FDA.reportPublic FDA data

Levetiracetam

Product NDC
50090-6086
11-digit product format
500906086
Labeler code
50090
Product ID
50090-6086_490d229e-ec98-4387-a728-b883f0b6708f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090515
Marketing category
ANDA
Marketing start
2021-11-14
Substance
LEVETIRACETAM
Active strength
1000 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui387003

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
50090-6086-0Levetiracetam30 in 1 BOTTLETABLET, FILM COATED308
50090-6086-1Levetiracetam60 in 1 BOTTLETABLET, FILM COATED608
50090-6086-2Levetiracetam180 in 1 BOTTLETABLET, FILM COATED1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6086-0EA - Each50090-60868c5af118-1bb0-4327-b32f-c45131fc744612022-10-06
50090-6086-1EA - Each50090-6086ed472a4a-93ed-460a-b40b-488170bb132212022-10-06
50090-6086-2EA - Each50090-6086ff5d1844-89e6-45d1-8e8d-d08bf31db3df12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6086LEVETIRACETAM (LEVETIRACETAM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240425_30f43d3b-c944-4f25-b5d3-009294944962.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN30f43d3b-c944-4f25-b5d3-0092949449628
387003levetiracetam 1000 MG Oral TabletSCD30f43d3b-c944-4f25-b5d3-0092949449628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6086-05009060860030 TABLET, FILM COATED in 1 BOTTLE (50090-6086-0) 2022-09-210000-00-00NoNoCurrent
50090-6086-15009060860160 TABLET, FILM COATED in 1 BOTTLE (50090-6086-1) 2022-09-210000-00-00NoNoCurrent
50090-6086-250090608602180 TABLET, FILM COATED in 1 BOTTLE (50090-6086-2) 2022-09-210000-00-00NoNoCurrent