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 108 of 201 · 4,002 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer MistETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.3abd4d79-3dd0-682a-e063-6294a90a28ef2025-07-25WarningsExact identifier
unii: 3K9958V90M
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: 451W47IQ8X
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: 451W47IQ8X
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aabb047-7277-d9cb-e063-6394a90a92242025-07-24WarningsExact identifier
unii: 3K9958V90M
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d5f51d0-01e9-271c-e053-2995a90a63bc2025-07-24WarningsExact identifier
unii: 451W47IQ8X
BedwettingECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUSNewton Laboratories, Inc.9d6058a0-69dd-66d0-e053-2a95a90a58f82025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: 451W47IQ8X
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: 451W47IQ8X
Smart Care COCONUT BREEZE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.7088fa66-a972-4439-aef3-633808b5eafb2025-07-22WarningsExact identifier
unii: 3K9958V90M
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BiopureHAND SANITIZER SPRAYQuest USA Corp3249f563-7968-e512-e063-6394a90aad522025-07-18WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1c90df-19ee-b249-e063-6394a90af33b2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1cd4ae-4a6e-bfcc-e063-6394a90aad032025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1d0f0b-e330-f674-e063-6394a90aec492025-07-17WarningsExact identifier
unii: 3K9958V90M
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEPD-Rx Pharmaceuticals, Inc.862dd7b7-8ed5-42bf-870e-a45b867402262025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4EVE5946BQ
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLMY IMPORTS USA LLC3a2a1165-b710-3bf6-e063-6294a90a352d2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLMY IMPORTS USA LLC3a2a36bb-c55d-67a0-e063-6294a90a1cf42025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLMY IMPORTS USA LLC3a2a4539-30eb-7451-e063-6294a90a2c222025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLMY IMPORTS USA LLC3a2a4fab-6776-7359-e063-6294a90a85242025-07-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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