Ketotifen Fumarate

Product NDC: 17478-717
11-digit product format: 174780717
Labeler code: 17478
Product ID: 17478-717_730d47be-f8fa-45a4-829d-e8b43c850c44
Type: HUMAN OTC DRUG
Nonproprietary name: Ketotifen Fumarate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA077958
Marketing category: ANDA
Marketing start: 2007-10-01
Marketing end: 0000-00-00
Substance: KETOTIFEN FUMARATE
Active strength: 0 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-717		I	Inactivated by FDA	2026-08-10
excluded package	package	17478-717	17478-717-10	I	Inactivated by FDA	2026-08-10
excluded package	package	17478-717	17478-717-11	D	Discontinued by firm	2026-08-10

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-717-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-717-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-717-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-717-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-717-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-717-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-717-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-717-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-717-11	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-717-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-717-11	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-717-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-717-11	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-717-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-717-11	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-717-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-717-11	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-717-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-717-11	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-717-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-717-11	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-717-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-717-11	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-717-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-717-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-717-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-717-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-717-10	2024-01-30	C162847	48780-1	1030e365-2b57-111a-e063-dadaa90a10e2	1376a697-bcf3-47a4-ba0d-8be7aa395c56
17478-717-11	2024-01-30	C162847	48780-1	1030e365-2b57-111a-e063-dadaa90a10e2	1376a697-bcf3-47a4-ba0d-8be7aa395c56

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-717-10	Ketotifen Fumarate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	9
17478-717-10	Ketotifen Fumarate	1 in 1 CARTON	SOLUTION/ DROPS	1	9
17478-717-11	Ketotifen Fumarate	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	9
17478-717-11	Ketotifen Fumarate	1 in 1 CARTON	SOLUTION/ DROPS	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-717-10	ML - Milliliter	17478-717	ce0e369a-3af1-4d5f-acd2-f493a3cfb1a6	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-717	KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN]	9	Legacy NDC, 4 package rows	20220914_1376a697-bcf3-47a4-ba0d-8be7aa395c56.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
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	1376a697-bcf3-47a4-ba0d-8be7aa395c56	9
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	1376a697-bcf3-47a4-ba0d-8be7aa395c56	9
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	1376a697-bcf3-47a4-ba0d-8be7aa395c56	9
311237	ketotifen 0.025 % Ophthalmic Solution	SY	1376a697-bcf3-47a4-ba0d-8be7aa395c56	9
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	1376a697-bcf3-47a4-ba0d-8be7aa395c56	9
311237	ketotifen 0.025 % Ophthalmic Solution	PSN	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	3
311237	ketotifen 0.25 MG/ML Ophthalmic Solution	SCD	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	3
311237	ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution	SY	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	3
311237	ketotifen 0.025 % Ophthalmic Solution	SY	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	3
311237	ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution	SY	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-717-10	17478071710	1 BOTTLE, DROPPER in 1 CARTON (17478-717-10) > 5 mL in 1 BOTTLE, DROPPER	2007-10-01	0000-00-00	No	No	Current
17478-717-11	17478071711	1 BOTTLE, DROPPER in 1 CARTON (17478-717-11) > 10 mL in 1 BOTTLE, DROPPER	2016-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketotifen Fumarate - A-S Medication Solutions	A-S Medication Solutions	2024-07-02	HUMAN OTC DRUG LABEL	17
Ketotifen Fumarate - Akorn \| Akorn AG	Akorn \| Akorn AG	2022-09-12	HUMAN OTC DRUG LABEL	9
Ketotifen Fumarate - REMEDYREPACK INC.	REMEDYREPACK INC.	2022-07-11	HUMAN OTC DRUG LABEL	7
KETOTIFEN FUMARATE	DIRECT RX	2021-05-21	HUMAN OTC DRUG LABEL	3
Ketotifen Fumarate - Proficient Rx LP	Proficient Rx LP	2019-10-01	HUMAN OTC DRUG LABEL	3