Valproic

Product NDC
67046-805
11-digit product format
670460805
Labeler code
67046
Product ID
67046-805_6541ab19-3cfc-4786-9cfe-0455f428edb5
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
2010-04-05
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-805IInactivated by FDA2026-08-17
excluded packagepackage67046-80567046-805-30IInactivated 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-805-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-805-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-805-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-805-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-805-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-805-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-805-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-805-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-805-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-805-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-805-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-805-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-805-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-805-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-805-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-805-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-805-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-805-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67046-805-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67046-805-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67046-805-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67046-805-30110d247fa046…a55b01930146…

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-805-302019-10-21C16284748780-1956f9ecf-bdf0-621f-e053-dbdaa90a74adValproic Acid Liquid Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-805-30Valproic30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-805VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100406_6541ab19-3cfc-4786-9cfe-0455f428edb5.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 CapsulePSN6541ab19-3cfc-4786-9cfe-0455f428edb51
1099681valproic acid 250 MG Oral CapsuleSCD6541ab19-3cfc-4786-9cfe-0455f428edb51
1099681VPA 250 MG Oral CapsuleSY6541ab19-3cfc-4786-9cfe-0455f428edb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-805-306704608053030 in 1 BLISTER PACKHistorical