Valproic Acid

Product NDC
67046-807
Requested package NDC
67046-807-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-80767046-807-07IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073484-001VALPROIC ACIDVALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A073484-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09A073484-001VALPROIC ACID250MGCAPSULE / ORALAB1993-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A073484-001VALPROIC ACID250MGCAPSULE / ORALAB1993-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073484-001VALPROIC ACID250MGCAPSULE / ORALABRS1993-06-29e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A073484-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073484-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073484-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073484-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073484-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073484-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073484-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073484-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073484-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073484-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073484-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073484-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073484-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073484-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073484-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073484-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073484-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073484-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073484-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073484-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073484-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073484-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073484-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073484-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073484-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073484-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073484-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073484-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073484-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073484-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073484-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073484-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073484-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073484-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073484-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073484-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073484-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073484-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073484-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073484-001AB1e64feba35796…

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, Related label table
NDCRelated label
67046-807-07807 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
67046-807-14807 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
67046-807-15807 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
67046-807-20807 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
67046-807-21807 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
67046-807-28807 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
67046-807-30807 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
67046-807-60807 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valproic AcidVALPROIC ACIDBionpharma Inc.ceb52870-76d0-4108-a1d4-ba7096fbacdd2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484
Valproic AcidVALPROIC ACIDREMEDYREPACK INC.ec41025a-ed7d-48c8-9005-08e3a9417f302026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484
Valproic AcidVALPROIC ACIDATLANTIC BIOLOGICALS CORP.453444b6-1f50-49de-ab3c-1e429c83bffa2025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484
Valproic AcidVALPROIC ACIDNCS HealthCare of KY, LLC dba Vangard Labs8785a152-3010-4370-aaf5-11315a1a56e12025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484
Valproic AcidVALPROIC ACIDBryant Ranch Prepacka9cef1ec-ba52-4849-8889-87898d6f41992025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484
Valproic AcidVALPROIC ACIDAphena Pharma Solutions - Tennessee, LLC3798f957-8b32-4ac0-8fd1-80283414c2552017-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073484
application number: ANDA073484

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