FDA.reportPublic FDA data

NDC 63323-494-01 - Valproate Sodium

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
63323-494
Requested NDC
63323-494-01
Package NDCs from labels
63323-494-41, 63323-494-16, 63323-494-01, 63323-494-05
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Valproate Sodium - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-12-15HUMAN PRESCRIPTION DRUG LABEL
Valproate Sodium - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-10-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-494-01Valproate Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION511
63323-494-05Valproate Sodium10 in 1 TRAYINJECTION, SOLUTION1011
63323-494-16Valproate Sodium10 in 1 TRAYINJECTION, SOLUTION106
63323-494-41Valproate Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-494VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20241206_c572ece7-03d3-4c2a-aeb5-61f2023b28ea.zip
63323-494VALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250202_3dfb6da1-f66a-4618-9f74-d2d6c16c0b58.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-494-01ML - Milliliter63323-494cb01972f-e7fc-46b0-a0dd-85a4c9c9459512021-10-08
63323-494-05ML - Milliliter63323-4943162458e-ca01-4267-a70c-560b7739d19112013-02-13
63323-494-16ML - Milliliter63323-494c8bd314b-2a8e-4c42-ad89-4d4b2d151a7a12016-03-04
63323-494-41ML - Milliliter63323-494fb651b95-a1b8-410d-aed1-b26babf14ea012021-10-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROATE SODIUMACTIVE INGREDIENT5VOM6GYJ0DVALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KVALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROATE SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3

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 9 of 11 · 201 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREATINUM, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.2fe2d3c1-1829-4a33-be8e-2bad52546f362023-07-17WarningsExact identifier
unii: QTT17582CB
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Divalproex SodiumDIVALPROEX SODIUMHahnemann Laboratories, INC.f7fec516-ec6f-6248-e053-6294a90a33422023-03-28Exact identifier
unii: 5VOM6GYJ0D
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Acidum MuriaticumACIDUM MURIATICUMHahnemann Laboratories, INC.f2aad04c-5151-6cab-e053-2a95a90ad3a72023-01-19Exact identifier
unii: QTT17582CB
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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