FDA.reportPublic FDA data

Levetiracetam

Product NDC
68788-8254
11-digit product format
687888254
Labeler code
68788
Product ID
68788-8254_dbbfc67e-e438-40f9-bbee-56f0d0e25a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078154
Marketing category
ANDA
Marketing start
2022-09-02
Substance
LEVETIRACETAM
Active strength
500 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
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

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
68788-8254-1Levetiracetam100 in 1 BOTTLETABLET, FILM COATED1004
68788-8254-2Levetiracetam20 in 1 BOTTLETABLET, FILM COATED204
68788-8254-3Levetiracetam30 in 1 BOTTLETABLET, FILM COATED304
68788-8254-6Levetiracetam60 in 1 BOTTLETABLET, FILM COATED604
68788-8254-9Levetiracetam90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8254-1EA - Each68788-8254f724e649-31a6-4fcf-972a-642c93c8077412022-10-06
68788-8254-2EA - Each68788-8254b265081d-10cc-40cf-9b00-6594a4e5c2f512022-10-06
68788-8254-3EA - Each68788-82547b50e9e8-65a6-44dc-84e8-296a0ccb7e8612022-10-06
68788-8254-6EA - Each68788-82548a214fc7-17ef-4146-a2b4-1f0fdba9050112022-10-06
68788-8254-9EA - Each68788-8254630f4653-ed7e-49be-b954-b40aaae7cf7b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8254LEVETIRACETAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 5 package rows20240709_e31c6830-4647-4481-b4f1-494a52c48b1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSNe31c6830-4647-4481-b4f1-494a52c48b1b4
311289levetiracetam 500 MG Oral TabletSCDe31c6830-4647-4481-b4f1-494a52c48b1b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8254-168788825401100 TABLET, FILM COATED in 1 BOTTLE (68788-8254-1) 2022-09-020000-00-00NoNoCurrent
68788-8254-26878882540220 TABLET, FILM COATED in 1 BOTTLE (68788-8254-2) 2022-09-020000-00-00NoNoCurrent
68788-8254-36878882540330 TABLET, FILM COATED in 1 BOTTLE (68788-8254-3) 2022-09-020000-00-00NoNoCurrent
68788-8254-66878882540660 TABLET, FILM COATED in 1 BOTTLE (68788-8254-6) 2022-09-020000-00-00NoNoCurrent
68788-8254-96878882540990 TABLET, FILM COATED in 1 BOTTLE (68788-8254-9) 2022-09-020000-00-00NoNoCurrent