Levetiracetam

Product NDC
81646-116
11-digit product format
816460116
Labeler code
81646
Product ID
81646-116_a279dd0a-b4f9-4b28-8d1c-1c4d58fefa7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
PINNACLE PHARMA LLC
Application
ANDA201157
Marketing category
ANDA
Marketing start
2015-06-04
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81646-116-05Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81646-116LEVETIRACETAM SOLUTION [PINNACLE PHARMA LLC]2Legacy NDC, 1 package rows20210515_3a472ddb-ecde-4d51-adbc-d95a96cf85d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 100 MG/ML Oral SolutionSCD3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3a472ddb-ecde-4d51-adbc-d95a96cf85d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81646-116-05816460116055 mL in 1 CUP, UNIT-DOSE (81646-116-05) 5 ml2015-06-040000-00-00NoNoCurrent