Divalproex sodium

Product NDC
55111-532
11-digit product format
551110532
Labeler code
55111
Product ID
55111-532_a886188f-930f-fcf2-d361-a2a608f95154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Ltd
Application
ANDA078979
Marketing category
ANDA
Marketing start
2009-01-23
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078979-001DIVALPROEX SODIUMDIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078979-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-233f01610625f2…
2019-09-15 20:21 UTC2019-09A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078979-001DIVALPROEX SODIUMEQ 125MG VALPROIC ACIDCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078979-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078979-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078979-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078979-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078979-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078979-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078979-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078979-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078979-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078979-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078979-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078979-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078979-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078979-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078979-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078979-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078979-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078979-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078979-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078979-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078979-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078979-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078979-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078979-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078979-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078979-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078979-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078979-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078979-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078979-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078979-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078979-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078979-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078979-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078979-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078979-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078979-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078979-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078979-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078979-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099596Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f911748c-fb3a-fe1a-ab2a-4b40455e05efAvailable 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
55111-532-01Divalproex sodium100 in 1 BOTTLECAPSULE, DELAYED RELEASE10031
55111-532-05Divalproex sodium500 in 1 BOTTLECAPSULE, DELAYED RELEASE50031
55111-532-30Divalproex sodium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3031
55111-532-78Divalproex sodium10 in 1 CARTONCAPSULE, DELAYED RELEASE1031
55111-532-79Divalproex sodium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-532-01EA - Each55111-532ce341af7-b47a-4e49-a66c-a9bb1423fa0412013-02-13
55111-532-05EA - Each55111-53286aa7f12-0dff-454d-8f99-138aafcc4f6d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
GELATININACTIVE INGREDIENT2G86QN327LDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
RAW SUGARINACTIVE INGREDIENT8M707QY5GHDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]25
divalproex sodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
valproic acidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
gelatinINACTIVE INGREDIENT2G86QN327LDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
hypromellosesINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
magnesium stearateINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
raw sugarINACTIVE INGREDIENT8M707QY5GHDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM CAPSULE [DR. REDDY'S LABORATORIES LTD]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-532DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD]29Current NDC, Legacy NDC, 5 package rows20250504_f911748c-fb3a-fe1a-ab2a-4b40455e05ef.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 SODIUMMajor Pharmaceuticals4a0fa934-ec8c-460e-86eb-11281728fe852026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078979
application number: ANDA078979
Divalproex sodiumDIVALPROEX SODIUMCardinal Health 107, LLC0816a066-9ee3-4c23-944d-3539fc2c12bf2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078979
application number: ANDA078979
Divalproex sodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltdf911748c-fb3a-fe1a-ab2a-4b40455e05ef2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078979
application number: ANDA078979
ndc (product): 55111-532
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLC589ae3a6-8b2e-d931-d36b-1937287ab5c02025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078979
application number: ANDA078979
Divalproex sodiumDIVALPROEX SODIUMNCS HealthCare of KY, LLC dba Vangard Labs388fd4bc-f12f-4e55-a1e7-72aa585519fa2024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078979
application number: ANDA078979

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNf911748c-fb3a-fe1a-ab2a-4b40455e05ef31
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDf911748c-fb3a-fe1a-ab2a-4b40455e05ef31
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN388fd4bc-f12f-4e55-a1e7-72aa585519fa28
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD388fd4bc-f12f-4e55-a1e7-72aa585519fa28
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN4a0fa934-ec8c-460e-86eb-11281728fe8512
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD4a0fa934-ec8c-460e-86eb-11281728fe8512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-532-0155111053201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-01) 2009-01-230000-00-00NoNoCurrent
55111-532-0555111053205500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-05) 2009-01-230000-00-00NoNoCurrent
55111-532-305511105323030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-30) 2009-01-230000-00-00NoNoCurrent
55111-532-785511105327810 BLISTER PACK in 1 CARTON (55111-532-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-532-79) 10 blister pack2009-01-230000-00-00NoNoCurrent
55111-532-795511105327910 in 1 BLISTER PACKHistorical