Sprix

Product NDC: 76519-1017
11-digit product format: 765191017
Labeler code: 76519
Product ID: 76519-1017_70ee2244-de89-4c89-8a23-b23d2843f281
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketorolac tromethamine
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: H.J. Harkins Company, Inc.
Application: NDA022382
Marketing category: NDA
Marketing start: 2011-04-26
Marketing end: 0000-00-00
Substance: KETOROLAC TROMETHAMINE
Active strength: 16 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76519-1017		I	Inactivated by FDA		2026-08-17
excluded package	package	76519-1017	76519-1017-1	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 1 · 44 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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`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	76519-1017-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76519-1017-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76519-1017-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76519-1017-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76519-1017-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76519-1017-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76519-1017-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76519-1017-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76519-1017-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76519-1017-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76519-1017-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	76519-1017-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	76519-1017-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	76519-1017-1	`110d247fa046…`	`a55b01930146…`

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
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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	N022382-001	SPRIX	15.75MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2010-05-14	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
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
76519-1017-1	2019-11-27	C162847	48780-1	9855d018-d8e0-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use SPRIX ® safely and effectively. See full prescribing information for SPRIX. SPRIX ® (ketorolac tromethamine) Nasal Spray Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76519-1017-1	Sprix	1 in 1 BOTTLE, SPRAY	SPRAY, METERED	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ketorolac tromethamine	ACTIVE INGREDIENT	4EVE5946BQ	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1
ketorolac	ACTIVE MOIETY	YZI5105V0L	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76519-1017	SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 1 package rows	20121031_09a80ee7-274a-4f96-8b42-480436896050.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797855	ketorolac tromethamine 15.75 MG/ACTUAT Metered Dose Nasal Spray	PSN	09a80ee7-274a-4f96-8b42-480436896050	1
1797857	SPRIX 15.75 MG/ACTUAT Metered Dose Nasal Spray	PSN	09a80ee7-274a-4f96-8b42-480436896050	1
1797857	ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal Spray [Sprix]	SBD	09a80ee7-274a-4f96-8b42-480436896050	1
1797855	ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal Spray	SCD	09a80ee7-274a-4f96-8b42-480436896050	1
1797855	ketorolac tromethamine 15.75 MG/ACTUAT Metered Dose Nasal Spray	SY	09a80ee7-274a-4f96-8b42-480436896050	1
1797857	Sprix 15.75 MG/ACTUAT Metered Dose Nasal Spray	SY	09a80ee7-274a-4f96-8b42-480436896050	1
1797857	Sprix 15.8 MG/ACTUAT Metered Dose Nasal Spray	SY	09a80ee7-274a-4f96-8b42-480436896050	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
76519-1017-1	76519101701	1 in 1 BOTTLE, SPRAY	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sprix	H.J. Harkins Company, Inc. \| HollisterStier Laboratories LLC \| Sharp Corporation	2012-10-29	HUMAN PRESCRIPTION DRUG LABEL	1