Divalproex Sodium

Product NDC
51079-767
11-digit product format
510790767
Labeler code
51079
Product ID
51079-767_4358cbe3-b1da-4ab0-e063-6394a90afa64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-02-03
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077567-001DIVALPROEX 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…
2021-12-28 21:50 UTC2021-12A077567-001DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077567-002DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, EXTENDED RELEASE / ORALAB2009-01-29782e0a99824c…

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
2026-02-19 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…
2021-12-28 21:50 UTC2021-12A077567-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077567-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099563Internal RxNorm lookup
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
b367d81d-4eca-4e28-b490-34be4c003561Available 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
51079-767-01Divalproex Sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE122
51079-767-08Divalproex Sodium80 in 1 CARTONTABLET, FILM COATED, EXTENDED RE8022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-767-01EA - Each51079-767a82409c6-1fcf-4a77-b7c2-101cb8a3bfd512012-07-24
51079-767-08EA - Each51079-767104f9078-bd52-49db-8cf5-736aea852ce912012-07-24
51079-767-30EA - Each51079-767cd76d313-4f53-4e16-ba88-939da1e904e912012-07-24
51079-767-56EA - Each51079-767c17566ac-9c38-4937-bf8f-73c4c4175d1f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]6
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-767DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]20Current NDC, Legacy NDC, 2 package rows20231228_b367d81d-4eca-4e28-b490-34be4c003561.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
ndc (product): 51079-767
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
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 TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNb367d81d-4eca-4e28-b490-34be4c00356122
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDb367d81d-4eca-4e28-b490-34be4c00356122
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYb367d81d-4eca-4e28-b490-34be4c00356122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-767-01510790767011 in 1 BLISTER PACKHistorical
51079-767-085107907670880 BLISTER PACK in 1 CARTON (51079-767-08) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-767-01) 80 blister pack2009-02-030000-00-00NoNoCurrent