FDA.reportPublic FDA data

Levetiracetam

Product NDC
21695-136
11-digit product format
216950136
Labeler code
21695
Product ID
21695-136_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078858
Marketing category
ANDA
Marketing start
2009-10-15
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
750 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-136-602019-09-24C16284748780-1934fe258-4ce3-48b1-e053-8cdaa90a720aLevetiracetam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-136-60Levetiracetam60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-136-60EA - Each21695-1365b125eab-aa83-4d0c-929d-27224f8b809512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-136LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101123_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311288levETIRAcetam 250 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311289levETIRAcetam 500 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311290levETIRAcetam 750 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
387003levetiracetam 1000 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311288levetiracetam 250 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311289levetiracetam 500 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311290levetiracetam 750 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-136-602169501366060 in 1 BOTTLEHistorical