FDA.reportPublic FDA data

Valproic Acid

Product NDC
17856-0152
11-digit product format
178560152
Labeler code
17856
Product ID
17856-0152_38930d1f-1f70-1fa5-e063-6394a90a5c21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA073484
Marketing category
ANDA
Marketing start
2016-07-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valproic Acid
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0152-12025-03-18C16284748780-1f386c64a-2503-0266-e053-dadaa90a7c1aVALPROIC ACID CAPSULES. These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES. VALPROIC ACID capsules, for oral use Initial U.S. Approval: 1978
17856-0152-12023-01-30C16284748780-1f386c64a-2503-0266-e053-dadaa90a7c1aVALPROIC ACID CAPSULES. These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for VALPROIC ACID CAPSULES. VALPROIC ACID capsules, for oral use Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0152-1Valproic Acid1 in 1 POUCHCAPSULE, LIQUID FILLED13
17856-0152-1Valproic Acid100 in 1 BOX, UNIT-DOSECAPSULE, LIQUID FILLED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0152VALPROIC ACID CAPSULE, LIQUID FILLED [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 2 package rows20250321_453444b6-1f50-49de-ab3c-1e429c83bffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN453444b6-1f50-49de-ab3c-1e429c83bffa3
1099681valproic acid 250 MG Oral CapsuleSCD453444b6-1f50-49de-ab3c-1e429c83bffa3
1099681VPA 250 MG Oral CapsuleSY453444b6-1f50-49de-ab3c-1e429c83bffa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0152-117856015201100 POUCH in 1 BOX, UNIT-DOSE (17856-0152-1) / 1 CAPSULE, LIQUID FILLED in 1 POUCH100 pouch2021-06-250000-00-00NoNoCurrent