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

Additional Listing Data#

Finished product
Yes
Brand name base
Sprix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE15.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui1797855, 1797857

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69344-144-43Sprix5 in 1 CARTONSPRAY, METERED514
69344-144-53Sprix1 in 1 CARTONSPRAY, METERED114
69344-144-63Sprix8 in 1 BOTTLE, SPRAYSPRAY, METERED814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69344-144-43EA - Each69344-14463a85607-07af-4ce0-8001-442e02a4cf6a12015-10-02
69344-144-63EA - Each69344-14450b9337e-8526-4d39-82df-0f97e7ec5cc712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQSPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1
KETOROLACACTIVE MOIETYYZI5105V0LSPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [EGALET US INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69344-144SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [ZYLA LIFE SCIENCES US LLC]14Current NDC, Legacy NDC, 3 package rows20241207_97005a1c-167e-4676-bae7-e49b38c36f9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797855ketorolac tromethamine 15.75 MG/ACTUAT Metered Dose Nasal SprayPSN97005a1c-167e-4676-bae7-e49b38c36f9e14
1797857SPRIX 15.75 MG/ACTUAT Metered Dose Nasal SprayPSN97005a1c-167e-4676-bae7-e49b38c36f9e14
1797857ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal Spray [Sprix]SBD97005a1c-167e-4676-bae7-e49b38c36f9e14
1797855ketorolac tromethamine 15.8 MG/ACTUAT Metered Dose Nasal SpraySCD97005a1c-167e-4676-bae7-e49b38c36f9e14
1797855ketorolac tromethamine 15.75 MG/ACTUAT Metered Dose Nasal SpraySY97005a1c-167e-4676-bae7-e49b38c36f9e14
1797857Sprix 15.75 MG/ACTUAT Metered Dose Nasal SpraySY97005a1c-167e-4676-bae7-e49b38c36f9e14
1797857Sprix 15.8 MG/ACTUAT Metered Dose Nasal SpraySY97005a1c-167e-4676-bae7-e49b38c36f9e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69344-144-43693440144435 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 carton2011-04-260000-00-00NoNoCurrent
69344-144-53693440144531 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63) 2022-03-020000-00-00NoNoCurrent
69344-144-63693440144638 in 1 BOTTLE, SPRAYHistorical