FDA.reportPublic FDA data

levetiracetam

Product NDC
0904-7420
11-digit product format
009047420
Labeler code
0904
Product ID
0904-7420_6913c611-4994-4501-8ed9-45161f90373e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
ANDA214757
Marketing category
ANDA
Marketing start
2022-07-16
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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
LEVETIRACETAM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui403884

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
0904-7420-16levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7420-16ML - Milliliter0904-7420768f049d-d75c-42c9-a2ac-d242f1e4cbdf12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7420LEVETIRACETAM SOLUTION [MAJOR PHARMACEUTICALS]1Current NDC, 1 package rows20240107_6913c611-4994-4501-8ed9-45161f90373e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN6913c611-4994-4501-8ed9-45161f90373e1
403884levetiracetam 100 MG/ML Oral SolutionSCD6913c611-4994-4501-8ed9-45161f90373e1
403884levetiracetam 100 MG per 1 ML Oral SolutionSY6913c611-4994-4501-8ed9-45161f90373e1
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY6913c611-4994-4501-8ed9-45161f90373e1
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY6913c611-4994-4501-8ed9-45161f90373e1
403884levetiracetam 500 MG per 5 ML Oral SolutionSY6913c611-4994-4501-8ed9-45161f90373e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7420-1600904742016473 mL in 1 BOTTLE, PLASTIC (0904-7420-16) 473 ml2024-01-05NoNoCurrent