FDA.reportPublic FDA data

Levetiracetam

Product NDC
67877-771
11-digit product format
678770771
Labeler code
67877
Product ID
67877-771_40d1180e-73b5-4e73-8d42-15b99313496f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA216375
Marketing category
ANDA
Marketing start
2022-05-28
Substance
LEVETIRACETAM
Active strength
1000 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
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-771-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED50013
67877-771-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED3013
67877-771-33Levetiracetam10 in 1 BLISTER PACKTABLET, FILM COATED1013
67877-771-33Levetiracetam1 in 1 CARTONTABLET, FILM COATED113
67877-771-60Levetiracetam60 in 1 BOTTLETABLET, FILM COATED6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-771-60EA - Each67877-7713229d1e8-d138-44db-9856-58be5512aab712022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-771LEVETIRACETAM TABLET, FILM COATED [ASCEND LABORATORIES, LLC]13Current NDC, Legacy NDC, 5 package rows20241115_591dd9f1-3681-4b2f-b096-7536826e3648.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311288levETIRAcetam 250 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311289levETIRAcetam 500 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
311290levETIRAcetam 750 MG Oral TabletPSN591dd9f1-3681-4b2f-b096-7536826e364813
387003levetiracetam 1000 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311288levetiracetam 250 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311289levetiracetam 500 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813
311290levetiracetam 750 MG Oral TabletSCD591dd9f1-3681-4b2f-b096-7536826e364813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-771-0567877077105500 TABLET, FILM COATED in 1 BOTTLE (67877-771-05) 2022-05-280000-00-00NoNoCurrent
67877-771-306787707713030 TABLET, FILM COATED in 1 BOTTLE (67877-771-30) 2022-05-280000-00-00NoNoCurrent
67877-771-33678770771331 BLISTER PACK in 1 CARTON (67877-771-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-05-280000-00-00NoNoCurrent
67877-771-606787707716060 TABLET, FILM COATED in 1 BOTTLE (67877-771-60) 2022-05-280000-00-00NoNoCurrent