FDA.reportPublic FDA data

valproic acid

Product NDC
0832-0310
11-digit product format
008320310
Labeler code
0832
Product ID
0832-0310_39829040-e2d4-f4ca-e063-6394a90ace84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valproic acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA073229
Marketing category
ANDA
Marketing start
2011-10-29
Marketing end
2027-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
valproic acid

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
0832-0310-11valproic acid100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0310-11EA - Each0832-031075c559d9-a7c6-45d8-94ff-c883e910fc1a12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
valproic acidACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2
valproic acidACTIVE MOIETY614OI1Z5WIVALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LVALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXVALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2
peanut oilINACTIVE INGREDIENT5TL50QU0W4VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPVALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0310VALPROIC ACID CAPSULE [UPSHER-SMITH LABORATORIES, LLC]12Current NDC, Legacy NDC, 1 package rows20230420_7d4df6ad-3d53-4664-9200-749487bf3689.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN7d4df6ad-3d53-4664-9200-749487bf368913
1099681valproic acid 250 MG Oral CapsuleSCD7d4df6ad-3d53-4664-9200-749487bf368913
1099681VPA 250 MG Oral CapsuleSY7d4df6ad-3d53-4664-9200-749487bf368913
1099681valproic acid 250 MG Oral CapsulePSN3904177b-8a26-4356-9080-d2a2e3f468af3
1099681valproic acid 250 MG Oral CapsulePSN8bdbacb1-b38a-3282-e053-2a95a90af0223
1099681valproic acid 250 MG Oral CapsuleSCD3904177b-8a26-4356-9080-d2a2e3f468af3
1099681valproic acid 250 MG Oral CapsuleSCD8bdbacb1-b38a-3282-e053-2a95a90af0223
1099681VPA 250 MG Oral CapsuleSY3904177b-8a26-4356-9080-d2a2e3f468af3
1099681VPA 250 MG Oral CapsuleSY8bdbacb1-b38a-3282-e053-2a95a90af0223
1099681valproic acid 250 MG Oral CapsulePSNdf742f4a-9440-538d-e053-2a95a90a1de61
1099681valproic acid 250 MG Oral CapsuleSCDdf742f4a-9440-538d-e053-2a95a90a1de61
1099681VPA 250 MG Oral CapsuleSYdf742f4a-9440-538d-e053-2a95a90a1de61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0310-1100832031011100 CAPSULE in 1 BOTTLE (0832-0310-11) 100 capsule2015-02-092027-03-31NoNoCurrent