Home NDC 72189-010 Valproic Acid
Product NDC 72189-010
11-digit product format 721890010
Labeler code 72189
Product ID 72189-010_2c290b36-b0f4-2265-e063-6394a90af311
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form CAPSULE
Route ORAL
Labeler Direct_Rx
Application ANDA073229
Marketing category ANDA
Marketing start 2019-06-21
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 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 Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72189-010-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72189-010-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72189-010-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72189-010-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72189-010-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-010-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-010-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 72189-010-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 72189-010-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 72189-010-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 72189-010-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 72189-010-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 72189-010-30 1332a3947898…d4bfe170f9cd…
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 A073229-001 VALPROIC ACID VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073229-001 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 · 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 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073229-001 VALPROIC ACID 250MG CAPSULE / ORAL AB 1991-10-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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/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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-010-30 Valproic Acid 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-010 VALPROIC ACID CAPSULE VALPROIC ACID CAPSULE [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20210918_8bdbacb1-b38a-3282-e053-2a95a90af022.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 VALPROIC ACID Actavis Pharma, Inc. cef3e335-5891-412f-89c4-79fcd2f145b7 2026-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073229 application number: ANDA073229 valproic acid VALPROIC ACID Upsher-Smith Laboratories, LLC 7d4df6ad-3d53-4664-9200-749487bf3689 2025-07-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073229 application number: ANDA073229 Valproic VALPROIC ACID Aphena Pharma Solutions - Tennessee, LLC 34a0d45a-4388-7d8b-e063-6394a90a6c3f 2025-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073229 application number: ANDA073229 Valproic Acid VALPROIC ACID Direct_Rx 8bdbacb1-b38a-3282-e053-2a95a90af022 2025-01-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073229 application number: ANDA073229 ndc (product): 72189-010 valproic acid VALPROIC ACID Aphena Pharma Solutions - Tennessee, LLC 3904177b-8a26-4356-9080-d2a2e3f468af 2017-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073229 application number: ANDA073229
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72189-010-30 72189001030 30 CAPSULE in 1 BOTTLE (72189-010-30) 30 capsule 2019-06-21 0000-00-00 No No Current