Home NDC 0591-4012 Valproic
Product NDC 0591-4012
11-digit product format 005914012
Labeler code 0591
Product ID 0591-4012_a64ec7af-329d-4b8c-ad44-eedb68ec8f40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valproic Acid
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA073229
Marketing category ANDA
Marketing start 2009-09-08
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
Listing expiration 2027-12-31 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 0591-4012-01 Valproic 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALPROIC ACID ACTIVE INGREDIENT 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 PEANUT OIL INACTIVE INGREDIENT 5TL50QU0W4 VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 7 VALPROIC ACID ACTIVE INGREDIENT 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 PEANUT OIL INACTIVE INGREDIENT 5TL50QU0W4 VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 5 VALPROIC ACID ACTIVE INGREDIENT 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 VALPROIC ACID ACTIVE INGREDIENT 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 VALPROIC ACID ACTIVE MOIETY 614OI1Z5WI VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1 PEANUT OIL INACTIVE INGREDIENT 5TL50QU0W4 VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 PEANUT OIL INACTIVE INGREDIENT 5TL50QU0W4 VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [CONTRACT PHARMACY SERVICES-PA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-4012 VALPROIC (VALPROIC ACID) CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 16 Current NDC, Legacy NDC, 1 package rows 20241030_cef3e335-5891-412f-89c4-79fcd2f145b7.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 ndc (product): 0591-4012 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
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 0591-4012-01 00591401201 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-4012-01) 2009-09-08 0000-00-00 No No Current