KETOROLAC TROMETHAMINE

Product NDC: 61314-126
11-digit product format: 613140126
Labeler code: 61314
Product ID: 61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA076583
Marketing category: ANDA
Marketing start: 2009-11-05
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 42.

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
A076583-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076583-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076583-001	KETOROLAC TROMETHAMINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-11-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076583-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076583-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076583-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076583-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076583-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076583-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076583-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076583-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076583-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076583-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076583-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076583-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076583-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076583-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076583-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076583-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076583-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076583-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076583-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076583-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076583-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076583-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076583-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076583-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076583-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076583-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076583-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076583-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076583-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076583-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076583-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076583-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076583-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076583-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076583-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076583-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076583-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076583-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076583-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076583-001	AT	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: KETOROLAC TROMETHAMINE
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860107	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
79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
84b851da-be59-d750-14d1-e4d93cc3b4da	Product name	9	20250630
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
6a38bd75-79e3-96c0-1204-08a0282902ae	Product name	4	20250128
4d6e22a5-3693-6edf-0179-2ab93aecbadb	Product name	9	20240724
2194a6ab-15bb-de49-cced-f09e642b1b64	Product name	8	20240313
03452e68-2506-686e-a908-f2381c778fc6	Product name	5	20240307
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
bb41bc3a-c643-93c9-055f-a8f48f363af3	Product name	2	20190219
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61314-126-05	KETOROLAC TROMETHAMINE	1 in 1 CARTON	SOLUTION	1	9
61314-126-05	KETOROLAC TROMETHAMINE	5 mL in 1 BOTTLE	SOLUTION	5	9
61314-126-10	KETOROLAC TROMETHAMINE	1 in 1 CARTON	SOLUTION	1	9
61314-126-10	KETOROLAC TROMETHAMINE	10 mL in 1 BOTTLE	SOLUTION	10	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-126-05	ML - Milliliter	61314-126	f4fb4671-d063-4c4d-aec0-6375e56e8f44	1	2012-07-24
61314-126-10	ML - Milliliter	61314-126	432b55f9-20ea-4307-873d-9d0c70b80b5a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
KETOROLAC TROMETHAMINE	ACTIVE MOIETY	4EVE5946BQ	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-126	KETOROLAC TROMETHAMINE SOLUTION [SANDOZ INC]	8	Current NDC, Legacy NDC, 4 package rows	20220212_79e29a86-1b44-4d95-8d84-5a2e8f23ddcf.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Sandoz Inc	79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076583 application number: ANDA076583 ndc (product): 61314-126
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	ae2e626c-0019-7c4e-e053-2995a90a23be	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076583 application number: ANDA076583
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	A-S Medication Solutions	a1ebb51e-4658-4852-bf90-1983a3d44783	2023-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076583 application number: ANDA076583
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	Proficient Rx LP	c4598ce4-41fb-4cc9-8102-3a66a9bfa36a	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076583 application number: ANDA076583

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
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	a1ebb51e-4658-4852-bf90-1983a3d44783	14
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	a1ebb51e-4658-4852-bf90-1983a3d44783	14
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	a1ebb51e-4658-4852-bf90-1983a3d44783	14
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	9
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	9
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	79e29a86-1b44-4d95-8d84-5a2e8f23ddcf	9
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	c4598ce4-41fb-4cc9-8102-3a66a9bfa36a	4
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	c4598ce4-41fb-4cc9-8102-3a66a9bfa36a	4
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	c4598ce4-41fb-4cc9-8102-3a66a9bfa36a	4
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	ae2e626c-0019-7c4e-e053-2995a90a23be	3
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	ae2e626c-0019-7c4e-e053-2995a90a23be	3
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	ae2e626c-0019-7c4e-e053-2995a90a23be	3
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	ca7a8de8-9185-e89f-e053-2995a90a5e04	2
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	2f2bc309-6da3-4e44-92ce-aff2854bab61	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	PSN	1fc22064-3f54-97c7-e063-6294a90abf0e	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	2f2bc309-6da3-4e44-92ce-aff2854bab61	1
860107	ketorolac tromethamine 5 MG/ML Ophthalmic Solution	SCD	1fc22064-3f54-97c7-e063-6294a90abf0e	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	2f2bc309-6da3-4e44-92ce-aff2854bab61	1
860107	ketorolac tromethamine 0.5 % Ophthalmic Solution	SY	1fc22064-3f54-97c7-e063-6294a90abf0e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-126-05	61314012605	1 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLE	1 bottle	2009-11-05	0000-00-00	No	No	Current
61314-126-10	61314012610	1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE	1 bottle	2009-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOROLAC TROMETHAMINE	Sandoz Inc	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	9
KETOROLAC TROMETHAMINE	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
KETOROLAC TROMETHAMINE	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL	14
KETOROLAC TROMETHAMINE	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	4
KETOROLAC TROMETHAMINE	Preferred Pharmaceuticals, Inc.	2022-07-11	HUMAN PRESCRIPTION DRUG LABEL	4
KETOROLAC TROMETHAMINE	RPK Pharmaceuticals, Inc.	2022-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
IXOBA M	Brisk Pharmaceuticals, Inc. \| Unit Dose Solutions, Inc	2021-11-03	HUMAN PRESCRIPTION DRUG LABEL	2