Divalproex Sodium

Product NDC
71610-201
11-digit product format
716100201
Labeler code
71610
Product ID
71610-201_463f25a7-5120-4ca4-b572-502598615a09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIVALPROEX SODIUM
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078791
Marketing category
ANDA
Marketing start
2009-08-04
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-201-53EA - Each71610-201d3306153-92b4-4dcb-81d3-902fe4c0300d12019-02-13
71610-201-60EA - Each71610-201dd7bfc6a-6834-47a8-adcb-0018f2b29c2d12019-02-13
71610-201-70EA - Each71610-201e7ba2874-f9f3-42dc-8c25-364b234f274412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-201DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20190118_5d82d8bb-fb03-4922-937f-f53594bbcc05.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-201-537161002015360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-53) 2018-12-030000-00-00NoNoCurrent
71610-201-607161002016090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-60) 2018-12-030000-00-00NoNoCurrent
71610-201-7071610020170120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-70) 2018-12-030000-00-00NoNoCurrent