Divalproex sodium

Product NDC
71610-157
11-digit product format
716100157
Labeler code
71610
Product ID
71610-157_33511714-8ded-46ee-ae1d-03a536728d31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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 42.

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
A202419-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02
A202419-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202419-001AB
A202419-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202419-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202419-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2014-06-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202419-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202419-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202419-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202419-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202419-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202419-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202419-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202419-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202419-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202419-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202419-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202419-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202419-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202419-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202419-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202419-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202419-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202419-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202419-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202419-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202419-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202419-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202419-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202419-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202419-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202419-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202419-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202419-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202419-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202419-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202419-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202419-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202419-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202419-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202419-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202419-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202419-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202419-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202419-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202419-002AB1bb7c543d1eb4…

Additional Listing Data#

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

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
ad5e8bd8-c923-40f0-a106-55620c4247d7Available 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
71610-157-60Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71610-157-75Divalproex sodium150 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-157-60EA - Each71610-15794c2818c-5f0c-4535-bbc9-60fe9ff6990e12020-06-05
71610-157-75EA - Each71610-1574ab8ad66-e76b-4a13-8859-372991ebbcd612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-157DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20181017_ad5e8bd8-c923-40f0-a106-55620c4247d7.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex sodiumDIVALPROEX SODIUMAurobindo Pharma Limited6240cee7-6aa8-425c-ba46-f889a640f0fa2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLCaab6b411-11e9-4a16-afb6-d471ba4756e92026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC41e32cd5-1393-4ef1-81cb-8e3795e306822026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMREMEDYREPACK INC.7e96b724-5f5f-43cb-8d8b-adff3e1fc7792026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions3df910c5-b6f0-4a65-9640-b702ecea49f92026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMA-S Medication Solutions94eac383-a89f-4128-b81c-076640b8edcf2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0669ac77-10df-48af-bc42-55e768b69e4f2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepacke4a815eb-ea20-482a-bb67-06ab342645152025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf2025-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC9a9f5f24-e421-406f-ac91-d1f964245f542024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC177e34e9-f74d-42aa-8e3c-5fb4f41c23222018-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCad5e8bd8-c923-40f0-a106-55620c4247d72018-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202419
application number: ANDA202419
ndc (product): 71610-157

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNad5e8bd8-c923-40f0-a106-55620c4247d71
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDad5e8bd8-c923-40f0-a106-55620c4247d71
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYad5e8bd8-c923-40f0-a106-55620c4247d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-157-607161001576090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-157-60) 2018-09-200000-00-00NoNoCurrent
71610-157-7571610015775150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-157-75) 2018-09-200000-00-00NoNoCurrent