FDA.reportPublic FDA data

Levetiracetam

Product NDC
68788-8843
11-digit product format
687888843
Labeler code
68788
Product ID
68788-8843_8c16bc7b-672c-420a-a457-350060533375
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091491
Marketing category
ANDA
Marketing start
2025-03-20
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
68788-8843-1Levetiracetam100 in 1 BOTTLETABLET1001
68788-8843-2Levetiracetam20 in 1 BOTTLETABLET201
68788-8843-3Levetiracetam30 in 1 BOTTLETABLET301
68788-8843-6Levetiracetam60 in 1 BOTTLETABLET601
68788-8843-9Levetiracetam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8843-1EA - Each68788-8843ba745c81-4212-4836-944d-485ff08fa2a012025-05-14
68788-8843-2EA - Each68788-884373858f29-890c-4f90-8afd-dea3b2dfab4612025-05-14
68788-8843-3EA - Each68788-8843fe4f097f-20ab-4238-914b-a1462776d27412025-05-14
68788-8843-6EA - Each68788-884395cfbfa9-f3b6-4dc8-9fb4-8e616268bcdc12025-05-14
68788-8843-9EA - Each68788-88437da3251d-301b-4cb6-9d24-a13b272d961e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8843LEVETIRACETAM TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250322_8c16bc7b-672c-420a-a457-350060533375.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN8c16bc7b-672c-420a-a457-3500605333751
311289levetiracetam 500 MG Oral TabletSCD8c16bc7b-672c-420a-a457-3500605333751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8843-168788884301100 TABLET in 1 BOTTLE (68788-8843-1) 100 tablet2025-03-20NoNoHistorical
68788-8843-26878888430220 TABLET in 1 BOTTLE (68788-8843-2) 20 tablet2025-03-20NoNoHistorical
68788-8843-36878888430330 TABLET in 1 BOTTLE (68788-8843-3) 30 tablet2025-03-20NoNoHistorical
68788-8843-66878888430660 TABLET in 1 BOTTLE (68788-8843-6) 60 tablet2025-03-20NoNoHistorical
68788-8843-96878888430990 TABLET in 1 BOTTLE (68788-8843-9) 90 tablet2025-03-20NoNoHistorical