oxistat

Generic: oxiconazole nitrate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxistat
Generic Name oxiconazole nitrate
Labeler ani pharmaceuticals, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

oxiconazole nitrate 10 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-285
Product ID 62559-285_c38f8751-f5da-4333-b12a-2ca8c1816a32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020209
Listing Expiration 2026-12-31
Marketing Start 2022-09-12

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559285
Hyphenated Format 62559-285

Supplemental Identifiers

RxCUI
207249 312140
UPC
0362559285308
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 oxistat (source: ndc)
Generic Name oxiconazole nitrate (source: ndc)
Application Number NDA020209 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (62559-285-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (3)

62559-285-06 6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE 62559-285-30 1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE 62559-285-60 1 BOTTLE in 1 CARTON (62559-285-60) / 60 mL in 1 BOTTLE

Ingredients (1)

oxiconazole nitrate (10 mg/mL)

Linked Drug Pages (1)

Oxistat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c38f8751-f5da-4333-b12a-2ca8c1816a32", "openfda": {"upc": ["0362559285308"], "unii": ["RQ8UL4C17S"], "rxcui": ["207249", "312140"], "spl_set_id": ["64ef2286-0f56-4a8a-b07b-4a597f078ae0"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE in 1 CARTON (62559-285-06)  / 7 mL in 1 BOTTLE", "package_ndc": "62559-285-06", "marketing_start_date": "20220912"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62559-285-30)  / 30 mL in 1 BOTTLE", "package_ndc": "62559-285-30", "marketing_start_date": "20220912"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62559-285-60)  / 60 mL in 1 BOTTLE", "package_ndc": "62559-285-60", "marketing_start_date": "20220912"}], "brand_name": "Oxistat", "product_id": "62559-285_c38f8751-f5da-4333-b12a-2ca8c1816a32", "dosage_form": "LOTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "62559-285", "generic_name": "oxiconazole nitrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxistat", "active_ingredients": [{"name": "OXICONAZOLE NITRATE", "strength": "10 mg/mL"}], "application_number": "NDA020209", "marketing_category": "NDA", "marketing_start_date": "20220912", "listing_expiration_date": "20261231"}