Home NDC 43353-085 valproic acid
Product NDC 43353-085
11-digit product format 433530085
Labeler code 43353
Product ID 43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valproic acid
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA073229
Marketing category ANDA
Marketing start 2011-10-29
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-085-53 valproic acid 60 in 1 BOTTLE CAPSULE 60 3 43353-085-60 valproic acid 90 in 1 BOTTLE CAPSULE 90 3 43353-085-70 valproic acid 120 in 1 BOTTLE CAPSULE 120 3 43353-085-80 valproic acid 180 in 1 BOTTLE CAPSULE 180 3 43353-085-90 valproic acid 240 in 1 BOTTLE CAPSULE 240 3 43353-085-94 valproic acid 360 in 1 BOTTLE CAPSULE 360 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-085 VALPROIC ACID CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Current NDC, Legacy NDC, 6 package rows 20171018_3904177b-8a26-4356-9080-d2a2e3f468af.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 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 ndc (product): 43353-085
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 43353-085-53 43353008553 60 CAPSULE in 1 BOTTLE (43353-085-53) 60 capsule 2015-07-20 0000-00-00 No No Current 43353-085-60 43353008560 90 CAPSULE in 1 BOTTLE (43353-085-60) 90 capsule 2015-07-20 0000-00-00 No No Current 43353-085-70 43353008570 120 CAPSULE in 1 BOTTLE (43353-085-70) 120 capsule 2015-12-16 0000-00-00 No No Current 43353-085-80 43353008580 180 CAPSULE in 1 BOTTLE (43353-085-80) 180 capsule 2015-12-15 0000-00-00 No No Current 43353-085-90 43353008590 240 CAPSULE in 1 BOTTLE (43353-085-90) 240 capsule 2016-05-23 0000-00-00 No No Current 43353-085-94 43353008594 360 CAPSULE in 1 BOTTLE (43353-085-94) 360 capsule 2015-10-28 0000-00-00 No No Current