FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
81665-101
11-digit product format
816650101
Labeler code
81665
Product ID
81665-101_c50830af-76fa-476a-a88d-50f38f9ecc42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Omnivium Pharmaceuticals LLC
Application
ANDA212688
Marketing category
ANDA
Marketing start
2023-05-05
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEVETIRACETAM
Brand name suffix
Extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui807832, 846378

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81665-101-12LEVETIRACETAMExtended-release120 in 1 BOTTLETABLET, EXTENDED RELEASE12011
81665-101-60LEVETIRACETAMExtended-release60 in 1 BOTTLETABLET, EXTENDED RELEASE6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81665-101LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [OMNIVIUM PHARMACEUTICALS LLC]10Current NDC, 2 package rows20240528_1a31134d-6b63-4d14-8445-0ed132e6c88d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN1a31134d-6b63-4d14-8445-0ed132e6c88d11
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN1a31134d-6b63-4d14-8445-0ed132e6c88d11
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD1a31134d-6b63-4d14-8445-0ed132e6c88d11
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD1a31134d-6b63-4d14-8445-0ed132e6c88d11
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY1a31134d-6b63-4d14-8445-0ed132e6c88d11
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY1a31134d-6b63-4d14-8445-0ed132e6c88d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81665-101-1281665010112120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-12) 2023-05-05NoNoCurrent
81665-101-608166501016060 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-101-60) 2023-05-05NoNoCurrent