Ketorolac Tromethamine

Product NDC: 63629-2974
11-digit product format: 636292974
Labeler code: 63629
Product ID: 63629-2974_1d9caf46-330d-433f-962e-8da0468be79e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketorolac Tromethamine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074754
Marketing category: ANDA
Marketing start: 1998-06-17
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
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.

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
2025-01-19 17:59 UTC	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A074754-001	KETOROLAC TROMETHAMINE	10MG	TABLET / ORAL	AB	RS	1997-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074754-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A074754-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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	Sportpharm LLC	0749f61d-12e6-4280-8f41-bd4df81e7ae6	2026-04-05	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 ndc (product): 63629-2974
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

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	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
f713500a-20b8-8e20-c4cc-956805170335	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-2974-0	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-1	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-2	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-3	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-4	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-5	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-6	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-7	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-8	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-9	2020-02-25	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-0	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-1	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-2	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-3	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-4	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-5	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-6	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-7	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-8	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only
63629-2974-9	2020-01-31	C162847	48780-1	9d75b9d0-29d1-f424-e053-dadaa90a57ce	Ketorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-2974-0	Ketorolac Tromethamine	3 in 1 BOTTLE	TABLET, FILM COATED	3	9
63629-2974-1	Ketorolac Tromethamine	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
63629-2974-2	Ketorolac Tromethamine	10 in 1 BOTTLE	TABLET, FILM COATED	10	9
63629-2974-3	Ketorolac Tromethamine	20 in 1 BOTTLE	TABLET, FILM COATED	20	9
63629-2974-4	Ketorolac Tromethamine	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
63629-2974-5	Ketorolac Tromethamine	16 in 1 BOTTLE	TABLET, FILM COATED	16	9
63629-2974-6	Ketorolac Tromethamine	8 in 1 BOTTLE	TABLET, FILM COATED	8	9
63629-2974-7	Ketorolac Tromethamine	15 in 1 BOTTLE	TABLET, FILM COATED	15	9
63629-2974-8	Ketorolac Tromethamine	5 in 1 BOTTLE	TABLET, FILM COATED	5	9
63629-2974-9	Ketorolac Tromethamine	100 in 1 BOTTLE	TABLET, FILM COATED	100	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2974-1	EA - Each	63629-2974	6397c33a-5a04-4871-be93-21b6c5a053fa	1	2012-07-24
63629-2974-2	EA - Each	63629-2974	2cd49b80-261e-4664-89ee-f858377795c4	1	2012-07-24
63629-2974-3	EA - Each	63629-2974	216e37ae-185a-46a9-8a0d-4a771cabef67	1	2012-07-24
63629-2974-4	EA - Each	63629-2974	344b0a89-4921-4423-af5b-e02367b8a89c	1	2012-07-24
63629-2974-5	EA - Each	63629-2974	567ce373-8e35-4c37-b0bb-9d25adcd4447	1	2012-07-24
63629-2974-6	EA - Each	63629-2974	cbb255f1-f663-4a34-90c7-4e042526b0b0	1	2012-07-24
63629-2974-7	EA - Each	63629-2974	0f42e9c0-81ce-4017-9416-058cc29bb857	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 [BRYANT RANCH PREPACK]	2
KETOROLAC	ACTIVE MOIETY	YZI5105V0L	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2974	KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	9	Current NDC, Legacy NDC, 10 package rows	20231129_f713500a-20b8-8e20-c4cc-956805170335.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
834022	ketorolac tromethamine 10 MG Oral Tablet	PSN	f713500a-20b8-8e20-c4cc-956805170335	9
834022	ketorolac tromethamine 10 MG Oral Tablet	SCD	f713500a-20b8-8e20-c4cc-956805170335	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2974-0	63629297400	3 TABLET, FILM COATED in 1 BOTTLE (63629-2974-0)	2011-05-09	0000-00-00	No	No	Current
63629-2974-1	63629297401	30 TABLET, FILM COATED in 1 BOTTLE (63629-2974-1)	2009-04-03	0000-00-00	No	No	Current
63629-2974-2	63629297402	10 TABLET, FILM COATED in 1 BOTTLE (63629-2974-2)	2006-03-09	0000-00-00	No	No	Current
63629-2974-3	63629297403	20 TABLET, FILM COATED in 1 BOTTLE (63629-2974-3)	2009-04-03	0000-00-00	No	No	Current
63629-2974-4	63629297404	90 TABLET, FILM COATED in 1 BOTTLE (63629-2974-4)	2014-10-09	0000-00-00	No	No	Current
63629-2974-5	63629297405	16 TABLET, FILM COATED in 1 BOTTLE (63629-2974-5)	2012-03-23	0000-00-00	No	No	Current
63629-2974-6	63629297406	8 TABLET, FILM COATED in 1 BOTTLE (63629-2974-6)	2014-03-31	0000-00-00	No	No	Current
63629-2974-7	63629297407	15 TABLET, FILM COATED in 1 BOTTLE (63629-2974-7)	2010-02-11	0000-00-00	No	No	Current
63629-2974-8	63629297408	5 TABLET, FILM COATED in 1 BOTTLE (63629-2974-8)	2011-04-11	0000-00-00	No	No	Current
63629-2974-9	63629297409	100 TABLET, FILM COATED in 1 BOTTLE (63629-2974-9)	2021-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketorolac Tromethamine Tablets USP, 10 mg Rx only	Bryant Ranch Prepack	2023-11-28	HUMAN PRESCRIPTION DRUG LABEL	9