Levetiracetam

Product NDC
16571-788
11-digit product format
165710788
Labeler code
16571
Product ID
16571-788_12dcedc8-07a7-41c4-be05-2ccde6050fce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA078993
Marketing category
ANDA
Marketing start
2009-01-15
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-788-12EA - Each16571-788cbbd2a49-31f9-491e-95d7-eb15df35aac312021-11-09
16571-788-50EA - Each16571-7882439f6f7-5425-498f-9027-2638510d593312021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-788LEVETIRACETAM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]6Legacy NDC20240606_d2f5416c-631d-48cc-a6ce-f998c7217d70.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-788-1216571078812120 TABLET, FILM COATED in 1 BOTTLE (16571-788-12) 2009-01-150000-00-00NoNoCurrent
16571-788-5016571078850500 TABLET, FILM COATED in 1 BOTTLE (16571-788-50) 2009-01-150000-00-00NoNoCurrent