Divalproex Sodium

Product NDC
71610-030
11-digit product format
716100030
Labeler code
71610
Product ID
71610-030_fd96336e-88f7-4dbe-95c3-6af522e39ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-01-29
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
A077567-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29
A077567-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077567-001AB
A077567-002AB

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 06:07:402026-07A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29bb7c543d1eb4…

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 06:07:402026-07A077567-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077567-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077567-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077567-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077567-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077567-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077567-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077567-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077567-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077567-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077567-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077567-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077567-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077567-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077567-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077567-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077567-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077567-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077567-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077567-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077567-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077567-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077567-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077567-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077567-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077567-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077567-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077567-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077567-002AB1bb7c543d1eb4…

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
bf34dd25-abe3-4587-b481-df052f085429Available 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
71610-030-30Divalproex Sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE303
71610-030-60Divalproex Sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE903
71610-030-75Divalproex Sodium150 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1503
71610-030-80Divalproex Sodium180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1803
71610-030-92Divalproex Sodium270 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-030-30EA - Each71610-0302abbb182-ce2c-4c2e-8b73-2fa8aef7446012024-06-10
71610-030-60EA - Each71610-0303f699813-d88f-4b9c-afc1-21e9ee3bbdad12018-04-19
71610-030-75EA - Each71610-03017b69eec-f139-4bca-b3f7-9c71c435a33c12018-04-19
71610-030-80EA - Each71610-03058bac01f-e908-47e4-a8cb-5d6b0535bd6012024-04-05
71610-030-92EA - Each71610-0305df67ada-014a-48b1-ae1e-8a34bf284b3212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-030DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20230804_bf34dd25-abe3-4587-b481-df052f085429.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMMylan Pharmaceuticals Inc.00332c65-edad-a153-9c78-628931daa7322026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMSafecor Health, LLC3aec1944-86a1-490c-a734-d9dd3b52c9d62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMMylan Institutional Inc.b367d81d-4eca-4e28-b490-34be4c0035612025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCbf34dd25-abe3-4587-b481-df052f0854292023-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567
ndc (product): 71610-030
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC0f5bb45e-836b-48ce-9764-2d50edcb202c2023-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077567
application number: ANDA077567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNbf34dd25-abe3-4587-b481-df052f0854293
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDbf34dd25-abe3-4587-b481-df052f0854293
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYbf34dd25-abe3-4587-b481-df052f0854293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-030-307161000303030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-30) 2018-11-12NoNoCurrent
71610-030-607161000306090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-60) 2018-01-180000-00-00NoNoCurrent
71610-030-7571610003075150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-75) 2018-02-090000-00-00NoNoCurrent
71610-030-8071610003080180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-80) 2019-07-10NoNoCurrent
71610-030-9271610003092270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-92) 2019-07-10NoNoCurrent