FDA.reportPublic FDA data

Spritam

Product NDC
43485-104
11-digit product format
434850104
Labeler code
43485
Product ID
43485-104_890ef534-7363-4f2b-b125-8f62e2eb26d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Aprecia Pharmaceuticals, LLC
Application
NDA207958
Marketing category
NDA
Marketing start
2016-02-05
Marketing end
2028-06-30
Substance
LEVETIRACETAM
Active strength
1000 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spritam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui1736037, 1736044, 1736045, 1736047, 1736048, 1736050, 1736051, 1736053

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
43485-104-01Spritam1 in 1 BLISTER PACKTABLET, FOR SUSPENSION129
43485-104-60Spritam60 in 1 CARTONTABLET, FOR SUSPENSION6029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43485-104-01EA - Each43485-10492240441-e359-41df-ba55-87c4a1b095c712016-03-04
43485-104-60EA - Each43485-1046a400f90-69c1-445f-80d4-1e03d6a14a7812016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43485-104SPRITAM (LEVETIRACETAM) TABLET, FOR SUSPENSION [APRECIA PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 2 package rows20241222_be651c31-383f-11e4-916c-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736037levETIRAcetam 1000 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736045levETIRAcetam 250 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736048levETIRAcetam 500 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736051levETIRAcetam 750 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736044Spritam 1000 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736047Spritam 250 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736050Spritam 500 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736053Spritam 750 MG Tablet for Oral SuspensionPSNbe651c31-383f-11e4-916c-0800200c9a6629
1736044levetiracetam 1000 MG Tablet for Oral Suspension [Spritam]SBDbe651c31-383f-11e4-916c-0800200c9a6629
1736047levetiracetam 250 MG Tablet for Oral Suspension [Spritam]SBDbe651c31-383f-11e4-916c-0800200c9a6629
1736050levetiracetam 500 MG Tablet for Oral Suspension [Spritam]SBDbe651c31-383f-11e4-916c-0800200c9a6629
1736053levetiracetam 750 MG Tablet for Oral Suspension [Spritam]SBDbe651c31-383f-11e4-916c-0800200c9a6629
1736037levetiracetam 1000 MG Tablet for Oral SuspensionSCDbe651c31-383f-11e4-916c-0800200c9a6629
1736045levetiracetam 250 MG Tablet for Oral SuspensionSCDbe651c31-383f-11e4-916c-0800200c9a6629
1736048levetiracetam 500 MG Tablet for Oral SuspensionSCDbe651c31-383f-11e4-916c-0800200c9a6629
1736051levetiracetam 750 MG Tablet for Oral SuspensionSCDbe651c31-383f-11e4-916c-0800200c9a6629
1736037levetiracetam 1000 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736045levetiracetam 250 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736048levetiracetam 500 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736051levetiracetam 750 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736044Spritam 1000 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736047Spritam 250 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736050Spritam 500 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629
1736053Spritam 750 MG Tablet for Oral SuspensionSYbe651c31-383f-11e4-916c-0800200c9a6629

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43485-104-01434850104011 in 1 BLISTER PACKHistorical
43485-104-604348501046060 BLISTER PACK in 1 CARTON (43485-104-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-104-01) 60 blister pack2016-02-052028-06-30NoNoCurrent