FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
10135-695
11-digit product format
101350695
Labeler code
10135
Product ID
10135-695_f519081c-230f-4a77-a80d-28e2f7d163df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA078582
Marketing category
ANDA
Marketing start
2020-03-01
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
2021-12-31
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-695-082022-01-28C16284748780-1d6a99b39-d5df-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use LEVETIRACETAM o ral s olution, USP safely and effectively. See full prescribing information for L EVETIRACETAM o ral s olution, USP . LEVETIRACETAM oral solution, USP Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-695-08LEVETIRACETAM473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-695-08ML - Milliliter10135-6958e9458f5-1e9d-47a5-9a2f-e053331d6d7512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-695LEVETIRACETAM SOLUTION [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20200404_59eb1819-529d-466e-967b-50e7ab1988de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN59eb1819-529d-466e-967b-50e7ab1988de1
403884levetiracetam 100 MG/ML Oral SolutionSCD59eb1819-529d-466e-967b-50e7ab1988de1
403884levetiracetam 100 MG per 1 ML Oral SolutionSY59eb1819-529d-466e-967b-50e7ab1988de1
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY59eb1819-529d-466e-967b-50e7ab1988de1
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY59eb1819-529d-466e-967b-50e7ab1988de1
403884levetiracetam 500 MG per 5 ML Oral SolutionSY59eb1819-529d-466e-967b-50e7ab1988de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-695-0810135069508473 mL in 1 BOTTLE, PLASTIC (10135-695-08) 473 ml2020-03-010000-00-00NoNoCurrent