FDA.reportPublic FDA data

Levetiracetam

Product NDC
60687-249
11-digit product format
606870249
Labeler code
60687
Product ID
60687-249_2e6d7924-161f-38d6-e063-6294a90aad38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203052
Marketing category
ANDA
Marketing start
2017-11-29
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
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
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-249-40Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION58
60687-249-46Levetiracetam10 in 1 TRAYSOLUTION108
60687-249-67Levetiracetam5 in 1 CASESOLUTION58
60687-249-77Levetiracetam4 in 1 CASESOLUTION48
60687-249-86Levetiracetam3 in 1 CASESOLUTION38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-249-40ML - Milliliter60687-249630b29a2-fa9b-438b-83e0-28524bd418f612018-01-12
60687-249-46ML - Milliliter60687-249fbbe3a0f-6962-4460-ad04-b34f4e0ae03012018-01-12
60687-249-67ML - Milliliter60687-24923317fe4-e4fe-46d7-be84-a6343acf9abc12017-12-14
60687-249-77ML - Milliliter60687-249dd8cc5dd-80b6-4a35-8964-35f0c5e5837112019-03-12
60687-249-86ML - Milliliter60687-249c35d862e-9209-4f0f-ab07-a8145801567712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-249LEVETIRACETAM SOLUTION [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 5 package rows20250221_3be7c30b-f35d-4dde-8bf8-24f67bd70865.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3be7c30b-f35d-4dde-8bf8-24f67bd708658
403884levetiracetam 100 MG/ML Oral SolutionSCD3be7c30b-f35d-4dde-8bf8-24f67bd708658
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3be7c30b-f35d-4dde-8bf8-24f67bd708658
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3be7c30b-f35d-4dde-8bf8-24f67bd708658
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3be7c30b-f35d-4dde-8bf8-24f67bd708658
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3be7c30b-f35d-4dde-8bf8-24f67bd708658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-249-40606870249405 mL in 1 CUP, UNIT-DOSE5 mlHistorical
60687-249-466068702494610 in 1 TRAYHistorical
60687-249-67606870249675 TRAY in 1 CASE (60687-249-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40) 5 tray2017-11-290000-00-00NoNoCurrent
60687-249-77606870249774 TRAY in 1 CASE (60687-249-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40) 4 tray2019-03-080000-00-00NoNoCurrent
60687-249-86606870249863 TRAY in 1 CASE (60687-249-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-249-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-249-40) 3 tray2023-06-15NoNoHistorical