FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
81033-013
11-digit product format
810330013
Labeler code
81033
Product ID
81033-013_30a4626d-74f4-6385-e063-6394a90a2950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA079120
Marketing category
ANDA
Marketing start
2024-07-18
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-013-05LEVETIRACETAM5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-013-50LEVETIRACETAM50 in 1 CARTONSOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-013-05ML - Milliliter81033-01346a32d60-e6ad-48f0-8b46-0e4b5e4e83b012025-05-14
81033-013-50ML - Milliliter81033-0133e11fdfd-26a1-4aad-bc65-4952bc91392712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-013LEVETIRACETAM SOLUTION [KESIN PHARMA CORPORATION]1Current NDC, 2 package rows20250326_30a4626d-74f3-6385-e063-6394a90a2950.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN30a4626d-74f3-6385-e063-6394a90a29501
403884levetiracetam 100 MG/ML Oral SolutionSCD30a4626d-74f3-6385-e063-6394a90a29501
403884levetiracetam 100 MG per 1 ML Oral SolutionSY30a4626d-74f3-6385-e063-6394a90a29501
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY30a4626d-74f3-6385-e063-6394a90a29501
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY30a4626d-74f3-6385-e063-6394a90a29501
403884levetiracetam 500 MG per 5 ML Oral SolutionSY30a4626d-74f3-6385-e063-6394a90a29501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-013-05810330013055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-013-508103300135050 CUP, UNIT-DOSE in 1 CARTON (81033-013-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-013-05) 2025-03-01NoNoCurrent