Levetiracetam

Product NDC
60687-657
11-digit product format
606870657
Labeler code
60687
Product ID
60687-657_1b6c29f4-60eb-4ba5-e063-6394a90a3063
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078993
Marketing category
ANDA
Marketing start
2022-08-04
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-657-01Levetiracetam100 in 1 CARTONTABLET, FILM COATED1002
60687-657-11Levetiracetam1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-657-01EA - Each60687-6572bbdb92f-cdea-4d27-b5a2-e7cbfa65928312022-05-04
60687-657-11EA - Each60687-657fac61281-d86a-4c2f-8383-c0a5e1e3b7f212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-657LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2Current NDC, Legacy NDC, 2 package rows20240625_031a32e1-675a-4efe-a66b-40beb4fe5101.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN031a32e1-675a-4efe-a66b-40beb4fe51012
311289levETIRAcetam 500 MG Oral TabletPSN031a32e1-675a-4efe-a66b-40beb4fe51012
387003levetiracetam 1000 MG Oral TabletSCD031a32e1-675a-4efe-a66b-40beb4fe51012
311289levetiracetam 500 MG Oral TabletSCD031a32e1-675a-4efe-a66b-40beb4fe51012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-657-0160687065701100 BLISTER PACK in 1 CARTON (60687-657-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-657-11) 100 blister pack2022-08-040000-00-00NoNoCurrent
60687-657-11606870657111 in 1 BLISTER PACKHistorical