FDA.reportPublic FDA data

Valproic

Product NDC
71610-906
11-digit product format
716100906
Labeler code
71610
Product ID
71610-906_35d13593-172f-3a08-e063-6294a90a72fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA073229
Marketing category
ANDA
Marketing start
2009-09-08
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-906-30Valproic30 in 1 BOTTLECAPSULE, LIQUID FILLED302
71610-906-53Valproic60 in 1 BOTTLECAPSULE, LIQUID FILLED602
71610-906-60Valproic90 in 1 BOTTLECAPSULE, LIQUID FILLED902
71610-906-70Valproic120 in 1 BOTTLECAPSULE, LIQUID FILLED1202
71610-906-80Valproic180 in 1 BOTTLECAPSULE, LIQUID FILLED1802
71610-906-90Valproic240 in 1 BOTTLECAPSULE, LIQUID FILLED2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-906-30EA - Each71610-906e1b6e180-fc42-4594-a5c6-b34d2e637c6a12025-06-13
71610-906-53EA - Each71610-9068cd735fd-bbc3-4a72-8568-514b99aada4e12025-06-13
71610-906-60EA - Each71610-906dbb25ea3-429b-4825-a379-3afe9f4d4f7312025-06-13
71610-906-70EA - Each71610-906f19b7400-3d6f-4c57-8b76-1399b98378e212025-07-08
71610-906-80EA - Each71610-90646def0a9-a200-430f-bb6f-cbc7d293e3c412025-06-13
71610-906-90EA - Each71610-906038e050a-6775-400a-95a6-832139e53ba512025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-906VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]2Current NDC, 6 package rows20250529_34a0d45a-4388-7d8b-e063-6394a90a6c3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN34a0d45a-4388-7d8b-e063-6394a90a6c3f2
1099681valproic acid 250 MG Oral CapsuleSCD34a0d45a-4388-7d8b-e063-6394a90a6c3f2
1099681VPA 250 MG Oral CapsuleSY34a0d45a-4388-7d8b-e063-6394a90a6c3f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-906-307161009063030 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-30) 2025-05-07NoNoHistorical
71610-906-537161009065360 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-53) 2025-05-07NoNoHistorical
71610-906-607161009066090 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-60) 2025-05-07NoNoHistorical
71610-906-7071610090670120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-70) 2025-05-23NoNoHistorical
71610-906-8071610090680180 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-80) 2025-05-07NoNoHistorical
71610-906-9071610090690240 CAPSULE, LIQUID FILLED in 1 BOTTLE (71610-906-90) 2025-05-23NoNoHistorical