Home NDC 63629-2454 Valproic Acid
Product NDC 63629-2454
11-digit product format 636292454
Labeler code 63629
Product ID 63629-2454_fee430e4-2cf7-4384-a11a-3e5ea5bac5c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA073484
Marketing category ANDA
Marketing start 2016-07-15
Substance VALPROIC ACID
Active strength 250 mg/1
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 43 .
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 A073484-001 VALPROIC ACID VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073484-001 AB
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 · 43 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 2026-09-14 22:38:34 2026-08 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1993-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1993-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073484-001 VALPROIC ACID 250MG CAPSULE / ORAL AB RS 1993-06-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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/1
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 1099681 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 63629-2454-1 Valproic Acid 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2454 VALPROIC ACID CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 1 package rows 20250215_a9cef1ec-ba52-4849-8889-87898d6f4199.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valproic Acid VALPROIC ACID Bionpharma Inc. ceb52870-76d0-4108-a1d4-ba7096fbacdd 2026-05-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073484 application number: ANDA073484 Valproic Acid VALPROIC ACID ATLANTIC BIOLOGICALS CORP. 453444b6-1f50-49de-ab3c-1e429c83bffa 2025-06-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073484 application number: ANDA073484 Valproic Acid VALPROIC ACID NCS HealthCare of KY, LLC dba Vangard Labs 8785a152-3010-4370-aaf5-11315a1a56e1 2025-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073484 application number: ANDA073484 Valproic Acid VALPROIC ACID Bryant Ranch Prepack a9cef1ec-ba52-4849-8889-87898d6f4199 2025-01-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073484 application number: ANDA073484 ndc (product): 63629-2454 Valproic Acid VALPROIC ACID Aphena Pharma Solutions - Tennessee, LLC 3798f957-8b32-4ac0-8fd1-80283414c255 2017-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073484 application number: ANDA073484
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-2454-1 63629245401 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (63629-2454-1) 2025-01-24 0000-00-00 No No Current