NATACYN

Product NDC
82667-012
11-digit product format
826670012
Labeler code
82667
Product ID
82667-012_42678f74-383b-962f-e063-6394a90a3315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
natamycin
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA050514
Marketing category
NDA
Marketing start
2024-11-01
Substance
NATAMYCIN
Active strength
50 mg/mL
Pharmacologic classes
Polyene Antimicrobial [EPC], Polyenes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NATACYN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NATAMYCIN50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8O0C852CPO
Rxcui204451, 207100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e89db81-98c7-14a5-4bf2-ab0ee6489391Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-012-05NATACYN1 in 1 CARTONSUSPENSION/ DROPS12
82667-012-05NATACYN15 mL in 1 BOTTLE, GLASSSUSPENSION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-012-05ML - Milliliter82667-0127a3d566a-0724-4585-814f-83f53f62fbff12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-012NATACYN (NATAMYCIN) SUSPENSION/ DROPS [HARROW EYE, LLC]1Current NDC, 2 package rows20241102_20ede08c-0d39-dc65-e063-6394a90aa3e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207100Natacyn 5 % Ophthalmic SuspensionPSN20ede08c-0d39-dc65-e063-6394a90aa3e02
204451natamycin 5 % Ophthalmic SuspensionPSN20ede08c-0d39-dc65-e063-6394a90aa3e02
207100natamycin 50 MG/ML Ophthalmic Suspension [Natacyn]SBD20ede08c-0d39-dc65-e063-6394a90aa3e02
204451natamycin 50 MG/ML Ophthalmic SuspensionSCD20ede08c-0d39-dc65-e063-6394a90aa3e02
207100Natacyn 5 % Ophthalmic SuspensionSY20ede08c-0d39-dc65-e063-6394a90aa3e02
207100Natacyn 50 MG/ML Ophthalmic SuspensionSY20ede08c-0d39-dc65-e063-6394a90aa3e02
204451natamycin 5 % Ophthalmic SuspensionSY20ede08c-0d39-dc65-e063-6394a90aa3e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-012-05826670012051 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS2024-11-01NoNoHistorical