FDA.reportPublic FDA data

Levetiracetam

Product NDC
63739-158
11-digit product format
637390158
Labeler code
63739
Product ID
63739-158_cfa2687a-92d1-4da7-ae11-c1e322bd8176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA201157
Marketing category
ANDA
Marketing start
2022-07-01
Marketing end
2026-06-30
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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
Levetiracetam

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
63739-158-32Levetiracetam10 in 1 TRAYSOLUTION108
63739-158-32Levetiracetam4 in 1 CASESOLUTION48
63739-158-70Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION58
63739-158-78Levetiracetam3 in 1 CASESOLUTION38
63739-158-78Levetiracetam10 in 1 TRAYSOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-158-32ML - Milliliter63739-15881ba70d7-503f-46a3-b2b0-0f1361f5cfa212022-08-04
63739-158-70ML - Milliliter63739-15879d0de9b-28bb-46fe-b894-64f114f0f66b12022-08-04
63739-158-78ML - Milliliter63739-15834032009-bf2b-4831-9d4f-245d23ef7ac112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-158LEVETIRACETAM SOLUTION [MCKESSON CORPORATION DBA SKY PACKAGING]8Current NDC, Legacy NDC, 5 package rows20250308_7a0d7f05-e091-4d9b-93f5-fd2c7f728a83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN7a0d7f05-e091-4d9b-93f5-fd2c7f728a838
403884levetiracetam 100 MG/ML Oral SolutionSCD7a0d7f05-e091-4d9b-93f5-fd2c7f728a838
403884levetiracetam 100 MG per 1 ML Oral SolutionSY7a0d7f05-e091-4d9b-93f5-fd2c7f728a838
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY7a0d7f05-e091-4d9b-93f5-fd2c7f728a838
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY7a0d7f05-e091-4d9b-93f5-fd2c7f728a838
403884levetiracetam 500 MG per 5 ML Oral SolutionSY7a0d7f05-e091-4d9b-93f5-fd2c7f728a838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-158-32637390158324 TRAY in 1 CASE (63739-158-32) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70) 4 tray2022-07-012026-06-30NoNoCurrent
63739-158-70637390158705 mL in 1 CUP, UNIT-DOSE5 mlHistorical
63739-158-78637390158783 TRAY in 1 CASE (63739-158-78) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (63739-158-70) 3 tray2023-05-012026-06-30NoNoHistorical