Divalproex Sodium

Product NDC
62756-797
11-digit product format
627560797
Labeler code
62756
Product ID
62756-797_9fa8a32e-7def-4ae6-b537-15450ef34bc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
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
2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078597-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29
A078597-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29
A078597-003DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078597-001AB
A078597-002AB
A078597-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078597-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078597-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078597-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078597-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078597-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078597-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078597-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078597-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078597-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078597-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078597-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078597-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078597-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078597-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078597-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078597-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078597-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078597-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078597-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078597-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078597-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078597-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078597-001AB11e350fbaab3a…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099625Internal RxNorm lookup
1099678Internal RxNorm lookup
1099870Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
64797788-fdcb-4d12-a1a4-743ad71bd17bAvailable 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-797-08Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034
62756-797-13Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50034
62756-797-18Divalproex Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100034
62756-797-83Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3034
62756-797-88Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-797-13EA - Each62756-7971146462c-8eeb-4f67-a959-721c8809d4b112012-07-24
62756-797-88EA - Each62756-797b90f7704-942b-41ff-9fdc-3e69dc08a03c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
POVIDONEINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]9
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-797DIVALPROEX SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]31Current NDC, Legacy NDC, 5 package rows20250226_64797788-fdcb-4d12-a1a4-743ad71bd17b.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.bb94bbb1-07c1-49be-8c2c-f5635c65366d2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.90225548-85a8-4ea7-95d3-e8231c36fe5a2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.a67855ff-a879-43f0-bca3-94c304348bf52026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a95333-9fc1-7a9f-e063-6294a90a9f302026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions79132bea-04d8-4dd9-bd31-07f0ba805c212026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.cf15569c-5010-4e9b-aef0-7df4de5ed04e2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.ed24bb3a-bba1-4b27-8733-96619793fc152026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMSun Pharmaceutical Industries, Inc.64797788-fdcb-4d12-a1a4-743ad71bd17b2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
ndc (product): 62756-797
Divalproex SodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.d1d4d790-73d5-4a3b-a786-99f2c98125462026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC5e59609f-d79d-414b-a6fc-7efb1ba5b2002025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticalsfb39a94e-93e6-4afe-a300-f80e8f1e0fa62025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack47412563-ec3e-44fd-9f3f-c00b9b09033a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackcd6fe37a-d26d-4ae8-a894-b44878e6bf8e2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex Sodium D/RDIVALPROEX SODIUM D/RDirect_Rx3aff8f08-d8e8-cd13-e063-6394a90aa00c2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMCoupler LLC38f4f2fd-400b-ccc4-e063-6294a90a5f412025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMATLANTIC BIOLOGICALS CORP.57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc2025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack48a6e47a-3697-492d-9086-56e4ca0151e52025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMNuCare Pharmaceuticals,Inc.0bef10ed-e4b5-95ae-e063-6294a90a86eb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutionsc8f72850-92d5-4f64-b9f1-657f72bfa15a2024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078597
application number: ANDA078597

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNcd6fe37a-d26d-4ae8-a894-b44878e6bf8e103
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDcd6fe37a-d26d-4ae8-a894-b44878e6bf8e103
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN47412563-ec3e-44fd-9f3f-c00b9b09033a102
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD47412563-ec3e-44fd-9f3f-c00b9b09033a102
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD64797788-fdcb-4d12-a1a4-743ad71bd17b34
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN90225548-85a8-4ea7-95d3-e8231c36fe5a32
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD90225548-85a8-4ea7-95d3-e8231c36fe5a32
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNbb94bbb1-07c1-49be-8c2c-f5635c65366d9
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDbb94bbb1-07c1-49be-8c2c-f5635c65366d9
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDfb39a94e-93e6-4afe-a300-f80e8f1e0fa68
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc3
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0bef10ed-e4b5-95ae-e063-6294a90a86eb2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNd1d4d790-73d5-4a3b-a786-99f2c98125462
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNc8f72850-92d5-4f64-b9f1-657f72bfa15a2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0bef10ed-e4b5-95ae-e063-6294a90a86eb2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDd1d4d790-73d5-4a3b-a786-99f2c98125462
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDc8f72850-92d5-4f64-b9f1-657f72bfa15a2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN38f4f2fd-400b-ccc4-e063-6294a90a5f411
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN3aff8f08-d8e8-cd13-e063-6394a90aa00c1
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN51132e43-6fda-4cd4-a818-cfd399264e891
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN59b94f04-42a0-2100-e053-2991aa0ab8f11
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD38f4f2fd-400b-ccc4-e063-6294a90a5f411
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD3aff8f08-d8e8-cd13-e063-6394a90aa00c1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD51132e43-6fda-4cd4-a818-cfd399264e891
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD59b94f04-42a0-2100-e053-2991aa0ab8f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-797-0862756079708100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-08) 2008-07-290000-00-00NoNoCurrent
62756-797-1362756079713500 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-13) 2008-07-290000-00-00NoNoCurrent
62756-797-18627560797181000 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-18) 2008-07-290000-00-00NoNoCurrent
62756-797-836275607978330 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-83) 2008-07-290000-00-00NoNoCurrent
62756-797-8862756079788100 TABLET, DELAYED RELEASE in 1 BOTTLE (62756-797-88) 2008-07-290000-00-00NoNoCurrent