Levetiracetam

Product NDC
50090-5760
11-digit product format
500905760
Labeler code
50090
Product ID
50090-5760_7d249b46-7411-49fd-9212-bb66be2b6654
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5760-0Levetiracetam1 in 1 BLISTER PACKTABLET, FILM COATED11
50090-5760-0Levetiracetam32 in 1 CARTONTABLET, FILM COATED321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5760LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20211007_38e5c7fd-6a71-4671-bf65-bda0929a372e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN38e5c7fd-6a71-4671-bf65-bda0929a372e1
311289levetiracetam 500 MG Oral TabletSCD38e5c7fd-6a71-4671-bf65-bda0929a372e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5760-05009057600032 BLISTER PACK in 1 CARTON (50090-5760-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK32 blister pack2021-10-010000-00-00NoNoCurrent