FDA.reportPublic FDA data

Valproate Sodium

Product NDC
25021-797
11-digit product format
250210797
Labeler code
25021
Product ID
25021-797_bac93779-c94f-49e9-90b7-5a53739b47be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproate Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA076295
Marketing category
ANDA
Marketing start
2024-12-01
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
25021-797-05Valproate Sodium10 in 1 CARTONINJECTION, SOLUTION102
25021-797-05Valproate Sodium5 mL in 1 VIALINJECTION, SOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-797-05ML - Milliliter25021-79756e55a02-5dde-4bab-9264-f52f9e19444312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-797VALPROATE SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20241202_8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099648valproic acid 500 MG in 5 ML InjectionPSN8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad2
10996485 ML valproic acid 100 MG/ML InjectionSCD8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad2
10996485 ML VPA 100 MG/ML InjectionSY8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad2
1099648valproic acid 500 MG per 5 ML InjectionSY8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-797-052502107970510 VIAL in 1 CARTON (25021-797-05) / 5 mL in 1 VIAL10 vial2024-12-01NoNoHistorical