Home NDC 57664-124 VALPROIC ACID
Product NDC 57664-124
11-digit product format 576640124
Labeler code 57664
Product ID 57664-124_98b9c198-0ac9-4b96-9cce-d042640610bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form SOLUTION
Route ORAL
Labeler Caraco Pharmaceutical Laboratories, Ltd.
Application ANDA090517
Marketing category ANDA
Marketing start 2012-04-18
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 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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57664-124-34 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57664-124-34 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57664-124-34 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57664-124-34 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57664-124-34 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57664-124-34 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57664-124-34 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57664-124-34 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57664-124-34 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57664-124-34 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57664-124-34 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57664-124-34 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57664-124-34 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090517-001 VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090517-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090517-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 2010-05-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALPROIC ACID ACTIVE INGREDIENT 614OI1Z5WI VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R VALPROIC ACID SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.] 4
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VALPROIC ACID VALPROIC ACID QUAGEN PHARMACEUTICALS LLC 531c0fc7-5e80-49a5-a9d1-0916ec45d52c 2024-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090517 application number: ANDA090517