FDA.reportPublic FDA data

Levetiracetam

Product NDC
70518-1901
11-digit product format
705181901
Labeler code
70518
Product ID
70518-1901_4987ad82-cd46-45b0-e063-6394a90af127
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090515
Marketing category
ANDA
Marketing start
2019-02-22
Substance
LEVETIRACETAM
Active strength
1000 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
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui387003

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1901-02023-03-07C16284748780-1f386c64a-3e82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-12023-03-07C16284748780-1f386c64a-3e82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-02023-01-30C16284748780-1f386c64a-3e82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999
70518-1901-12023-01-30C16284748780-1f386c64a-3e82-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVETIRACETAM TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1901-0Levetiracetam30 in 1 BLISTER PACKTABLET, FILM COATED3014
70518-1901-1Levetiracetam30 in 1 BOXTABLET, FILM COATED3014
70518-1901-2Levetiracetam1 in 1 POUCHTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1901LEVETIRACETAM TABLET, FILM COATED [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 3 package rows20250424_ae405796-1eca-4890-bcb2-e1b07654a24d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNae405796-1eca-4890-bcb2-e1b07654a24d14
387003levetiracetam 1000 MG Oral TabletSCDae405796-1eca-4890-bcb2-e1b07654a24d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1901-07051819010030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1901-0) 2019-02-220000-00-00NoNoCurrent
70518-1901-17051819010130 POUCH in 1 BOX (70518-1901-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1901-2) 30 pouch2021-08-040000-00-00NoNoCurrent
70518-1901-2705181901021 in 1 POUCHHistorical