FDA.reportPublic FDA data

Divalproex sodium

Product NDC
68180-261
11-digit product format
681800261
Labeler code
68180
Product ID
68180-261_9f0c730e-9756-4a9a-9277-b4ef5ca07604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA209286
Marketing category
ANDA
Marketing start
2020-09-18
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

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 Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-261-01Divalproex sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE10020
68180-261-02Divalproex sodium500 in 1 BOTTLETABLET, EXTENDED RELEASE50020
68180-261-06Divalproex sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-261DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 3 package rows20240508_1f081c74-9f73-4ed9-9157-8d73d586a409.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN0822300b-68c0-4e70-b1ba-8eb42cf373f7105
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD0822300b-68c0-4e70-b1ba-8eb42cf373f7105
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY0822300b-68c0-4e70-b1ba-8eb42cf373f7105
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN1f081c74-9f73-4ed9-9157-8d73d586a40920
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN1f081c74-9f73-4ed9-9157-8d73d586a40920
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD1f081c74-9f73-4ed9-9157-8d73d586a40920
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD1f081c74-9f73-4ed9-9157-8d73d586a40920
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY1f081c74-9f73-4ed9-9157-8d73d586a40920
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY1f081c74-9f73-4ed9-9157-8d73d586a40920
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN83a77f60-ed58-4fa0-a584-e6a0c767d19d4
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD83a77f60-ed58-4fa0-a584-e6a0c767d19d4
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY83a77f60-ed58-4fa0-a584-e6a0c767d19d4
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNf86f185b-4acb-43b5-e053-6394a90a681c2
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDf86f185b-4acb-43b5-e053-6394a90a681c2
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYf86f185b-4acb-43b5-e053-6394a90a681c2
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN51c1d8be-2013-42d7-909c-b00d32cf29f31
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN8697a048-a4d4-4934-a382-b73dba7f0cff1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD51c1d8be-2013-42d7-909c-b00d32cf29f31
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD8697a048-a4d4-4934-a382-b73dba7f0cff1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY51c1d8be-2013-42d7-909c-b00d32cf29f31
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY8697a048-a4d4-4934-a382-b73dba7f0cff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-261-0168180026101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-261-01) 2020-09-180000-00-00NoNoCurrent
68180-261-0268180026102500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-261-02) 2020-09-180000-00-00NoNoCurrent
68180-261-066818002610630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-261-06) 2020-09-180000-00-00NoNoCurrent