Home NDC 70752-202 VALPROIC ACID
Product NDC 70752-202
11-digit product format 707520202
Labeler code 70752
Product ID 70752-202_a8e717fe-e79e-46f6-90da-8b8cfe78fae7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VALPROIC ACID
Dosage form SOLUTION
Route ORAL
Labeler QUAGEN PHARMACEUTICALS LLC
Application ANDA090517
Marketing category ANDA
Marketing start 2024-04-15
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 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base VALPROIC ACID
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALPROIC ACID 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 614OI1Z5WI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099687 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70752-202-12 VALPROIC ACID 473 mL in 1 BOTTLE SOLUTION 473 2 70752-202-12 VALPROIC ACID 12 in 1 CASE SOLUTION 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70752-202 VALPROIC ACID SOLUTION [QUAGEN PHARMACEUTICALS LLC] 2 Current NDC, 2 package rows 20240507_531c0fc7-5e80-49a5-a9d1-0916ec45d52c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70752-202-12 70752020212 12 BOTTLE in 1 CASE (70752-202-12) / 473 mL in 1 BOTTLE 12 bottle 2024-04-15 No No Current