Divalproex Sodium

Product NDC
55154-4759
11-digit product format
551544759
Labeler code
55154
Product ID
55154-4759_d6b874c5-c383-4b28-8be1-2098e4d4fd0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078919
Marketing category
ANDA
Marketing start
2009-03-18
Substance
DIVALPROEX SODIUM
Active strength
125 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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078919-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078919-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-273f01610625f2…
2019-09-15 20:21 UTC2019-09A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078919-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078919-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078919-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078919-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078919-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078919-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078919-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078919-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078919-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078919-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078919-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078919-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078919-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078919-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078919-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078919-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078919-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078919-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078919-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078919-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078919-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078919-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078919-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078919-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078919-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078919-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078919-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078919-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078919-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078919-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078919-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078919-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078919-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078919-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078919-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078919-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078919-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078919-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078919-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078919-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078919-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
644VL95AO6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099596Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e86a610-45ef-4be7-a3ab-f656f5b32706Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4759-0Divalproex Sodium10 in 1 BAGCAPSULE, COATED PELLETS1015
55154-4759-0Divalproex Sodium1 in 1 BLISTER PACKCAPSULE, COATED PELLETS115

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4759DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 2 package rows20250524_8e86a610-45ef-4be7-a3ab-f656f5b32706.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC8e86a610-45ef-4be7-a3ab-f656f5b327062026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078919
application number: ANDA078919
ndc (product): 55154-4759
divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.ab8616a5-ea72-4df7-b095-54ea19ef6fba2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078919
application number: ANDA078919
divalproex sodiumDIVALPROEX SODIUMZydus Pharmaceuticals USA Inc.ed710c62-8ba6-4f19-b240-3ee73cd03d672026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078919
application number: ANDA078919
divalproex sodiumDIVALPROEX SODIUMATLANTIC BIOLOGICALS CORP.699a9722-27bd-4e90-819b-d4ecb99466c82025-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078919
application number: ANDA078919
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaging2e4778d8-8798-4da1-bb33-1aa1414b58092025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078919
application number: ANDA078919
divalproex sodiumDIVALPROEX SODIUMZydus Lifesciences Limitedb0f33792-dd96-40cc-a28e-acdcdca2f4b82024-11-28Exact identifier
application applno (ANDA): 078919
application number: ANDA078919

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN8e86a610-45ef-4be7-a3ab-f656f5b3270615
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD8e86a610-45ef-4be7-a3ab-f656f5b3270615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4759-05515447590010 BLISTER PACK in 1 BAG (55154-4759-0) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK10 blister pack2009-03-180000-00-00NoNoCurrent