Ketorolac Tromethamine

Product NDC: 66993-193
Requested package NDC: 66993-193-95
11-digit product format: 669930193
Labeler code: 66993
Product ID: 66993-193_521d9207-50ed-4c8e-85af-b3e184280231
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Prasco Laboratories
Application: NDA022382
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-08-04
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 16 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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66993-193	66993-193-95	D	Discontinued by firm		2026-09-14

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 1 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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

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
N022382-001	SPRIX	KETOROLAC TROMETHAMINE	15.75MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2010-05-14

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`f41ea6bd6efb…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-193-83	EA - Each	66993-193	0d6d3071-4c30-40c8-870c-72261c6502fc	1	2020-03-10
66993-193-95	EA - Each	66993-193	5997c919-e943-429f-8397-5cce1f9ab8f5	1	2020-03-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sprix	KETOROLAC TROMETHAMINE	Zyla Life Sciences US LLC	97005a1c-167e-4676-bae7-e49b38c36f9e	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022382 application number: NDA022382

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4EVE5946BQ	KETOROLAC TROMETHAMINE	74103-07-4	KETOROLAC TROMETHAMINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-193-95	66993019395	5 BOTTLE, SPRAY in 1 CARTON (66993-193-95) > 1 BOTTLE, UNIT-DOSE in 1 BOTTLE, SPRAY (66993-193-83) > 8 SPRAY, METERED in 1 BOTTLE, UNIT-DOSE	2020-08-04	0000-00-00	No	No	Current