Valproic acid

Product NDC
50383-792
Requested package NDC
50383-792-16
11-digit product format
503830792
Labeler code
50383
Product ID
50383-792_365491ba-2d9d-48b4-9014-ace7ad402433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
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
No
Listing certified through
2023-12-31
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 packagepackage50383-79250383-792-16IInactivated by FDA2026-08-11

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 · 15 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074060-001VALPROIC ACID250MG/5MLSYRUP / ORALAA1995-01-13cb3db0bc1861…

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
50383-792-05Valproic acid5 mL in 1 CUP, UNIT-DOSESOLUTION530
50383-792-06Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-06Valproic acid4 in 1 CASESOLUTION430
50383-792-07Valproic acid10 in 1 CASESOLUTION1030
50383-792-07Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-10Valproic acid10 mL in 1 CUP, UNIT-DOSESOLUTION1030
50383-792-12Valproic acid10 in 1 TRAYSOLUTION1030
50383-792-12Valproic acid10 in 1 CASESOLUTION1030
50383-792-16Valproic acid473 mL in 1 BOTTLESOLUTION47330

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-792-05ML - Milliliter50383-7927e8554a9-6945-4fbc-8b08-abf9e98330d312014-02-04
50383-792-06ML - Milliliter50383-792104d12b5-2954-4e94-b3ab-dd9529ed38f212014-02-04
50383-792-07ML - Milliliter50383-792a2a62f03-5f98-483a-a1fb-39bc0ea8200112014-02-04
50383-792-10ML - Milliliter50383-7921fec1bef-492c-4af2-a6b5-0c0cb90dace712014-02-04
50383-792-12ML - Milliliter50383-792169ec525-6cdd-47a8-bed3-6f5206ad76e112014-02-04
50383-792-16ML - Milliliter50383-7923c1e03f9-5884-400f-bb34-9886df611bad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
RASPBERRYINACTIVE INGREDIENT4N14V5R27WVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [HI-TECH PHARMACAL CO., INC.]16
VALPROIC ACIDACTIVE INGREDIENT614OI1Z5WIVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
RASPBERRYINACTIVE INGREDIENT4N14V5R27WVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554VALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RVALPROIC ACID SOLUTION [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-792VALPROIC ACID SOLUTION [AKORN]30Legacy NDC, 9 package rows20220916_84bbc23d-9bd3-4d48-9b64-d6eef64214b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN84bbc23d-9bd3-4d48-9b64-d6eef64214b430
1099687valproic acid 50 MG/ML Oral SolutionSCD84bbc23d-9bd3-4d48-9b64-d6eef64214b430
1099687valproate sodium 50 MG/ML SyrupSY84bbc23d-9bd3-4d48-9b64-d6eef64214b430
1099687valproic acid 250 MG per 5 ML Oral SolutionSY84bbc23d-9bd3-4d48-9b64-d6eef64214b430
1099687valproic acid 500 MG per 10 ML Oral SolutionSY84bbc23d-9bd3-4d48-9b64-d6eef64214b430
1099687VPA 50 MG/ML Oral SolutionSY84bbc23d-9bd3-4d48-9b64-d6eef64214b430
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-792-1650383079216473 mL in 1 BOTTLE (50383-792-16) 473 ml1995-01-130000-00-00NoNoCurrent