NATACYN

Product NDC: 0065-0645
Requested package NDC: 0065-0645-15
11-digit product format: 000650645
Labeler code: 0065
Product ID: 0065-0645_2da3aab5-1d0b-4e95-a161-355bcb396497
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: natamycin
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA050514
Marketing category: NDA
Marketing start: 1980-12-31
Marketing end: 2022-03-31
Substance: NATAMYCIN
Active strength: 50 mg/mL
Pharmacologic classes: Polyene Antimicrobial [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0065-0645	0065-0645-15	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0645-15	ML - Milliliter	0065-0645	697e1ef7-e1d6-4b57-aa75-b527222692b5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NATAMYCIN	ACTIVE INGREDIENT	8O0C852CPO	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2
NATAMYCIN	ACTIVE MOIETY	8O0C852CPO	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NATACYN (NATAMYCIN) SUSPENSION [ALCON LABORATORIES, INC.]	2

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0645-15	00065064515	1 BOTTLE, GLASS in 1 CARTON (0065-0645-15) > 15 mL in 1 BOTTLE, GLASS	1980-12-31	2022-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NATACYN ® (natamycin ophthalmic suspension) 5% Sterile	Alcon Laboratories, Inc.	2022-03-16	HUMAN PRESCRIPTION DRUG LABEL	11