Zaditor

Product NDC: 0065-4011
11-digit product format: 000654011
Labeler code: 0065
Product ID: 0065-4011_bed738a0-2943-46e7-a65e-2440dac7971b
Type: HUMAN OTC DRUG
Nonproprietary name: ketotifen fumarate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: ANDA077200
Marketing category: ANDA
Marketing start: 2013-01-08
Substance: KETOTIFEN FUMARATE
Active strength: .25 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
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
A077200-001	ZADITOR	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC		RS	2008-09-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077200-001	ZADITOR	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RS	2008-09-02	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOTIFEN FUMARATE	.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HBD503WORO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284380	Internal RxNorm lookup
311237	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
ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229	Product name	1	20221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-4011-05	Zaditor	1 in 1 CARTON	SOLUTION	1	13
0065-4011-05	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13
0065-4011-06	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13
0065-4011-06	Zaditor	2 in 1 CARTON	SOLUTION	2	13
0065-4011-11	Zaditor	3 in 1 CARTON	SOLUTION	3	13
0065-4011-11	Zaditor	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-4011-05	ML - Milliliter	0065-4011	d2e44039-5e3f-41fc-8e6d-295be35be56f	1	2013-06-04
0065-4011-06	ML - Milliliter	0065-4011	93506bc4-71c8-42e1-8d9b-cc40360ee643	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketotifen Fumarate	ACTIVE INGREDIENT	HBD503WORO	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Ketotifen	ACTIVE MOIETY	X49220T18G	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-4011	ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]	13	Current NDC, Legacy NDC, 6 package rows	20231216_ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zaditor	KETOTIFEN FUMARATE	Alcon Laboratories, Inc.	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	2023-12-15	Warnings	Exact identifier application applno (ANDA): 077200 application number: ANDA077200 ndc (product): 0065-4011

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HBD503WORO	KETOTIFEN FUMARATE	34580-14-8	KETOTIFEN FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
284380	Zaditor 0.025 % Ophthalmic Solution	PSN	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
284380	ketotifen 0.25 MG/ML Ophthalmic Solution [Zaditor]	SBD	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
311237	ketotifen 0.025 % Ophthalmic Solution	SY	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
284380	Zaditor 0.025 % (ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
284380	Zaditor 0.25 MG/ML Ophthalmic Solution	SY	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	13
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	7a00b07f-3bc6-47be-8063-b2b076c69191	5
284380	Zaditor 0.025 % Ophthalmic Solution	PSN	7a00b07f-3bc6-47be-8063-b2b076c69191	5
284380	ketotifen 0.25 MG/ML Ophthalmic Solution [Zaditor]	SBD	7a00b07f-3bc6-47be-8063-b2b076c69191	5
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	7a00b07f-3bc6-47be-8063-b2b076c69191	5
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	7a00b07f-3bc6-47be-8063-b2b076c69191	5
311237	ketotifen 0.025 % Ophthalmic Solution	SY	7a00b07f-3bc6-47be-8063-b2b076c69191	5
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	7a00b07f-3bc6-47be-8063-b2b076c69191	5
284380	Zaditor 0.025 % (ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	7a00b07f-3bc6-47be-8063-b2b076c69191	5
284380	Zaditor 0.25 MG/ML Ophthalmic Solution	SY	7a00b07f-3bc6-47be-8063-b2b076c69191	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-4011-05	00065401105	1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) / 5 mL in 1 BOTTLE, DROPPER	2013-03-13	0000-00-00	No	No	Current
0065-4011-06	00065401106	2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) / 5 mL in 1 BOTTLE, DROPPER	2013-01-08	0000-00-00	No	No	Current
0065-4011-11	00065401111	3 BOTTLE, DROPPER in 1 CARTON (0065-4011-11) / 5 mL in 1 BOTTLE, DROPPER	2015-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Alcon Laboratories, Inc. \| Alcon Research LLC	2023-12-15	HUMAN OTC DRUG LABEL	13
DRUG FACTS	A-S Medication Solutions	2017-11-09	HUMAN OTC DRUG LABEL	5