Valproic

Product NDC
0591-4012
11-digit product format
005914012
Labeler code
0591
Product ID
0591-4012_a64ec7af-329d-4b8c-ad44-eedb68ec8f40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Actavis Pharma, Inc.
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
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
0591-4012-01Valproic100 in 1 BOTTLECAPSULE, LIQUID FILLED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4012-01EA - Each0591-401216d18826-a5bb-409f-93e7-d08cf218559312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]7
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
GELATININACTIVE INGREDIENT2G86QN327LVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4012VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 1 package rows20241030_cef3e335-5891-412f-89c4-79fcd2f145b7.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
1099681valproic acid 250 MG Oral CapsulePSN31ae5a24-a6a9-4103-acda-b6113052b3861
1099681valproic acid 250 MG Oral CapsulePSN86dd50d5-4890-4b3c-8681-18796eff97b61
1099681valproic acid 250 MG Oral CapsulePSN9fbfe4dc-c4df-4911-a440-099c860cb9231
1099681valproic acid 250 MG Oral CapsuleSCD31ae5a24-a6a9-4103-acda-b6113052b3861
1099681valproic acid 250 MG Oral CapsuleSCD86dd50d5-4890-4b3c-8681-18796eff97b61
1099681valproic acid 250 MG Oral CapsuleSCD9fbfe4dc-c4df-4911-a440-099c860cb9231
1099681VPA 250 MG Oral CapsuleSY31ae5a24-a6a9-4103-acda-b6113052b3861
1099681VPA 250 MG Oral CapsuleSY86dd50d5-4890-4b3c-8681-18796eff97b61
1099681VPA 250 MG Oral CapsuleSY9fbfe4dc-c4df-4911-a440-099c860cb9231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-4012-0100591401201100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-4012-01) 2009-09-080000-00-00NoNoCurrent