FDA.reportPublic FDA data

Levetiracetam

Product NDC
27808-265
11-digit product format
278080265
Labeler code
27808
Product ID
27808-265_470fcaea-feb6-1488-e063-6294a90a581d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA091491
Marketing category
ANDA
Marketing start
2023-05-01
Substance
LEVETIRACETAM
Active strength
750 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
LEVETIRACETAM750 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
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
27808-265-01Levetiracetam120 in 1 BOTTLETABLET1205
27808-265-02Levetiracetam500 in 1 BOTTLETABLET5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-265LEVETIRACETAM TABLET [CRANBURY PHARMACEUTICALS, LLC]4Current NDC, 2 package rows20250319_b1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311288levETIRAcetam 250 MG Oral TabletPSNb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311289levETIRAcetam 500 MG Oral TabletPSNb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311290levETIRAcetam 750 MG Oral TabletPSNa05bbfa4-c34f-4134-8207-db79e4c704455
311290levETIRAcetam 750 MG Oral TabletPSNb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
387003levetiracetam 1000 MG Oral TabletSCDb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311288levetiracetam 250 MG Oral TabletSCDb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311289levetiracetam 500 MG Oral TabletSCDb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311290levetiracetam 750 MG Oral TabletSCDb1e988f7-8bbe-4ef4-8b0a-b2a8af8a482b5
311290levetiracetam 750 MG Oral TabletSCDa05bbfa4-c34f-4134-8207-db79e4c704455
387003levETIRAcetam 1000 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311288levETIRAcetam 250 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311289levETIRAcetam 500 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
311290levETIRAcetam 750 MG Oral TabletPSN266d4ead-fda2-f030-e063-6394a90a68e21
311290levETIRAcetam 750 MG Oral TabletPSNa3c57d82-511c-4c7d-84ff-f791f931f5761
387003levetiracetam 1000 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311288levetiracetam 250 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311289levetiracetam 500 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311290levetiracetam 750 MG Oral TabletSCDa3c57d82-511c-4c7d-84ff-f791f931f5761
311290levetiracetam 750 MG Oral TabletSCD266d4ead-fda2-f030-e063-6394a90a68e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27808-265-0127808026501120 TABLET in 1 BOTTLE (27808-265-01) 120 tablet2023-05-01NoNoCurrent
27808-265-0227808026502500 TABLET in 1 BOTTLE (27808-265-02) 500 tablet2023-05-01NoNoCurrent