FDA.reportPublic FDA data

NDC 69344-144-63 - Sprix

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69344-144
Requested NDC
69344-144-63
Package NDCs from labels
69344-144-63, 69344-144-53, 69344-144-43
Manufacturer
Zyla Life Sciences US LLC
Effective date
2024-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sprix - Zyla Life Sciences US LLCZyla Life Sciences US LLC2024-12-05HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 17 · 332 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ketorolac tromethamineKETOROLAC TROMETHAMINESportpharm LLC2a23b0fa-803c-4abb-b588-12cfe83326a92026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.6f727e1f-2838-427b-a236-eeb0101b08f32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEREMEDYREPACK INC.cdd4d548-33f8-42d6-8eae-e36aa577c0502026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.04d5114e-332b-4ed0-85df-b276c1dc296c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINECardinal Health 107, LLC6758cb38-dec8-468f-94e2-613772e39b9a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINERedpharm Drug59d86768-6214-8389-e063-6394a90a0a3d2026-08-25Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEHF Acquisition Co LLC, DBA HealthFirst54dec321-b4c9-f0d6-e063-6294a90ae2312026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ketorolac tromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerisyn LLC5734e81e-2471-1314-e063-6294a90ac9fe2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ketorolac TromethamineKETOROLAC TROMETHAMINEHospira, Inc.8accbb78-fc64-45d5-69b0-35c23a1d2a2e2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.