Ketorolac Tromethamine

Product NDC: 63323-161
11-digit product format: 633230161
Labeler code: 63323
Product ID: 63323-161_2b1c6066-d9e0-40a0-ade5-776fc35a3626
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: KETOROLAC TROMETHAMINE
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA075784
Marketing category: ANDA
Marketing start: 2001-09-05
Substance: KETOROLAC TROMETHAMINE
Active strength: 15 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075784-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2002-01-11
A075784-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2002-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075784-001	AP
A075784-002	AP

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075784-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075784-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2002-01-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075784-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075784-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075784-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075784-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075784-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075784-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075784-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075784-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075784-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075784-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075784-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075784-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075784-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075784-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075784-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075784-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075784-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075784-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075784-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075784-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075784-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075784-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075784-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075784-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075784-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075784-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075784-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075784-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075784-002	AP	1	`782e0a99824c…`

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	15 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860092	Internal RxNorm lookup
1665459	Internal RxNorm lookup
1665461	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
ccf905ca-e164-4779-9485-2d139c821bad	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
63323-161-00	Ketorolac Tromethamine	1 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1	8
63323-161-01	Ketorolac Tromethamine	25 in 1 TRAY	INJECTION, SOLUTION	25	8
63323-161-12	Ketorolac Tromethamine	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-161-21	Ketorolac Tromethamine	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	6
63323-161-16	Ketorolac Tromethamine	25 in 1 TRAY	INJECTION, SOLUTION	25	5
63323-161-41	Ketorolac Tromethamine	1 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-161-00	ML - Milliliter	63323-161	61dcf0f8-fd19-497d-9277-b6447e4192a7	1	2022-05-04
63323-161-01	ML - Milliliter	63323-161	ac8552e4-7cfd-461a-880d-7b7d6c8a66e3	1	2013-02-13
63323-161-12	ML - Milliliter	63323-161	71f9d249-0b8f-410c-aaaa-c25d55483ed1	1	2015-03-03
63323-161-16	ML - Milliliter	63323-161	f17ba35e-5041-4395-a4ab-3c9153216ff0	1	2015-12-02
63323-161-21	ML - Milliliter	63323-161	fc69bd60-df92-422a-a9b2-bde63582336a	1	2022-05-04
63323-161-41	ML - Milliliter	63323-161	e74ed780-a563-41d0-83b3-a20626672932	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-161	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240730_d1920335-8e45-4960-b6e9-e6f1f9e6820c.zip
63323-161	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	6	Current NDC, Legacy NDC, 2 package rows	20221208_950b7295-3f68-4027-ac2b-2f7d0f5f8ef9.zip
63323-161	KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	5	Current NDC, Legacy NDC, 2 package rows	20221117_ccf905ca-e164-4779-9485-2d139c821bad.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	e46ebc7f-584e-e2b7-e053-2995a90ad17b	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	HF Acquisition Co LLC, DBA HealthFirst	54dec321-b4c9-f0d6-e063-6294a90ae231	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	f335a030-ffa8-4f42-8166-2f06e036b40d	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	63b73913-246d-4e5b-bdc9-c202980d8777	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Cardinal Health 107, LLC	6758cb38-dec8-468f-94e2-613772e39b9a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	d1920335-8e45-4960-b6e9-e6f1f9e6820c	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-161
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Medical Purchasing Solutions, LLC	9e3ddc51-b572-8fe9-e053-2995a90a2f2a	2023-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	2022-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-161
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Fresenius Kabi USA, LLC	ccf905ca-e164-4779-9485-2d139c821bad	2022-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075784 application number: ANDA075784 ndc (product): 63323-161

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
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	6758cb38-dec8-468f-94e2-613772e39b9a	9
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	6758cb38-dec8-468f-94e2-613772e39b9a	9
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	6758cb38-dec8-468f-94e2-613772e39b9a	9
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	d1920335-8e45-4960-b6e9-e6f1f9e6820c	8
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	950b7295-3f68-4027-ac2b-2f7d0f5f8ef9	6
860092	ketorolac tromethamine 15 MG in 1 ML Injection	PSN	ccf905ca-e164-4779-9485-2d139c821bad	5
1665461	ketorolac tromethamine 30 MG in 1 ML Injection	PSN	ccf905ca-e164-4779-9485-2d139c821bad	5
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	ccf905ca-e164-4779-9485-2d139c821bad	5
860092	1 ML ketorolac tromethamine 15 MG/ML Injection	SCD	ccf905ca-e164-4779-9485-2d139c821bad	5
1665461	1 ML ketorolac tromethamine 30 MG/ML Injection	SCD	ccf905ca-e164-4779-9485-2d139c821bad	5
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	ccf905ca-e164-4779-9485-2d139c821bad	5
860092	ketorolac tromethamine 15 MG per 1 ML Injection	SY	ccf905ca-e164-4779-9485-2d139c821bad	5
1665461	ketorolac tromethamine 30 MG per 1 ML Injection	SY	ccf905ca-e164-4779-9485-2d139c821bad	5
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	ccf905ca-e164-4779-9485-2d139c821bad	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-161-00	63323016100	1 mL in 1 VIAL, SINGLE-USE	1 ml					Historical
63323-161-01	63323016101	25 VIAL, SINGLE-USE in 1 TRAY (63323-161-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-00)		2001-09-05	0000-00-00	No	No	Current
63323-161-12	63323016112	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21)		2001-09-05	0000-00-00	No	No	Current
63323-161-16	63323016116	25 VIAL, SINGLE-USE in 1 TRAY (63323-161-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-41)		2001-09-05	0000-00-00	No	No	Current
63323-161-21	63323016121	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-161-41	63323016141	1 mL in 1 VIAL, SINGLE-USE	1 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Injection, USP	Cardinal Health 107, LLC	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9
Ketorolac Tromethamine Injection, USP	Fresenius Kabi USA, LLC	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	8
Ketorolac Tromethamine Injection, USP	Fresenius Kabi USA, LLC	2022-11-18	HUMAN PRESCRIPTION DRUG LABEL	6
Ketorolac Tromethamine Injection, USP	Fresenius Kabi USA, LLC	2022-09-15	HUMAN PRESCRIPTION DRUG LABEL	5