Divalproex Sodium

Product NDC
68180-267
11-digit product format
681800267
Labeler code
68180
Product ID
68180-267_0a9f300c-ee8c-43c4-bccf-78cd862a7ac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078790
Marketing category
ANDA
Marketing start
2008-07-29
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68180-26768180-267-01DDiscontinued by firm2026-10-05
excluded packagepackage68180-26768180-267-02DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0568180-267-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0568180-267-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2668180-267-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2668180-267-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3168180-267-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3168180-267-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2868180-267-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2868180-267-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2168180-267-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2168180-267-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1068180-267-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1068180-267-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3168180-267-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3168180-267-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2068180-267-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2068180-267-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1068180-267-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1068180-267-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0868180-267-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0868180-267-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0368180-267-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0368180-267-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0968180-267-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0968180-267-01557ba5c1ecfa…9c80585c8c6e…

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

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
A078790-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29
A078790-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29
A078790-003DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-2984e616aacf4f…
2026-09-14 22:38:342026-08A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-2984e616aacf4f…
2026-08-18 06:07:402026-07A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORAL2008-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078790-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2008-07-29301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078790-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078790-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078790-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078790-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078790-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078790-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078790-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078790-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078790-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078790-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078790-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078790-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078790-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078790-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078790-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078790-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078790-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078790-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078790-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078790-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078790-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078790-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078790-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078790-001AB18072bd15b7f6…

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
Listing expiration
2027-12-31

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 · 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
33798a7c-c5a9-49a5-be5d-1312910ef468Available 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
68180-267-01Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10028
68180-267-02Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50028
68180-267-03Divalproex Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100028
68180-267-11Divalproex Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-267-01EA - Each68180-2672b05cee5-6b34-4bcf-a80e-d0e76e9c934212012-07-24
68180-267-02EA - Each68180-26744f9f9ae-4141-4df1-b77a-0f0821d39b8812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-267DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 4 package rows20250321_33798a7c-c5a9-49a5-be5d-1312910ef468.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMLupin Pharmaceuticals, Inc.33798a7c-c5a9-49a5-be5d-1312910ef4682026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078790
application number: ANDA078790
ndc (product): 68180-267

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNf738ddad-fef0-43cb-b791-b046fdcec3111
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNf738ddad-fef0-43cb-b791-b046fdcec3111
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDf738ddad-fef0-43cb-b791-b046fdcec3111
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD9b3db659-f64c-4c48-946a-6b4f1d800eba1
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDf738ddad-fef0-43cb-b791-b046fdcec3111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-267-0168180026701100 TABLET, DELAYED RELEASE in 1 BOTTLE (68180-267-01) 2008-07-290000-00-00NoNoCurrent
68180-267-0268180026702500 TABLET, DELAYED RELEASE in 1 BOTTLE (68180-267-02) 2008-07-290000-00-00NoNoCurrent
68180-267-03681800267031000 TABLET, DELAYED RELEASE in 1 BOTTLE (68180-267-03) 2008-07-290000-00-00NoNoCurrent
68180-267-116818002671110 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68180-267-11) 2008-07-290000-00-00NoNoCurrent