Levetiracetam

Product NDC
50268-470
11-digit product format
502680470
Labeler code
50268
Product ID
50268-470_d5ddc7ca-fcb2-c72c-e053-2a95a90a54e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
AvPAK
Application
ANDA203052
Marketing category
ANDA
Marketing start
2019-10-14
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-470-132025-03-11C16284748780-12cef2736-8872-d83d-e063-dadaa90ab31f94e68b30-80e1-2516-e053-2995a90aca27
50268-470-132025-01-30C16284748780-12cef2736-8872-d83d-e063-dadaa90ab31f94e68b30-80e1-2516-e053-2995a90aca27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-470-11ML - Milliliter50268-4709b8d8964-dae1-4f87-8526-60b2377f69f112019-11-12
50268-470-13ML - Milliliter50268-4708d0bbe54-44e0-4fdd-8abb-1e213871486812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-470LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [AVPAK]4Legacy NDC20250313_94e68b30-80e1-2516-e053-2995a90aca27.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-470-135026804701330 BLISTER PACK in 1 BOX (50268-470-13) > 5 mL in 1 BLISTER PACK (50268-470-11) 30 blister pack2019-10-140000-00-00NoNoCurrent