natacyn

Generic: natamycin

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name natacyn
Generic Name natamycin
Labeler harrow eye, llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

natamycin 50 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-012
Product ID 82667-012_42678f74-383b-962f-e063-6394a90a3315
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050514
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Established (EPC)
polyene antimicrobial [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667012
Hyphenated Format 82667-012

Supplemental Identifiers

RxCUI
204451 207100
UNII
8O0C852CPO
NUI
N0000175936 M0017172

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 natacyn (source: ndc)
Generic Name natamycin (source: ndc)
Application Number NDA050514 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

82667-012-05 1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS

Ingredients (1)

natamycin (50 mg/mL)

Linked Drug Pages (1)

NATACYN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "42678f74-383b-962f-e063-6394a90a3315", "openfda": {"nui": ["N0000175936", "M0017172"], "unii": ["8O0C852CPO"], "rxcui": ["204451", "207100"], "spl_set_id": ["20ede08c-0d39-dc65-e063-6394a90aa3e0"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antimicrobial [EPC]"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (82667-012-05)  / 15 mL in 1 BOTTLE, GLASS", "package_ndc": "82667-012-05", "marketing_start_date": "20241101"}], "brand_name": "NATACYN", "product_id": "82667-012_42678f74-383b-962f-e063-6394a90a3315", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Polyene Antimicrobial [EPC]", "Polyenes [CS]"], "product_ndc": "82667-012", "generic_name": "natamycin", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NATACYN", "active_ingredients": [{"name": "NATAMYCIN", "strength": "50 mg/mL"}], "application_number": "NDA050514", "marketing_category": "NDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}