LEVETIRACETAM solution

Product NDC
68999-548
11-digit product format
689990548
Labeler code
68999
Product ID
68999-548_4357753b-846a-c5ea-e063-6394a90aa1ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA090263
Marketing category
ANDA
Marketing start
2009-04-03
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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 solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui403884

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
68999-548-24LEVETIRACETAM solution2 in 1 BOXSOLUTION21
68999-548-24LEVETIRACETAM solution10 in 1 TRAYSOLUTION101
68999-548-45LEVETIRACETAM solution5 mL in 1 CUPSOLUTION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNe1ebd960-79a4-4632-b727-4e98118241131
403884levetiracetam 100 MG/ML Oral SolutionSCDe1ebd960-79a4-4632-b727-4e98118241131
403884levetiracetam 100 MG per 1 ML Oral SolutionSYe1ebd960-79a4-4632-b727-4e98118241131
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYe1ebd960-79a4-4632-b727-4e98118241131
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYe1ebd960-79a4-4632-b727-4e98118241131
403884levetiracetam 500 MG per 5 ML Oral SolutionSYe1ebd960-79a4-4632-b727-4e98118241131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-548-24689990548242 TRAY in 1 BOX (68999-548-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-548-45) 2 tray2025-10-29NoNoHistorical
68999-548-45689990548455 mL in 1 CUP5 mlHistorical