ertaczo

Generic: sertaconazole nitrate

Labeler: coral way pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertaczo
Generic Name sertaconazole nitrate
Labeler coral way pharma, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

sertaconazole nitrate 20 mg/g

Manufacturer
Coral Way Pharma, LLC

Identifiers & Regulatory

Product NDC 85437-004
Product ID 85437-004_43087fb0-8277-dca4-e063-6294a90a86a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021385
Listing Expiration 2026-12-31
Marketing Start 2025-11-07

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85437004
Hyphenated Format 85437-004

Supplemental Identifiers

RxCUI
250511 580294
UPC
0385437004600
UNII
1DV05410M5

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 ertaczo (source: ndc)
Generic Name sertaconazole nitrate (source: ndc)
Application Number NDA021385 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE
source: ndc

Packages (1)

85437-004-60 1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE

Ingredients (1)

sertaconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Ertaczo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "43087fb0-8277-dca4-e063-6294a90a86a3", "openfda": {"upc": ["0385437004600"], "unii": ["1DV05410M5"], "rxcui": ["250511", "580294"], "spl_set_id": ["c6fa8dc4-2620-474e-a9b4-6657d9cbfa96"], "manufacturer_name": ["Coral Way Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (85437-004-60)  / 60 g in 1 TUBE", "package_ndc": "85437-004-60", "marketing_start_date": "20251107"}], "brand_name": "Ertaczo", "product_id": "85437-004_43087fb0-8277-dca4-e063-6294a90a86a3", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "85437-004", "generic_name": "Sertaconazole Nitrate", "labeler_name": "Coral Way Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertaczo", "active_ingredients": [{"name": "SERTACONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "NDA021385", "marketing_category": "NDA", "marketing_start_date": "20251107", "listing_expiration_date": "20261231"}