oxiconazole nitrate

Generic: oxiconazole nitrate

Labeler: e. fougera & co. a division of fougera pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name oxiconazole nitrate
Generic Name oxiconazole nitrate
Labeler e. fougera & co. a division of fougera pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oxiconazole nitrate 10 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0168-0358
Product ID 0168-0358_3344432e-6592-4a42-869f-7c6f854ed681
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019828
Listing Expiration 2026-12-31
Marketing Start 2016-03-09

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01680358
Hyphenated Format 0168-0358

Supplemental Identifiers

RxCUI
312139
UPC
0301680358307
UNII
RQ8UL4C17S

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 oxiconazole nitrate (source: ndc)
Generic Name oxiconazole nitrate (source: ndc)
Application Number NDA019828 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 30 g in 1 TUBE (0168-0358-30)
  • 60 g in 1 TUBE (0168-0358-60)
  • 90 g in 1 TUBE (0168-0358-90)
source: ndc

Packages (3)

0168-0358-30 30 g in 1 TUBE (0168-0358-30) 0168-0358-60 60 g in 1 TUBE (0168-0358-60) 0168-0358-90 90 g in 1 TUBE (0168-0358-90)

Ingredients (1)

oxiconazole nitrate (10 mg/g)

Linked Drug Pages (1)

Oxiconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3344432e-6592-4a42-869f-7c6f854ed681", "openfda": {"upc": ["0301680358307"], "unii": ["RQ8UL4C17S"], "rxcui": ["312139"], "spl_set_id": ["aa368d2b-a5d2-49dd-86e1-5693b68b46f4"], "manufacturer_name": ["E. Fougera & Co. a division of Fougera Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (0168-0358-30)", "package_ndc": "0168-0358-30", "marketing_start_date": "20160309"}, {"sample": false, "description": "60 g in 1 TUBE (0168-0358-60)", "package_ndc": "0168-0358-60", "marketing_start_date": "20160309"}, {"sample": false, "description": "90 g in 1 TUBE (0168-0358-90)", "package_ndc": "0168-0358-90", "marketing_start_date": "20160310"}], "brand_name": "Oxiconazole Nitrate", "product_id": "0168-0358_3344432e-6592-4a42-869f-7c6f854ed681", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0168-0358", "generic_name": "Oxiconazole Nitrate", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxiconazole Nitrate", "active_ingredients": [{"name": "OXICONAZOLE NITRATE", "strength": "10 mg/g"}], "application_number": "NDA019828", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160309", "listing_expiration_date": "20261231"}