Ketorolac Tromethamine

Product NDC: 0378-1134
11-digit product format: 003781134
Labeler code: 0378
Product ID: 0378-1134_a2e96323-5726-45ce-9e73-f143f122b06b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA074761
Marketing category: ANDA
Marketing start: 2013-05-16
Marketing end: 2028-07-31
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
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
A074761-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074761-001	AB

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	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074761-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`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	A074761-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074761-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074761-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074761-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074761-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074761-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074761-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074761-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074761-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074761-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074761-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074761-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074761-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074761-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074761-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074761-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074761-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074761-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074761-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074761-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074761-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074761-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074761-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074761-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074761-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074761-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074761-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074761-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074761-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074761-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074761-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074761-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074761-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074761-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074761-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074761-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074761-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074761-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074761-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074761-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ketorolac Tromethamine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOROLAC TROMETHAMINE	10 mg/1

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
834022	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
2837a082-3a34-6f81-5e43-45a70295686b	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
0378-1134-01	Ketorolac Tromethamine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1134-01	EA - Each	0378-1134	c08b8527-ff6f-4563-bbcd-685c14aae423	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 TABLET, FILM COATED [READYMEDS]	5
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [READYMEDS]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	5
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC TROMETHAMINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOTOLAC TROMETHAMINE TABLET, FILM COATED [STAT RX USA LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	KETOROLAC (KETOROLAC TROMETHAMINE) TABLET, FILM COATED [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1134	KETOROLAC TROMETHAMINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 1 package rows	20241004_2837a082-3a34-6f81-5e43-45a70295686b.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
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Mylan Pharmaceuticals Inc.	2837a082-3a34-6f81-5e43-45a70295686b	2024-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074761 application number: ANDA074761 ndc (product): 0378-1134

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
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	2837a082-3a34-6f81-5e43-45a70295686b	16
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2837a082-3a34-6f81-5e43-45a70295686b	16
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	2f4057b1-4707-4975-949e-3d62133d96f9	5
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	2f4057b1-4707-4975-949e-3d62133d96f9	5
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	bc2f7fc4-698e-1286-e053-2a95a90a188e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	bc2f7fc4-698e-1286-e053-2a95a90a188e	3
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	a41b9710-a1ec-41be-8417-b03c5d802ae2	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	dce94664-7e3d-4592-86ac-2a94231e484b	1
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	e61ae711-e6d2-44e4-b7d7-943a9d06f985	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	a41b9710-a1ec-41be-8417-b03c5d802ae2	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	dce94664-7e3d-4592-86ac-2a94231e484b	1
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	e61ae711-e6d2-44e4-b7d7-943a9d06f985	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1134-01	00378113401	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01)	2013-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets, USP 10 mg	Mylan Pharmaceuticals Inc.	2024-08-31	HUMAN PRESCRIPTION DRUG LABEL	17
Ketorolac 10mg tabs	RedPharm Drug, Inc. \| RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	3
Ketorolac Tromethamine - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2022-03-07	HUMAN PRESCRIPTION DRUG LABEL	12
Ketorolac Tromethamine - Bryant Ranch Prepack	Bryant Ranch Prepack	2021-12-20	HUMAN PRESCRIPTION DRUG LABEL	100
Ketorolac Tromethamine - ReadyMeds	ReadyMeds	2014-05-15	HUMAN PRESCRIPTION DRUG LABEL	5
KETOTOLAC TROMETHAMINE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-04-11	HUMAN PRESCRIPTION DRUG LABEL	1
KETOROLAC - STAT RX USA LLC	STAT RX USA LLC	2011-08-16	HUMAN PRESCRIPTION DRUG LABEL	1
Ketorolac Tromethamine - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-03-17	HUMAN PRESCRIPTION DRUG LABEL	1