "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": "20 g in 1 TUBE, WITH APPLICATOR (0168-0347-20)", "package_ndc": "0168-0347-20", "marketing_start_date": "20201201"}], "brand_name": "Terconazole Vaginal Cream 0.8%", "product_id": "0168-0347_4b5df750-9341-4786-8e10-b0d6950f37ed", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0168-0347", "generic_name": "terconazole", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terconazole", "brand_name_suffix": "Vaginal Cream 0.8%", "active_ingredients": [{"name": "TERCONAZOLE", "strength": "8 mg/g"}], "application_number": "NDA021735", "marketing_category": "NDA", "marketing_start_date": "20050201", "listing_expiration_date": "20271231"}