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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050514-001	NATACYN	NATAMYCIN	5%	SUSPENSION / OPHTHALMIC		RLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050514-001	NATACYN	5%	SUSPENSION / OPHTHALMIC	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NATAMYCIN	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8O0C852CPO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204451	Internal RxNorm lookup
207100	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
20ede08c-0d39-dc65-e063-6394a90aa3e0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e89db81-98c7-14a5-4bf2-ab0ee6489391	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82667-012-05	NATACYN	1 in 1 CARTON	SUSPENSION/ DROPS	1		2
82667-012-05	NATACYN	15 mL in 1 BOTTLE, GLASS	SUSPENSION/ DROPS	15		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82667-012-05	ML - Milliliter	82667-012	7a3d566a-0724-4585-814f-83f53f62fbff	1	2025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82667-012	NATACYN (NATAMYCIN) SUSPENSION/ DROPS [HARROW EYE, LLC]	1	Current NDC, 2 package rows	20241102_20ede08c-0d39-dc65-e063-6394a90aa3e0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NATACYN	NATAMYCIN	Eyevance Pharmaceuticals, LLC	2818fcb8-5bac-41fb-864e-3b598308a428	2025-11-05	Adverse reactions	Exact identifier application applno (NDA): 050514 application number: NDA050514
NATACYN	NATAMYCIN	Harrow Eye, LLC	20ede08c-0d39-dc65-e063-6394a90aa3e0	2025-10-30	Adverse reactions	Exact identifier application applno (NDA): 050514 application number: NDA050514 ndc (product): 82667-012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8O0C852CPO	NATAMYCIN	7681-93-8	NATAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207100	Natacyn 5 % Ophthalmic Suspension	PSN	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
204451	natamycin 5 % Ophthalmic Suspension	PSN	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
207100	natamycin 50 MG/ML Ophthalmic Suspension [Natacyn]	SBD	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
204451	natamycin 50 MG/ML Ophthalmic Suspension	SCD	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
207100	Natacyn 5 % Ophthalmic Suspension	SY	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
207100	Natacyn 50 MG/ML Ophthalmic Suspension	SY	20ede08c-0d39-dc65-e063-6394a90aa3e0	2
204451	natamycin 5 % Ophthalmic Suspension	SY	20ede08c-0d39-dc65-e063-6394a90aa3e0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82667-012-05	82667001205	1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS	2024-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NATACYN™ (natamycin ophthalmic suspension) 5% Anti-Fungal Ophthalmic Suspension Rx Only	Harrow Eye, LLC	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	2