Ketorolac Tromethamine

Product NDC: 12634-809
11-digit product format: 126340809
Labeler code: 12634
Product ID: 12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca, Inc
Application: ANDA074754
Marketing category: ANDA
Marketing start: 2005-10-25
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 10 mg/1
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: 2019-12-31
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 · 18 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-809		I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-00	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-01	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-25	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-55	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-57	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-59	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-60	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-61	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-65	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-66	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-71	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-79	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-80	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-85	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-91	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-95	I	Inactivated by FDA	2026-08-17
excluded package	package	12634-809	12634-809-96	I	Inactivated by FDA	2026-08-17

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 7 · 378 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	12634-809-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-65	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-66	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-809-80	`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	12634-809-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-65	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-66	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-809-80	`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	12634-809-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-65	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-66	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-809-80	`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	12634-809-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-809-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-809-65	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-809-66	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-809-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
A074754-001	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	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
A074754-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB		1997-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`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	A074754-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074754-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074754-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074754-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074754-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074754-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074754-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074754-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074754-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074754-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074754-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074754-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074754-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074754-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074754-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074754-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074754-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074754-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074754-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074754-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074754-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074754-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074754-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074754-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074754-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074754-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074754-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074754-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074754-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074754-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074754-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074754-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074754-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074754-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074754-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074754-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074754-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074754-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074754-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074754-001	AB	1	`e64feba35796…`

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, Related label table
NDC	Related label
12634-809-00	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-01	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-25	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-55	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-57	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-59	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-60	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-61	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-65	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-66	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-71	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-79	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-80	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-85	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-91	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-95	Ketorolac Tromethamine Tablets, USP 10mg
12634-809-96	Ketorolac Tromethamine Tablets, USP 10mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-809-00	Ketorolac Tromethamine	10 in 1 BOTTLE	TABLET	10	2
12634-809-01	Ketorolac Tromethamine	100 in 1 BOTTLE	TABLET	100	2
12634-809-25	Ketorolac Tromethamine	25 in 1 BLISTER PACK	TABLET	25	2
12634-809-55	Ketorolac Tromethamine	15 in 1 BLISTER PACK	TABLET	15	2
12634-809-57	Ketorolac Tromethamine	20 in 1 BLISTER PACK	TABLET	20	2
12634-809-59	Ketorolac Tromethamine	30 in 1 BLISTER PACK	TABLET	30	2
12634-809-60	Ketorolac Tromethamine	60 in 1 BOTTLE	TABLET	60	2
12634-809-61	Ketorolac Tromethamine	10 in 1 BLISTER PACK	TABLET	10	2
12634-809-65	Ketorolac Tromethamine	5 in 1 BLISTER PACK	TABLET	5	2
12634-809-66	Ketorolac Tromethamine	6 in 1 BLISTER PACK	TABLET	6	2
12634-809-71	Ketorolac Tromethamine	30 in 1 BOTTLE	TABLET	30	2
12634-809-79	Ketorolac Tromethamine	25 in 1 BOTTLE	TABLET	25	2
12634-809-80	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET	20	2
12634-809-85	Ketorolac Tromethamine	15 in 1 BOTTLE	TABLET	15	2
12634-809-91	Ketorolac Tromethamine	1 in 1 BLISTER PACK	TABLET	1	2
12634-809-95	Ketorolac Tromethamine	5 in 1 BOTTLE	TABLET	5	2
12634-809-96	Ketorolac Tromethamine	6 in 1 BOTTLE	TABLET	6	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOROLAC TROMETHAMINE	ACTIVE INGREDIENT	4EVE5946BQ	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-809	KETOROLAC TROMETHAMINE TABLET [APOTHECA, INC]	2	Legacy NDC, 17 package rows	20140118_e20df5b6-84da-4715-b36e-bb7e4be55416.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Sportpharm LLC	0749f61d-12e6-4280-8f41-bd4df81e7ae6	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	REMEDYREPACK INC.	f47d4365-40a8-445b-99cd-49edad6a8ffc	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Northwind Health Company, LLC	d17ed469-677b-4a2e-96a9-5cfd0f50ecd9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	American Health Packaging	48244614-53ec-47e6-ad48-50814bdcceb7	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	PD-Rx Pharmaceuticals, Inc.	add10ccd-c205-4512-9619-253290fa1152	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	A-S Medication Solutions	9fdba2e6-969f-4624-b08b-a42f99e4eff9	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Advanced Rx Pharmacy of Tennessee, LLC	c1717245-cef3-b3d7-e053-2a95a90a1ac5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Teva Pharmaceuticals USA, Inc.	688f5dec-a6db-43c6-a1f8-5df99d08d395	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	415a5393-296f-30e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	NuCare Pharmaceuticals, Inc.	46dc8f62-e754-50e3-e054-00144ff8d46c	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Bryant Ranch Prepack	f713500a-20b8-8e20-c4cc-956805170335	2023-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Asclemed USA, Inc.	94c7c57a-fd1e-41ab-bc39-9a538f6011d1	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754
Ketorolac Tromethamine	KETOROLAC TROMETHAMINE	Proficient Rx LP	f5170993-81a9-4eb7-95ac-60697a5ee1d7	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074754 application number: ANDA074754

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	e20df5b6-84da-4715-b36e-bb7e4be55416	2
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	e20df5b6-84da-4715-b36e-bb7e4be55416	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-809-00	12634080900	10 in 1 BOTTLE	Historical
12634-809-01	12634080901	100 in 1 BOTTLE	Historical
12634-809-25	12634080925	25 in 1 BLISTER PACK	Historical
12634-809-55	12634080955	15 in 1 BLISTER PACK	Historical
12634-809-57	12634080957	20 in 1 BLISTER PACK	Historical
12634-809-59	12634080959	30 in 1 BLISTER PACK	Historical
12634-809-60	12634080960	60 in 1 BOTTLE	Historical
12634-809-61	12634080961	10 in 1 BLISTER PACK	Historical
12634-809-65	12634080965	5 in 1 BLISTER PACK	Historical
12634-809-66	12634080966	6 in 1 BLISTER PACK	Historical
12634-809-71	12634080971	30 in 1 BOTTLE	Historical
12634-809-79	12634080979	25 in 1 BOTTLE	Historical
12634-809-80	12634080980	20 in 1 BOTTLE	Historical
12634-809-85	12634080985	15 in 1 BOTTLE	Historical
12634-809-91	12634080991	1 in 1 BLISTER PACK	Historical
12634-809-95	12634080995	5 in 1 BOTTLE	Historical
12634-809-96	12634080996	6 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets, USP 10mg	Apotheca, Inc	2014-01-17	HUMAN PRESCRIPTION DRUG LABEL	2