Home NDC 0116-4021 Valproic Acid
Product NDC 0116-4021
11-digit product format 001164021
Labeler code 0116
Product ID 0116-4021_4459a233-1fe1-41dc-e063-6394a90a5ab4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form SOLUTION
Route ORAL
Labeler Xttrium Laboratories Inc.
Application ANDA070868
Marketing category ANDA
Marketing start 1986-07-01
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 2027-12-31
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 A070868-001 VALPROIC ACID VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01
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 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL AA 1986-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070868-001 VALPROIC ACID 250MG/5ML SYRUP / ORAL 1986-07-01 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Valproic Acid
Listing expiration 2027-12-31 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# 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 0116-4021-05 00116402105 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0116-4021-10 00116402110 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0116-4021-11 00116402111 10 TRAY in 1 CASE (0116-4021-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4021-10) 10 tray 2025-07-29 No No Current 0116-4021-16 00116402116 473 mL in 1 BOTTLE, PLASTIC (0116-4021-16) 473 ml 2025-07-29 No No Current 0116-4021-40 00116402140 4 TRAY in 1 CASE (0116-4021-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05) 4 tray 2025-07-29 No No Current 0116-4021-41 00116402141 10 TRAY in 1 CASE (0116-4021-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05) 10 tray 2025-07-29 No No Current