FDA.reportPublic FDA data

Levetiracetam

Product NDC
0904-7265
11-digit product format
009047265
Labeler code
0904
Product ID
0904-7265_0253fb34-3555-4f12-9442-0a9be7bb6878
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA201157
Marketing category
ANDA
Marketing start
2015-06-04
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
0904-7265-41Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION55
0904-7265-92Levetiracetam5 in 1 CASESOLUTION55
0904-7265-92Levetiracetam10 in 1 TRAYSOLUTION105
0904-7265-93Levetiracetam10 in 1 TRAYSOLUTION105
0904-7265-93Levetiracetam3 in 1 CASESOLUTION35
0904-7265-94Levetiracetam10 in 1 TRAYSOLUTION105
0904-7265-94Levetiracetam4 in 1 CASESOLUTION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7265-41ML - Milliliter0904-72652981915a-0651-4cc2-8fb5-bc926fa5a51f12022-12-07
0904-7265-92ML - Milliliter0904-72658a10c0aa-3daf-4a59-9bd6-36cf708c90ef12022-12-07
0904-7265-93ML - Milliliter0904-726598f467fa-a2eb-4485-839e-82542c14879a12022-12-07
0904-7265-94ML - Milliliter0904-7265cc65c450-6590-4cf2-b38a-88496d4ccd4812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7265LEVETIRACETAM SOLUTION [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 7 package rows20240127_423d2185-0931-4414-8864-7594000809ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN423d2185-0931-4414-8864-7594000809ee5
403884levetiracetam 100 MG/ML Oral SolutionSCD423d2185-0931-4414-8864-7594000809ee5
403884levetiracetam 100 MG per 1 ML Oral SolutionSY423d2185-0931-4414-8864-7594000809ee5
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY423d2185-0931-4414-8864-7594000809ee5
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY423d2185-0931-4414-8864-7594000809ee5
403884levetiracetam 500 MG per 5 ML Oral SolutionSY423d2185-0931-4414-8864-7594000809ee5
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNa91defd2-486b-4995-ba4c-640525ab575d3
403884levetiracetam 100 MG/ML Oral SolutionSCDa91defd2-486b-4995-ba4c-640525ab575d3
403884levetiracetam 100 MG per 1 ML Oral SolutionSYa91defd2-486b-4995-ba4c-640525ab575d3
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYa91defd2-486b-4995-ba4c-640525ab575d3
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYa91defd2-486b-4995-ba4c-640525ab575d3
403884levetiracetam 500 MG per 5 ML Oral SolutionSYa91defd2-486b-4995-ba4c-640525ab575d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7265-41009047265415 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0904-7265-92009047265925 TRAY in 1 CASE (0904-7265-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) 5 tray2022-11-210000-00-00NoNoCurrent
0904-7265-93009047265933 TRAY in 1 CASE (0904-7265-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) 3 tray2022-11-210000-00-00NoNoCurrent
0904-7265-94009047265944 TRAY in 1 CASE (0904-7265-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7265-41) 4 tray2022-11-210000-00-00NoNoCurrent