Divalproex Sodium

Product NDC
0904-6363
11-digit product format
009046363
Labeler code
0904
Product ID
0904-6363_7b77fe8c-7100-4756-90ce-0dba2543d9e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090161
Marketing category
ANDA
Marketing start
2013-08-11
Substance
DIVALPROEX SODIUM
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 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
A090161-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090161-001AB

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 UTC2026-02A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090161-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2012-03-15cb3db0bc1861…

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 UTC2026-02A090161-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090161-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090161-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090161-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090161-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090161-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090161-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090161-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090161-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090161-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090161-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090161-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090161-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090161-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090161-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090161-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090161-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090161-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090161-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090161-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090161-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090161-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090161-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090161-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090161-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090161-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090161-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090161-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090161-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090161-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090161-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090161-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090161-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090161-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090161-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090161-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090161-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090161-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090161-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090161-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 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
1099563Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0Available 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
0904-6363-45Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE115
0904-6363-45Divalproex Sodium80 in 1 CARTONTABLET, EXTENDED RELEASE8015
0904-6363-61Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE115
0904-6363-61Divalproex Sodium100 in 1 CARTONTABLET, EXTENDED RELEASE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6363-45EA - Each0904-636374cddd8f-a795-4f52-8b92-78af515d22e112015-01-05
0904-6363-61EA - Each0904-636373ddf05e-9f43-4839-bcf4-37098942e36312017-11-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6363DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]13Current NDC, Legacy NDC, 4 package rows20250223_4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltd2e35f833-1cf7-12eb-9567-7a191e32e1382026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090161
application number: ANDA090161
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticals4ef6c5fd-42b2-4419-9b5a-e6d63571e3a02026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090161
application number: ANDA090161
ndc (product): 0904-6363
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.74a9f020-f7a1-44e2-a452-f0e37bd3e0772026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090161
application number: ANDA090161
Divalproex SodiumDIVALPROEX SODIUMCoupler LLC533245ba-7088-c929-e063-6294a90abe1d2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090161
application number: ANDA090161

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN4ef6c5fd-42b2-4419-9b5a-e6d63571e3a015
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD4ef6c5fd-42b2-4419-9b5a-e6d63571e3a015
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY4ef6c5fd-42b2-4419-9b5a-e6d63571e3a015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6363-450090463634580 BLISTER PACK in 1 CARTON (0904-6363-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK80 blister pack2013-08-110000-00-00NoNoCurrent
0904-6363-6100904636361100 BLISTER PACK in 1 CARTON (0904-6363-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2013-08-110000-00-00NoNoCurrent