FDA.reportPublic FDA data

Levetiracetam

Product NDC
17856-0574
11-digit product format
178560574
Labeler code
17856
Product ID
17856-0574_3624ffe5-0cb0-b7c0-e063-6394a90a69bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Application
ANDA203052
Marketing category
ANDA
Marketing start
2015-06-11
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levetiracetam
Brand name suffix
Levetiracetam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui403884

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
17856-0574-12024-04-08C16284748780-19d75b9cf-df31-f424-e053-dadaa90a57ceLEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
17856-0574-12023-01-30C16284748780-19d75b9cf-df31-f424-e053-dadaa90a57ceLEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
17856-0574-12021-08-25C16284748780-19d75b9cf-df31-f424-e053-dadaa90a57ceLEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999
17856-0574-12020-01-31C16284748780-19d75b9cf-df31-f424-e053-dadaa90a57ceLEVETIRACETAM ORAL SOLUTION These highlights do not include all the information needed to use LEVETIRACETAM ORAL SOLUTION safely and effectively. See full prescribing information for LEVETIRACETAM ORAL SOLUTION. LEVETIRACETAM oral solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0574-1LevetiracetamLevetiracetam72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0574-2LevetiracetamLevetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0574-1ML - Milliliter17856-05741ed00a3a-8998-4cdf-b218-a734586b1d9012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0574LEVETIRACETAM LEVETIRACETAM (LEVETIRACETAM) SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20250529_56fed03f-38c3-4273-8fd7-522bc508bf36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 100 MG/ML Oral SolutionSCD56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 100 MG per 1 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364
403884levetiracetam 500 MG per 5 ML Oral SolutionSY56fed03f-38c3-4273-8fd7-522bc508bf364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0574-11785605740172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0574-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0574-2) 2021-08-250000-00-00NoNoCurrent
17856-0574-2178560574025 mL in 1 CUP, UNIT-DOSE5 mlHistorical