Divalproex Sodium

Product NDC
60687-857
11-digit product format
606870857
Labeler code
60687
Product ID
60687-857_3a9c13b7-690a-9438-e063-6394a90ac202
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA079163
Marketing category
ANDA
Marketing start
2025-03-17
Substance
DIVALPROEX SODIUM
Active strength
125 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 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
A079163-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05
A079163-002DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05
A079163-003DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079163-001AB
A079163-002AB
A079163-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0584e616aacf4f…
2026-09-14 22:38:342026-08A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0584e616aacf4f…
2026-09-14 22:38:342026-08A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0584e616aacf4f…
2026-08-18 06:07:402026-07A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-002DIVALPROEX SODIUMEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-003DIVALPROEX SODIUMEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079163-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE / ORALAB2011-04-05301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079163-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079163-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A079163-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A079163-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079163-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079163-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079163-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079163-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079163-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079163-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079163-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079163-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079163-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079163-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079163-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079163-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079163-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079163-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079163-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079163-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079163-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079163-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079163-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079163-001AB1301d65b070ca…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 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
ca6bbec6-5631-4436-957e-fb8707e1683dAvailable 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
60687-857-11Divalproex Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12
60687-857-21Divalproex Sodium30 in 1 CARTONTABLET, DELAYED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-857-11EA - Each60687-8577d210e99-426a-4bc0-b4c9-423fe826d9d912025-03-04
60687-857-21EA - Each60687-857dbe5e6fc-ef9a-4878-a3ed-29518009bcff12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-857DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1Current NDC, 2 package rows20250112_ca6bbec6-5631-4436-957e-fb8707e1683d.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMUnit Dose Solutions, Inc.547d8305-bfc5-f4da-e063-6294a90a61062026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.beba3da1-e80d-45b4-9bd6-3ed85c9482f32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBluePoint Laboratoriesb95494e2-ee7a-7415-e053-2995a90ae8522026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMUnichem Pharmaceuticals (USA), Inc.1ec1a441-218a-4c80-a0cb-69bcc327f4722026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
DIVALPROEX SODIUMDIVALPROEX SODIUMDirectRxce12c7b1-caa9-4224-bb5f-3e20e0281d662026-03-17WarningsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMNorthwind Health Company, LLCab6fa448-7485-6644-e053-2a95a90aa1812026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack1107f190-bef1-41cb-9393-8479b0a560402025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack71296464-0c09-4ff2-beb3-377af77dc4cf2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack79e6dc26-a38b-4642-a216-1fa1213b919a2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackd67af03a-5261-4358-8787-2e729267ff7e2025-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packagingca6bbec6-5631-4436-957e-fb8707e1683d2025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
ndc (product): 60687-857
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackc8d9cd69-ceca-3057-9d1c-12c44b19f7672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack0fb57229-08ef-44d6-b40a-92b2f96ff7952025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions8ecfe765-d743-4308-9cd9-4a7b1a229ea92024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163
Divalproex SodiumDIVALPROEX SODIUMProficient Rx LPabac11e6-7ce1-491c-9ac3-61f3df54c4a42022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079163
application number: ANDA079163

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNca6bbec6-5631-4436-957e-fb8707e1683d2
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDca6bbec6-5631-4436-957e-fb8707e1683d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-857-11606870857111 in 1 BLISTER PACKHistorical
60687-857-216068708572130 BLISTER PACK in 1 CARTON (60687-857-21) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-857-11) 30 blister pack2025-03-17NoNoCurrent