FDA.reportPublic FDA data

Valproate Sodium

Product NDC
0143-9637
11-digit product format
001439637
Labeler code
0143
Product ID
0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproate Sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078523
Marketing category
ANDA
Marketing start
2013-04-15
Substance
VALPROATE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valproate Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALPROATE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5VOM6GYJ0D
Rxcui1099648

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9637-01Valproate Sodium5 mL in 1 VIAL, SINGLE-DOSEINJECTION57
0143-9637-10Valproate Sodium10 in 1 TRAYINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9637-01ML - Milliliter0143-963767268339-f5ad-4a39-b92b-115ff3b9644c12013-09-04
0143-9637-10ML - Milliliter0143-963700bfba83-6ae6-4dd8-8e26-ce16ce8d52b812013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROATE SODIUMACTIVE INGREDIENT5VOM6GYJ0DVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RVALPROATE SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9637VALPROATE SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20231121_7a687b2f-246d-4736-a20c-92421c263268.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099648valproic acid 500 MG in 5 ML InjectionPSN7a687b2f-246d-4736-a20c-92421c2632687
10996485 ML valproic acid 100 MG/ML InjectionSCD7a687b2f-246d-4736-a20c-92421c2632687
10996485 ML VPA 100 MG/ML InjectionSY7a687b2f-246d-4736-a20c-92421c2632687
1099648valproic acid 500 MG per 5 ML InjectionSY7a687b2f-246d-4736-a20c-92421c2632687

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9637-01001439637015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
0143-9637-100014396371010 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01) 2013-04-150000-00-00NoNoCurrent