Divalproex Sodium ER

Product NDC
72189-459
Requested package NDC
72189-459-60
11-digit product format
721890459
Labeler code
72189
Product ID
72189-459_2c4dbb36-4841-f211-e063-6294a90ad364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209286
Marketing category
ANDA
Marketing start
2023-04-03
Substance
DIVALPROEX SODIUM
Active strength
500 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-45972189-459-60UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-45972189-459-60UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209286-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18
A209286-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209286-001AB
A209286-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1884e616aacf4f…
2026-09-14 22:38:342026-08A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1884e616aacf4f…
2026-08-18 06:07:402026-07A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209286-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209286-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2019-10-1874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209286-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209286-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A209286-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209286-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209286-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209286-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209286-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209286-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209286-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209286-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209286-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209286-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209286-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209286-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209286-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209286-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209286-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209286-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209286-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209286-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209286-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209286-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209286-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209286-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209286-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209286-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209286-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 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
1099569Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f86f185b-4acb-43b5-e053-6394a90a681cAvailable 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
72189-459-60Divalproex Sodium ER60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-459-60EA - Each72189-459a30b1cc6-73e5-4766-92a0-11f7989f690c12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-459DIVALPROEX SODIUM ER TABLET, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 1 package rows20250123_f86f185b-4acb-43b5-e053-6394a90a681c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.aa386ae3-ceac-4e3b-8fb1-ced3107a4c542026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex sodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.392df14f-4d65-4be9-973b-1f0ce1013d8f2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.6af40b06-0a92-454c-9277-80e89de272312026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex sodiumDIVALPROEX SODIUMLupin Pharmaceuticals, Inc.1f081c74-9f73-4ed9-9157-8d73d586a4092026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex sodiumDIVALPROEX SODIUMPreferred Pharmaceuticals, Inc.83a77f60-ed58-4fa0-a584-e6a0c767d19d2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0822300b-68c0-4e70-b1ba-8eb42cf373f72025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
Divalproex Sodium ERDIVALPROEX SODIUM ERDirect_Rxf86f185b-4acb-43b5-e053-6394a90a681c2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286
ndc (package): 72189-459-60
ndc (product): 72189-459
ndc11 (package): 72189045960
Divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labs319bbead-bec8-4bb7-9ecb-b2e161c44b8d2024-09-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209286
application number: ANDA209286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNf86f185b-4acb-43b5-e053-6394a90a681c2
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDf86f185b-4acb-43b5-e053-6394a90a681c2
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYf86f185b-4acb-43b5-e053-6394a90a681c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-459-607218904596060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-459-60) 2023-04-03NoNoCurrent