KETOROLAC TROMETHAMINE

Product NDC: 64679-758
11-digit product format: 646790758
Labeler code: 64679
Product ID: 64679-758_4da5de82-338e-4a91-9b1d-6ee07b04000b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: KETOROLAC TROMETHAMINE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Wockhardt USA LLC.
Application: ANDA077942
Marketing category: ANDA
Marketing start: 2007-03-27
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 30 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-758		D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-01	D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-02	D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-03	D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-04	D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-05	D	Discontinued by firm	2026-10-05
excluded package	package	64679-758	64679-758-06	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 105 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-758-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-758-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-758-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-758-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-758-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-758-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-758-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-758-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-758-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-758-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-758-02	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077942-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP		2007-03-27
A077942-002	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP		2007-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077942-001	AP
A077942-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077942-001	KETOROLAC TROMETHAMINE	15MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077942-002	KETOROLAC TROMETHAMINE	30MG/ML	INJECTABLE / INJECTION	AP	2007-03-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077942-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077942-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077942-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077942-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077942-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077942-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077942-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077942-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077942-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077942-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077942-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077942-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077942-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077942-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077942-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077942-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077942-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077942-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077942-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077942-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077942-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077942-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077942-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077942-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077942-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077942-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077942-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077942-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077942-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077942-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077942-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077942-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077942-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077942-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077942-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077942-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077942-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077942-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077942-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077942-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-758-01	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-02	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-03	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-04	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-05	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-06	2025-12-23	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-01	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-02	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-03	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-04	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-05	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY
64679-758-06	2023-01-30	KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-758-01	ML - Milliliter	64679-758	b7b9d4a6-5b92-4128-8fa4-5e97510ecd5f	1	2012-07-24
64679-758-02	ML - Milliliter	64679-758	a63eba44-736c-4f05-bc5f-cad77646df23	1	2012-07-24
64679-758-04	ML - Milliliter	64679-758	0da6720d-cf6e-45b8-8f47-db11ea207ea7	1	2012-07-24
64679-758-06	ML - Milliliter	64679-758	e17fad4a-ccdf-43ef-bc33-ddf03c1b3ca2	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 INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC]	1
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-758	KETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC.]	4	Legacy NDC	20210515_b4b2ee9a-f59d-4c2f-878c-04a870e2a369.zip

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
1665459	ketorolac tromethamine 60 MG in 2 ML Injection	PSN	63b51e87-a223-4d62-b94e-60adf4872376	2
1665459	2 ML ketorolac tromethamine 30 MG/ML Injection	SCD	63b51e87-a223-4d62-b94e-60adf4872376	2
1665459	ketorolac tromethamine 60 MG per 2 ML Injection	SY	63b51e87-a223-4d62-b94e-60adf4872376	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64679-758-01	64679075801	25 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-01) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11)	2007-03-27	0000-00-00	No	No	Current
64679-758-02	64679075802	25 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-02) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10)	2007-03-27	0000-00-00	No	No	Current
64679-758-03	64679075803	15 VIAL, MULTI-DOSE in 1 CARTON (64679-758-03) > 10 mL in 1 VIAL, MULTI-DOSE	2007-03-27	0000-00-00	No	No	Current
64679-758-04	64679075804	10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11)	2007-03-27	0000-00-00	No	No	Current
64679-758-05	64679075805	1 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-05) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10)	2007-03-27	0000-00-00	No	No	Current
64679-758-06	64679075806	10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-06) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10)	2007-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOROLAC TROMETHAMINE INJECTION, USP Rx ONLY	Wockhardt USA LLC. \| Wockhardt Limited	2021-03-26	HUMAN PRESCRIPTION DRUG LABEL	4
KETOROLAC TROMETHAMINE INJECTION USP	Physicians Total Care, Inc.	2011-12-29	HUMAN PRESCRIPTION DRUG LABEL	2