FDA.reportPublic FDA data

Valproic Acid

Product NDC
70518-0079
11-digit product format
705180079
Labeler code
70518
Product ID
70518-0079_5022b54b-16cb-161b-e063-6294a90a8b07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073484
Marketing category
ANDA
Marketing start
2016-12-23
Substance
VALPROIC ACID
Active strength
250 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valproic Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALPROIC ACID250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii614OI1Z5WI
Rxcui1099681

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
70518-0079-0Valproic Acid30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED3021
70518-0079-1Valproic Acid100 in 1 BOXCAPSULE, LIQUID FILLED10021
70518-0079-2Valproic Acid1 in 1 POUCHCAPSULE, LIQUID FILLED121
70518-0079-3Valproic Acid50 in 1 BOXCAPSULE, LIQUID FILLED5021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0079-0EA - Each70518-00799568b836-1992-40bd-a6d0-4d46fa601c7e12025-12-16
70518-0079-1EA - Each70518-0079755aef45-4b06-4dfe-a434-5b469eeb82ff12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0079VALPROIC ACID CAPSULE, LIQUID FILLED [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 4 package rows20250529_ec41025a-ed7d-48c8-9005-08e3a9417f30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSNec41025a-ed7d-48c8-9005-08e3a9417f3021
1099681valproic acid 250 MG Oral CapsuleSCDec41025a-ed7d-48c8-9005-08e3a9417f3021
1099681VPA 250 MG Oral CapsuleSYec41025a-ed7d-48c8-9005-08e3a9417f3021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0079-07051800790030 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (70518-0079-0) 2016-12-230000-00-00NoNoCurrent
70518-0079-170518007901100 POUCH in 1 BOX (70518-0079-1) / 1 CAPSULE, LIQUID FILLED in 1 POUCH (70518-0079-2) 100 pouch2020-06-110000-00-00NoNoCurrent
70518-0079-2705180079021 in 1 POUCHHistorical
70518-0079-37051800790350 POUCH in 1 BOX (70518-0079-3) / 1 CAPSULE, LIQUID FILLED in 1 POUCH (70518-0079-2) 50 pouch2026-04-23NoNoHistorical