ACULAR LS

Product NDC: 0023-9277
Requested package NDC: 0023-9277-05
11-digit product format: 000239277
Labeler code: 0023
Product ID: 0023-9277_f32f9ea9-db8d-4b27-950c-36357ee01db5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA021528
Marketing category: NDA
Marketing start: 2003-08-19
Substance: KETOROLAC TROMETHAMINE
Active strength: 4 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
N021528-001	ACULAR LS	KETOROLAC TROMETHAMINE	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23
N021528-001	8008338*PED	2027-11-24		Pediatric extension

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 · 45 observed 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
2026-11-14 07:37:17	2026-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC		RLD	2003-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021528-001	ACULAR LS	0.4%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2003-05-30	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021528-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021528-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021528-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021528-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021528-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021528-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021528-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021528-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021528-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021528-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021528-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021528-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021528-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021528-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021528-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021528-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021528-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021528-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021528-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021528-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021528-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021528-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021528-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021528-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021528-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021528-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021528-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021528-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021528-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021528-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021528-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021528-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021528-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021528-001	AT	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 440 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8207215	2024-05-28	U-1251		2012-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8377982	2024-05-28	U-1363		2013-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8541463	2024-05-28	U-1441		2013-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8648107	2024-05-28		Drug product	2014-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8906950	2024-05-28	U-1626		2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8946281	2024-05-28	U-1662		2015-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	9216167	2024-05-28	U-1800		2016-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8207215*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8377982*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8541463*PED	2024-11-28		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8008338	2027-05-24	U-1181	Drug substance, Drug product	2011-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021528-001	8008338*PED	2027-11-24		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8207215	2024-05-28	U-1251		2012-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8377982	2024-05-28	U-1363		2013-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8541463	2024-05-28	U-1441		2013-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8648107	2024-05-28		Drug product	2014-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8906950	2024-05-28	U-1626		2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8946281	2024-05-28	U-1662		2015-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	9216167	2024-05-28	U-1800		2016-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8207215*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8377982*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021528-001	8541463*PED	2024-11-28		Pediatric extension		`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ACULAR LS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	4 mg/mL

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	Strength	SPL version
0023-9277-05	ACULAR LS	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		17
0023-9277-05	ACULAR LS	1 in 1 CARTON	SOLUTION/ DROPS	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-9277-05	ML - Milliliter	0023-9277	bee14956-f377-4e45-bd20-600eb70ed8b6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ketorolac tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
ketorolac	ACTIVE MOIETY	YZI5105V0L	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
octoxynol-40	INACTIVE INGREDIENT	9T1C662FKS	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
water	INACTIVE INGREDIENT	059QF0KO0R	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-9277	ACULAR LS (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20240704_4fad0873-f79c-4f07-9fac-5060be6b38fe.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACULAR LS	KETOROLAC TROMETHAMINE	Allergan, Inc.	4fad0873-f79c-4f07-9fac-5060be6b38fe	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528 ndc (package): 0023-9277-05 ndc (product): 0023-9277 ndc11 (package): 00023927705
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Pacific Pharma, Inc.	8432a1c5-15e5-4e3d-8e2d-49646e6b7eda	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	A-S Medication Solutions	1580b751-15ff-4193-8f22-25a9a468989a	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021528 application number: NDA021528

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
860105	ACULAR LS 0.4 % Ophthalmic Solution	PSN	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860103	ketorolac tromethamine 0.4 % Ophthalmic Solution	PSN	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860105	ketorolac tromethamine 4 MG/ML Ophthalmic Solution [Acular]	SBD	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860103	ketorolac tromethamine 4 MG/ML Ophthalmic Solution	SCD	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860105	Acular 0.4 % Ophthalmic Solution	SY	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860105	Acular 4 MG/ML Ophthalmic Solution	SY	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860105	Acular LS 0.4 % Ophthalmic Solution	SY	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860105	Acular LS 4 MG/ML Ophthalmic Solution	SY	4fad0873-f79c-4f07-9fac-5060be6b38fe	17
860103	ketorolac tromethamine 0.4 % Ophthalmic Solution	SY	4fad0873-f79c-4f07-9fac-5060be6b38fe	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-9277-05	00023927705	1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER	2003-08-19	0000-00-00	No	No	Current