Valproic Acid

Product NDC
17856-0792
11-digit product format
178560792
Labeler code
17856
Product ID
17856-0792_ecfe5102-f404-416a-a0c1-a798f9446642
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA074060
Marketing category
ANDA
Marketing start
1995-01-13
Marketing end
0000-00-00
Substance
VALPROIC ACID
Active strength
250 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0792IInactivated by FDA2026-08-17
excluded packagepackage17856-079217856-0792-2DDiscontinued by firm2026-08-17
excluded packagepackage17856-079217856-0792-6DDiscontinued by firm2026-08-17

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0792-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0792-6DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0792-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0792-6DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0792-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0792-6DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0792-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0792-6DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0792-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0792-6DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0792-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0792-6DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0792-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0792-6DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0792-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0792-6DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0792-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0792-6DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0792-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0792-5IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0792-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0792-5IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0792-1IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0792-5IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0792-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0792-5IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0792-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0792-5IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-0792-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-0792-5IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage17856-0792-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage17856-0792-5EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A074060-001VALPROIC ACIDVALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13

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 06:07:402026-07A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074060-001VALPROIC ACID250MG/5MLSYRUP / ORAL1995-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074060-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074060-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074060-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074060-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074060-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074060-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074060-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A074060-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074060-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074060-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074060-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A074060-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074060-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074060-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074060-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074060-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074060-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074060-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074060-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074060-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074060-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074060-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074060-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074060-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074060-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074060-001AA1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0792-1Valproic Acid10 mL in 1 CUPSOLUTION106
17856-0792-2Valproic Acid72 in 1 BOX, UNIT-DOSESOLUTION726
17856-0792-5Valproic Acid5 mL in 1 CUPSOLUTION56
17856-0792-6Valproic Acid72 in 1 BOX, UNIT-DOSESOLUTION726

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0792VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORP.]6Legacy NDC, 4 package rows20240517_dce4388c-d663-4829-afa2-2329f0172245.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSNdce4388c-d663-4829-afa2-2329f01722456
1099687valproic acid 50 MG/ML Oral SolutionSCDdce4388c-d663-4829-afa2-2329f01722456
1099687valproate sodium 50 MG/ML SyrupSYdce4388c-d663-4829-afa2-2329f01722456
1099687valproic acid 250 MG per 5 ML Oral SolutionSYdce4388c-d663-4829-afa2-2329f01722456
1099687valproic acid 500 MG per 10 ML Oral SolutionSYdce4388c-d663-4829-afa2-2329f01722456
1099687VPA 50 MG/ML Oral SolutionSYdce4388c-d663-4829-afa2-2329f01722456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0792-11785607920110 mL in 1 CUP10 mlHistorical
17856-0792-21785607920272 in 1 BOX, UNIT-DOSEHistorical
17856-0792-5178560792055 mL in 1 CUP5 mlHistorical
17856-0792-61785607920672 in 1 BOX, UNIT-DOSEHistorical