FDA.reportPublic FDA data

Valproic Acid

Product NDC
67046-807
11-digit product format
670460807
Labeler code
67046
Product ID
67046-807_59b3262c-a564-ccd1-e053-2991aa0a46c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA073484
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
67046-807-072022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-142022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-152022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-202022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-212022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-282022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-302022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978
67046-807-602022-01-28C16284748780-1d6a99b39-e9b3-a426-e053-dadaa90af4c2807 Valproic Acid 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, USP for oral use USP Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-807-07Valproic Acid7 in 1 BLISTER PACKCAPSULE, LIQUID FILLED71
67046-807-14Valproic Acid14 in 1 BLISTER PACKCAPSULE, LIQUID FILLED141
67046-807-15Valproic Acid15 in 1 BLISTER PACKCAPSULE, LIQUID FILLED151
67046-807-20Valproic Acid20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED201
67046-807-21Valproic Acid21 in 1 BLISTER PACKCAPSULE, LIQUID FILLED211
67046-807-28Valproic Acid28 in 1 BLISTER PACKCAPSULE, LIQUID FILLED281
67046-807-30Valproic Acid30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED301
67046-807-60Valproic Acid60 in 1 BLISTER PACKCAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-807VALPROIC ACID CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b3262c-a563-ccd1-e053-2991aa0a46c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN59b3262c-a563-ccd1-e053-2991aa0a46c61
1099681valproic acid 250 MG Oral CapsuleSCD59b3262c-a563-ccd1-e053-2991aa0a46c61
1099681VPA 250 MG Oral CapsuleSY59b3262c-a563-ccd1-e053-2991aa0a46c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-807-07670460807077 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-07) 2017-09-210000-00-00NoNoCurrent
67046-807-146704608071414 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-14) 2017-09-210000-00-00NoNoCurrent
67046-807-156704608071515 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-15) 2017-09-210000-00-00NoNoCurrent
67046-807-206704608072020 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-20) 2017-09-210000-00-00NoNoCurrent
67046-807-216704608072121 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-21) 2017-09-210000-00-00NoNoCurrent
67046-807-286704608072828 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-28) 2017-09-210000-00-00NoNoCurrent
67046-807-306704608073030 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-30) 2017-09-210000-00-00NoNoCurrent
67046-807-606704608076060 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (67046-807-60) 2017-09-210000-00-00NoNoCurrent