FDA.reportPublic FDA data

Levetiracetam

Product NDC
66993-100
11-digit product format
669930100
Labeler code
66993
Product ID
66993-100_265f6517-11c1-4af8-9871-ef7fdde464e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA207958
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-01-20
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
Rxcui1736045, 1736048

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
66993-100-06Levetiracetam6 in 1 CARTONTABLET, FOR SUSPENSION63
66993-100-51Levetiracetam1 in 1 BLISTER PACKTABLET, FOR SUSPENSION13
66993-100-60Levetiracetam60 in 1 CARTONTABLET, FOR SUSPENSION603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-100-06EA - Each66993-10079aa084a-496f-404d-b4f1-425912f6019712025-02-10
66993-100-51EA - Each66993-100b10601cd-633b-4959-86b8-94e176aa46e912025-02-10
66993-100-60EA - Each66993-10037281056-0a7a-4939-be25-90039e84e2d312026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-100LEVETIRACETAM TABLET, FOR SUSPENSION [PRASCO LABORATORIES]2Current NDC, 3 package rows20250120_dd175fa3-1d7a-4542-affd-988ac5bba1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736045levETIRAcetam 250 MG Tablet for Oral SuspensionPSNdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levETIRAcetam 500 MG Tablet for Oral SuspensionPSNdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736045levetiracetam 250 MG Tablet for Oral SuspensionSCDdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levetiracetam 500 MG Tablet for Oral SuspensionSCDdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736045levetiracetam 250 MG Tablet for Oral SuspensionSYdd175fa3-1d7a-4542-affd-988ac5bba1db3
1736048levetiracetam 500 MG Tablet for Oral SuspensionSYdd175fa3-1d7a-4542-affd-988ac5bba1db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66993-100-06669930100066 BLISTER PACK in 1 CARTON (66993-100-06) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) 6 blister pack2025-01-20NoNoCurrent
66993-100-51669930100511 in 1 BLISTER PACKHistorical
66993-100-606699301006060 BLISTER PACK in 1 CARTON (66993-100-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51) 60 blister pack2026-01-16NoNoCurrent