FDA.reportPublic FDA data

NDC 0641-6041-01 - 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
0641-6041
Requested NDC
0641-6041-01
Package NDCs from labels
0641-6041-01, 0641-6041-25
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 Injection, USPGeneral Injectables and Vaccines, Inc.2018-07-02HUMAN 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
0641-6041-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION113
0641-6041-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6041KETOROLAC 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
0641-6041-01ML - Milliliter0641-6041de1e773b-19d1-4632-93ac-345ac50a144912013-02-13
0641-6041-25ML - Milliliter0641-6041ad136187-25b4-4f4d-ab41-60a269c4d8cb12013-02-13

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 181 of 197 · 3,923 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peppermint Hand Sanitizer GirlALCOHOLK7 Design Group Inc.acd5e0b4-97e5-4a19-94dc-d4f931696d452023-10-25WarningsExact identifier
unii: 3K9958V90M
cheerful choco orange hand sanitizerALCOHOLTarget Corporation7eea44b5-ee6b-448f-a0ae-5da73841f1422023-10-25WarningsExact identifier
unii: 3K9958V90M
Lemonade Hand Sanitizer BoyALCOHOLK7 Design Group Inc.9e07eb49-ebeb-47cd-b86a-5f1618a3d3ef2023-10-25WarningsExact identifier
unii: 3K9958V90M
candy cutie hand sanitizerALCOHOLTarget Corporation920d0dc5-2803-4a25-8f1f-86d7ff61c5682023-10-25WarningsExact identifier
unii: 3K9958V90M
Cherry Hand Sanitizer BoyALCOHOLK7 Design Group Inc.86624b99-65c6-45c0-bbee-49ee56d823eb2023-10-25WarningsExact identifier
unii: 3K9958V90M
creamy cappuccino hand sanitizerALCOHOLTarget Corporationccecdc9e-4a59-4a02-bd82-699af9ed5e972023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGordon Industriese4846d7b-767b-41dd-ab49-dfc3d851f3e62023-10-25WarningsExact identifier
unii: 3K9958V90M
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
G and H Protect Hand SanitizerALCOHOLAccess Business Group LLCe00a87bd-899c-4595-9263-73bb62595a572023-10-23WarningsExact identifier
unii: 3K9958V90M
Jianerkang Sanitizing WipeALCOHOLJianerkang Medical Co., Ltda49b06b6-568b-05b1-e053-2995a90af1422023-10-23WarningsExact identifier
unii: 3K9958V90M
Jianerkang WipesALCOHOLJianerkang Medical Co., Ltda49afe9a-3eaa-401b-e053-2995a90a92452023-10-23WarningsExact identifier
unii: 3K9958V90M
Instant Hand Sanitizer STERILE 70 Ethyl AlcoholALCOHOLJianerkang Medical Co., Ltdaf854c92-12e9-f608-e053-2a95a90ae8f62023-10-23WarningsExact identifier
unii: 3K9958V90M
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
GENUINE FIRST AID Antiseptic Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.d25f02f1-268c-44d8-9a55-c6efcbe8eed12023-10-19WarningsExact identifier
unii: 3K9958V90M
Brompton and Langley Moisturizing Hand Sanitizer Lavnder VanillaALCOHOLGanzhou Olivee Cosmetic Co., Ltd.90bd3436-a8bc-4c19-a300-d59236a8de272023-10-19WarningsExact identifier
unii: 3K9958V90M
Decon Hand Instant Hand SanitizerALCOHOLVeltek Associates, Inc.b0fb3d45-a5c9-4d3c-a840-1b7564ecb3f82023-10-15WarningsExact identifier
unii: 3K9958V90M
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
unii: 3K9958V90M
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
unii: 3K9958V90M
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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