FDA.reportPublic FDA data

KETOTIFEN FUMARATE

Product NDC
76385-106
11-digit product format
763850106
Labeler code
76385
Product ID
76385-106_948d4259-9d62-4bc7-9149-6961034364bf
Type
HUMAN OTC DRUG
Nonproprietary name
KETOTIFEN FUMARATE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA204059
Marketing category
ANDA
Marketing start
2021-10-15
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204059-001KETOTIFEN FUMARATEKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204059-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-06-01a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
KETOTIFEN FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HBD503WOROInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311237Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fe119ad-cb44-4e90-a096-0ed0ba63dc31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-106-17KETOTIFEN FUMARATE5 mL in 1 BOTTLE, PLASTICSOLUTION52
76385-106-17KETOTIFEN FUMARATE1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-106-17ML - Milliliter76385-10652aeb84b-fce7-4594-8717-c726c4d5c98812021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-106KETOTIFEN FUMARATE SOLUTION [BAYSHORE PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20211023_0fe119ad-cb44-4e90-a096-0ed0ba63dc31.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketotifen FumarateKETOTIFEN FUMARATEPreferred Pharmaceuticals Inc.5196ec5b-42d9-40db-a77a-c00360b8cee62026-05-15WarningsExact identifier
application applno (ANDA): 204059
application number: ANDA204059
KETOTIFEN FUMARATEKETOTIFEN FUMARATEUnichem Pharmaceuticals (USA), Inc.0fe119ad-cb44-4e90-a096-0ed0ba63dc312025-11-24Exact identifier
application applno (ANDA): 204059
application number: ANDA204059
ndc (product): 76385-106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN5196ec5b-42d9-40db-a77a-c00360b8cee63
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD5196ec5b-42d9-40db-a77a-c00360b8cee63
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY5196ec5b-42d9-40db-a77a-c00360b8cee63
311237ketotifen 0.025 % Ophthalmic SolutionSY5196ec5b-42d9-40db-a77a-c00360b8cee63
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY5196ec5b-42d9-40db-a77a-c00360b8cee63
311237ketotifen 0.025 % Ophthalmic SolutionPSN0fe119ad-cb44-4e90-a096-0ed0ba63dc312
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD0fe119ad-cb44-4e90-a096-0ed0ba63dc312
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY0fe119ad-cb44-4e90-a096-0ed0ba63dc312
311237ketotifen 0.025 % Ophthalmic SolutionSY0fe119ad-cb44-4e90-a096-0ed0ba63dc312
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY0fe119ad-cb44-4e90-a096-0ed0ba63dc312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76385-106-17763850106171 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) / 5 mL in 1 BOTTLE, PLASTIC2021-10-150000-00-00NoNoCurrent