Ketotifen Fumarate Ophthalmic Solution

Product NDC: 72485-617
11-digit product format: 724850617
Labeler code: 72485
Product ID: 72485-617_cd02d900-5bfc-494b-a588-8f6098fe058e
Type: HUMAN OTC DRUG
Nonproprietary name: Ketotifen Fumarate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA077958
Marketing category: ANDA
Marketing start: 2023-10-09
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
A077958-001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2007-07-26

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ketotifen Fumarate Ophthalmic Solution
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	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	Strength	SPL version
72485-617-10	Ketotifen Fumarate Ophthalmic Solution	1 in 1 CARTON	SOLUTION/ DROPS	1		4
72485-617-10	Ketotifen Fumarate Ophthalmic Solution	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-617	KETOTIFEN FUMARATE OPHTHALMIC SOLUTION (KETOTIFEN FUMARATE) SOLUTION/ DROPS [ARMAS PHARMACEUTICALS INC.]	4	Current NDC, 2 package rows	20240102_b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Sentiss Pharmaceuticals LLC	7e7be193-63ec-474d-a596-e22fc8b1be0f	2026-04-15	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Preferred Pharmaceuticals Inc.	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Eye Itch Relief	KETOTIFEN FUMARATE	CARDINAL HEALTH 110, LLC. DBA LEADER	add414c5-b6c5-4bb5-8d8a-ddc507a27131	2025-09-12	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Armas Pharmaceuticals Inc.	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	2024-01-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958 ndc (product): 72485-617
Ketotifen Fumarate	KETOTIFEN FUMARATE	Proficient Rx LP	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	2019-10-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958

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	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	4
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	4
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	4
311237	ketotifen 0.025 % Ophthalmic Solution	SY	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	4
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	4
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2
311237	ketotifen 0.025 % Ophthalmic Solution	SY	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72485-617-10	72485061710	1 BOTTLE, DROPPER in 1 CARTON (72485-617-10) / 5 mL in 1 BOTTLE, DROPPER	2023-10-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketotifen Fumarate Ophthalmic Solution	Preferred Pharmaceuticals Inc.	2026-03-18	HUMAN OTC DRUG LABEL	2
Ketotifen Fumarate Ophthalmic Solution	Armas Pharmaceuticals Inc. \| SENTISS AG	2024-01-01	HUMAN OTC DRUG LABEL	4