Levetiracetam

Product NDC
71093-144
11-digit product format
710930144
Labeler code
71093
Product ID
71093-144_ee070736-c3ee-4946-97aa-5b431173034b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA078582
Marketing category
ANDA
Marketing start
2009-01-15
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
71093-144-13Levetiracetam473 mL in 1 BOTTLESOLUTION4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-144LEVETIRACETAM SOLUTION [ACI HEALTHCARE USA, INC.]6Legacy NDC, 1 package rows20231217_e5939df6-0b5f-4772-b2aa-2db92a1e8814.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levetiracetam 100 MG/ML Oral SolutionSCDf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levetiracetam 100 MG per 1 ML Oral SolutionSYf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levetiracetam 500 MG per 5 ML Oral SolutionSYf7c96494-6cb2-4d00-8c5a-5bec4e0c70c0102
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNe5939df6-0b5f-4772-b2aa-2db92a1e88146
403884levetiracetam 100 MG/ML Oral SolutionSCDe5939df6-0b5f-4772-b2aa-2db92a1e88146
403884levetiracetam 100 MG per 1 ML Oral SolutionSYe5939df6-0b5f-4772-b2aa-2db92a1e88146
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYe5939df6-0b5f-4772-b2aa-2db92a1e88146
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYe5939df6-0b5f-4772-b2aa-2db92a1e88146
403884levetiracetam 500 MG per 5 ML Oral SolutionSYe5939df6-0b5f-4772-b2aa-2db92a1e88146

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-144-1371093014413473 mL in 1 BOTTLE (71093-144-13) 473 ml2009-01-150000-00-00NoNoCurrent