ACUVAIL

Product NDC: 0023-3507
11-digit product format: 000233507
Labeler code: 0023
Product ID: 0023-3507_ee96bc53-04b7-4ea7-8fab-835ed3648561
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA022427
Marketing category: NDA
Marketing start: 2009-08-01
Substance: KETOROLAC TROMETHAMINE
Active strength: 4.5 mg/mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0023-3507	0023-3507-30	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N022427-001	ACUVAIL	KETOROLAC TROMETHAMINE	0.45%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2009-07-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022427-001	8512717	2028-03-07	Drug product	2013-09-19
N022427-001	9192571	2028-03-07	Drug product	2015-12-21
N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30

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	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022427-001	ACUVAIL	0.45%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2009-07-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 158 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022427-001	8512717	2028-03-07	Drug product	2013-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022427-001	9192571	2028-03-07	Drug product	2015-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022427-001	7842714	2029-08-15	Drug substance, Drug product	2010-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022427-001	8992952	2024-08-05	Drug product	2015-04-10	`301d65b070ca…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	4.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4EVE5946BQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858364	Internal RxNorm lookup
858366	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
3cea5803-a446-4d2c-9747-f3fb034332c8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0023-3507-05	ACUVAIL	0.4 mL in 1 VIAL, SINGLE-DOSE	SOLUTION/ DROPS	0.4	19
0023-3507-05	ACUVAIL	5 in 1 CARTON	SOLUTION/ DROPS	5	19
0023-3507-30	ACUVAIL	30 in 1 CARTON	SOLUTION/ DROPS	30	19
0023-3507-30	ACUVAIL	0.4 mL in 1 VIAL, SINGLE-DOSE	SOLUTION/ DROPS	0.4	19
0023-3507-31	ACUVAIL	10 in 1 POUCH	SOLUTION/ DROPS	10	19
0023-3507-31	ACUVAIL	3 in 1 CARTON	SOLUTION/ DROPS	3	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-3507-30	EA - Each	0023-3507	4cd5a672-353b-4ff3-ae47-4a09072ad991	1	2012-07-24
0023-3507-31	EA - Each	0023-3507	398645df-bfeb-4754-9905-34d9c737ffb6	1	2021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ketorolac tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
ketorolac	ACTIVE MOIETY	YZI5105V0L	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8
water	INACTIVE INGREDIENT	059QF0KO0R	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-3507	ACUVAIL (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	19	Current NDC, Legacy NDC, 6 package rows	20240730_3cea5803-a446-4d2c-9747-f3fb034332c8.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
ACUVAIL	KETOROLAC TROMETHAMINE	Allergan, Inc.	3cea5803-a446-4d2c-9747-f3fb034332c8	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022427 application number: NDA022427 ndc (product): 0023-3507

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4EVE5946BQ	KETOROLAC TROMETHAMINE	74103-07-4	KETOROLAC TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858366	ACUVAIL 0.45 % Ophthalmic Solution	PSN	3cea5803-a446-4d2c-9747-f3fb034332c8	19
858364	ketorolac tromethamine 0.45 % Ophthalmic Solution	PSN	3cea5803-a446-4d2c-9747-f3fb034332c8	19
858366	ketorolac tromethamine 4.5 MG/ML Ophthalmic Solution [Acuvail]	SBD	3cea5803-a446-4d2c-9747-f3fb034332c8	19
858364	ketorolac tromethamine 4.5 MG/ML Ophthalmic Solution	SCD	3cea5803-a446-4d2c-9747-f3fb034332c8	19
858366	Acuvail 0.45 % Ophthalmic Solution	SY	3cea5803-a446-4d2c-9747-f3fb034332c8	19
858364	ketorolac tromethamine 0.45 % Ophthalmic Solution	SY	3cea5803-a446-4d2c-9747-f3fb034332c8	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-3507-05	00023350705	5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE		2009-08-01	0000-00-00	Yes	No	Current
0023-3507-30	00023350730	30 VIAL, SINGLE-USE in 1 CARTON (0023-3507-30) > .4 mL in 1 VIAL, SINGLE-USE		2009-08-01	2022-04-30	No	No	Current
0023-3507-31	00023350731	3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE	3 pouch	2009-08-01	0000-00-00	No	No	Current