Home NDC 69344-144 Sprix
Product NDC 69344-144
11-digit product format 693440144
Labeler code 69344
Product ID 69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketorolac tromethamine
Dosage form SPRAY, METERED
Route NASAL
Labeler Zyla Life Sciences US LLC
Application NDA022382
Marketing category NDA
Marketing start 2011-04-26
Substance KETOROLAC TROMETHAMINE
Active strength 15.75 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 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base Sprix
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 15.75 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797855 Internal RxNorm lookup 1797857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69344-144-43 Sprix 5 in 1 CARTON SPRAY, METERED 5 14 69344-144-53 Sprix 1 in 1 CARTON SPRAY, METERED 1 14 69344-144-63 Sprix 8 in 1 BOTTLE, SPRAY SPRAY, METERED 8 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69344-144 SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [ZYLA LIFE SCIENCES US LLC] 14 Current NDC, Legacy NDC, 3 package rows 20241207_97005a1c-167e-4676-bae7-e49b38c36f9e.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 ndc (product): 69344-144
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69344-144-43 69344014443 5 CARTON in 1 CARTON (69344-144-43) / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63) 5 carton 2011-04-26 0000-00-00 No No Current 69344-144-53 69344014453 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63) 2022-03-02 0000-00-00 No No Current 69344-144-63 69344014463 8 in 1 BOTTLE, SPRAY Historical