Acular

Product NDC: 0023-2181
11-digit product format: 000232181
Labeler code: 0023
Product ID: 0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA019700
Marketing category: NDA
Marketing start: 1992-12-01
Substance: KETOROLAC TROMETHAMINE
Active strength: 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

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
N019700-001	ACULAR	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N019700-001	AT

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019700-001	ACULAR	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1992-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019700-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019700-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019700-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019700-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019700-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019700-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019700-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019700-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019700-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019700-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019700-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019700-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019700-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019700-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019700-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019700-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019700-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019700-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019700-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019700-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019700-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019700-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019700-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019700-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019700-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019700-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019700-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019700-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019700-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019700-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019700-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019700-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019700-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019700-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019700-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019700-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019700-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019700-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019700-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019700-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	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
860107	Internal RxNorm lookup
860109	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
c94644d3-7b64-4f3d-a0c7-12c77466a0fc	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	Strength	SPL version
0023-2181-05	Acular	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		16
0023-2181-05	Acular	1 in 1 CARTON	SOLUTION/ DROPS	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-2181-05	ML - Milliliter	0023-2181	e8a9d84c-675b-47dc-be8d-6a81a004985b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketorolac Tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
Ketorolac	ACTIVE MOIETY	YZI5105V0L	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
octoxynol-40	INACTIVE INGREDIENT	9T1C662FKS	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
water	INACTIVE INGREDIENT	059QF0KO0R	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	6
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
OCTOXYNOL-40	INACTIVE INGREDIENT	9T1C662FKS	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC]	4
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
OCTOXYNOL-40	INACTIVE INGREDIENT	9T1C662FKS	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-2181	ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20250410_c94644d3-7b64-4f3d-a0c7-12c77466a0fc.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
Acular	KETOROLAC TROMETHAMINE	Allergan, Inc.	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019700 application number: NDA019700 ndc (product): 0023-2181

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
860109	ACULAR 0.5 % Ophthalmic Solution	PSN	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860109	ketorolac tromethamine 5 MG/ML Ophthalmic Solution [Acular]	SBD	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860109	Acular 0.5 % Ophthalmic Solution	SY	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860109	Acular 5 MG/ML Ophthalmic Solution	SY	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	c94644d3-7b64-4f3d-a0c7-12c77466a0fc	16
860109	ACULAR 0.5 % Ophthalmic Solution	PSN	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860109	ketorolac tromethamine 5 MG/ML Ophthalmic Solution [Acular]	SBD	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860109	Acular 0.5 % Ophthalmic Solution	SY	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860109	Acular 5 MG/ML Ophthalmic Solution	SY	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	5ba45168-ad5d-4ea9-bd85-fc2fa2b13dad	4
860109	ACULAR 0.5 % Ophthalmic Solution	PSN	8014fa52-6180-4365-8285-0943a036a6f6	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	8014fa52-6180-4365-8285-0943a036a6f6	1
860109	ketorolac tromethamine 5 MG/ML Ophthalmic Solution [Acular]	SBD	8014fa52-6180-4365-8285-0943a036a6f6	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	8014fa52-6180-4365-8285-0943a036a6f6	1
860109	Acular 0.5 % Ophthalmic Solution	SY	8014fa52-6180-4365-8285-0943a036a6f6	1
860109	Acular 5 MG/ML Ophthalmic Solution	SY	8014fa52-6180-4365-8285-0943a036a6f6	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	8014fa52-6180-4365-8285-0943a036a6f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-2181-05	00023218105	1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER	1992-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acular	Allergan, Inc.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	16
ACULAR ® (ketorolac tromethamine ophthalmic solution) 0.5% sterile	STAT Rx USA LLC \| PSS World Medical Inc.	2012-05-31	HUMAN PRESCRIPTION DRUG LABEL	4
ACULAR - Rebel Distributors Corp.	Rebel Distributors Corp.	2010-09-01	HUMAN PRESCRIPTION DRUG LABEL	1