Home NDC 68788-8715 Ketotifen Fumarate
Product NDC 68788-8715
11-digit product format 687888715
Labeler code 68788
Product ID 68788-8715_45477f1c-fa33-4ecc-b608-67280f68385a
Type HUMAN OTC DRUG
Nonproprietary name Ketotifen Fumarate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Preferred Pharmaceuticals Inc.
Application ANDA204059
Marketing category ANDA
Marketing start 2024-07-12
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 2027-12-31
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 A204059-001 KETOTIFEN FUMARATE KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204059-001 KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC 2020-06-01 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Ketotifen Fumarate
Listing expiration 2027-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8715-5 Ketotifen Fumarate 1 in 1 CARTON SOLUTION 1 3 68788-8715-5 Ketotifen Fumarate 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8715 KETOTIFEN FUMARATE SOLUTION [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20240727_5196ec5b-42d9-40db-a77a-c00360b8cee6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68788-8715-5 68788871505 1 BOTTLE, PLASTIC in 1 CARTON (68788-8715-5) / 5 mL in 1 BOTTLE, PLASTIC 2024-07-12 No No Current