FDA.reportPublic FDA data

Levetiracetam

Product NDC
68788-7884
11-digit product format
687887884
Labeler code
68788
Product ID
68788-7884_330f748b-2260-4e6d-b48d-4499bf31d561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090515
Marketing category
ANDA
Marketing start
2021-03-29
Substance
LEVETIRACETAM
Active strength
250 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
LEVETIRACETAM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288

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
68788-7884-1Levetiracetam100 in 1 BOTTLETABLET, FILM COATED1008
68788-7884-2Levetiracetam20 in 1 BOTTLETABLET, FILM COATED208
68788-7884-3Levetiracetam30 in 1 BOTTLETABLET, FILM COATED308
68788-7884-6Levetiracetam60 in 1 BOTTLETABLET, FILM COATED608
68788-7884-9Levetiracetam90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7884-1EA - Each68788-78840a531e03-d36c-441e-b115-c04b30ebddaf12021-06-02
68788-7884-2EA - Each68788-7884bb33c763-53eb-42f6-b1ab-95c14114d52412021-06-02
68788-7884-3EA - Each68788-78845dfe0f94-ce63-4366-aa35-2c5f5770ceec12021-06-02
68788-7884-6EA - Each68788-788409e42c82-04fd-40e6-b9de-025304415ef412021-06-02
68788-7884-9EA - Each68788-788455e018c8-a6b7-4d89-a2df-fe036f8595a112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7884LEVETIRACETAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20240608_419b3dba-ae21-4268-ac8b-342aaa609554.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSN419b3dba-ae21-4268-ac8b-342aaa6095548
311288levetiracetam 250 MG Oral TabletSCD419b3dba-ae21-4268-ac8b-342aaa6095548

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7884-168788788401100 TABLET, FILM COATED in 1 BOTTLE (68788-7884-1) 2021-03-290000-00-00NoNoCurrent
68788-7884-26878878840220 TABLET, FILM COATED in 1 BOTTLE (68788-7884-2) 2021-03-290000-00-00NoNoCurrent
68788-7884-36878878840330 TABLET, FILM COATED in 1 BOTTLE (68788-7884-3) 2021-03-290000-00-00NoNoCurrent
68788-7884-66878878840660 TABLET, FILM COATED in 1 BOTTLE (68788-7884-6) 2021-03-290000-00-00NoNoCurrent
68788-7884-96878878840990 TABLET, FILM COATED in 1 BOTTLE (68788-7884-9) 2021-03-290000-00-00NoNoCurrent