FDA.reportPublic FDA data

NDC 0641-6043-01 - Ketorolac Tromethamine

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
0641-6043
Requested NDC
0641-6043-01
Package NDCs from labels
0641-6043-01, 0641-6043-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketorolac Tromethamine - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-10HUMAN PRESCRIPTION DRUG LABEL
Ketorolac Tromethamine - A-S Medication SolutionsA-S Medication Solutions2021-06-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6043-01Ketorolac Tromethamine2 mL in 1 VIALINJECTION213
0641-6043-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6043KETOROLAC TROMETHAMINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 2 package rows20240411_0c2c75c9-ed7b-46a8-9543-429bf2d8f090.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6043-01ML - Milliliter0641-604336c45488-a54c-43b3-84ee-8e73c00410a912013-02-13
0641-6043-25ML - Milliliter0641-60432417a382-ad3f-43d9-af6d-fd60b4dd63a712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]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 72 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPA HAND SANITIZER CHAMPAGNE BLASHETHYL ALCOHOLRejoice International Corp.47c5e9af-4ea8-fb39-e063-6394a90aa5ab2026-01-06WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLBPI Labs, LLC314b1dab-8f4f-49ae-a105-f974842818b82026-01-05Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Watermelon ScentedALCOHOLFOURSTAR GROUP USA, INC.74176b95-7899-47c7-a330-87f603aa12f52026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Cucumber Mint ScentedALCOHOLFOURSTAR GROUP USA, INC.437cb27e-4a42-4f36-ae0a-9e456055a1832026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Dragon Fruit Bloom ScentedALCOHOLFourstar Group USA, Inc.4e256c4a-6b58-4011-80f5-51d7527943de2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Sandstone Mist ScentedALCOHOLFourstar Group USA, Inc.a9809d18-48c9-483b-bba4-5e9257533d1f2026-01-05WarningsExact identifier
unii: 3K9958V90M
B Pure Moisturizing Hand Sanitizer Pistachio Grove ScentedALCOHOLFourstar Group USA, Inc.8f6ac5e0-822a-4279-be62-e7fc3da161cd2026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Lemon LimeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeaae9-740d-a28a-e063-6294a90a64602026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeeef9-0eed-e7d0-e063-6394a90a6d312026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af27a7-3df9-270a-e063-6394a90abc7d2026-01-05WarningsExact identifier
unii: 3K9958V90M
Hand SanitiserALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a44d82bf-68a3-56bc-e053-2995a90ae5262026-01-05WarningsExact identifier
unii: 3K9958V90M
Green Island SanitiserALCOHOLZhejiang Guoyao Aerosol Co., Ltda7d1df16-3566-badf-e053-2a95a90aa61a2026-01-05WarningsExact identifier
unii: 3K9958V90M
Green IslandETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a7443a72-6ee5-07f7-e053-2995a90a33412026-01-05WarningsExact identifier
unii: 3K9958V90M
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8bc5da3-8660-6343-e053-2995a90ac9052026-01-05WarningsExact identifier
unii: 3K9958V90M
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8c0c9ce-05ac-0f33-e053-2a95a90ab8ed2026-01-05WarningsExact identifier
unii: 3K9958V90M
H2OneETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bcecf7-7767-69b4-e053-2995a90a92472026-01-05WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af97d6-ae84-adfe-e063-6394a90aa7772026-01-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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