Home NDC 81033-266 Valproic Acid
Product NDC 81033-266
11-digit product format 810330266
Labeler code 81033
Product ID 81033-266_3a214bf4-ea91-0892-e063-6394a90a9a9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma Corporation
Application ANDA073178
Marketing category ANDA
Marketing start 2024-01-02
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 42 .
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 A073178-001 VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073178-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1992-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073178-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1992-08-25 e64feba35796…
Observed Orange Book normalized TE history# 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 81033-266-05 Valproic Acid 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 81033-266-10 Valproic Acid 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 1 81033-266-50 Valproic Acid 100 in 1 CASE SOLUTION 100 1 81033-266-52 Valproic Acid 100 in 1 CASE SOLUTION 100 1
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valproic Acid VALPROIC ACID ANI Pharmaceuticals, Inc. 2314af65-b928-42a9-91eb-6372909ab4f5 2026-03-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073178 application number: ANDA073178 Valproic Acid VALPROIC ACID REMEDYREPACK INC. 1edd220d-d151-4177-9a29-9fee36489fb7 2025-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073178 application number: ANDA073178 Valproic Acid VALPROIC ACID Kesin Pharma Corporation 3a2155d0-e79d-3e11-e063-6294a90a4aae 2025-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073178 application number: ANDA073178 ndc (product): 81033-266 Valproic Acid VALPROIC ACID NorthStar Rx LLC 1286ab49-fa34-488e-e063-6394a90ad582 2024-05-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073178 application number: ANDA073178
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-266-05 81033026605 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 81033-266-10 81033026610 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 81033-266-50 81033026650 100 CUP, UNIT-DOSE in 1 CASE (81033-266-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-266-05) 2025-08-01 No No Current 81033-266-52 81033026652 100 CUP, UNIT-DOSE in 1 CASE (81033-266-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-266-10) 2025-08-01 No No Current