FDA.reportPublic FDA data

Levetiracetam

Product NDC
69339-157
11-digit product format
693390157
Labeler code
69339
Product ID
69339-157_2ec94a03-8590-4617-a6e6-782e0aae7037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA203052
Marketing category
ANDA
Marketing start
2021-01-31
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
69339-157-05Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION52
69339-157-17Levetiracetam40 in 1 BOX, UNIT-DOSESOLUTION402
69339-157-19Levetiracetam100 in 1 BOX, UNIT-DOSESOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-157-05ML - Milliliter69339-15709a7af73-139b-4db5-8dc3-a09f9ade3e6d12021-11-09
69339-157-17ML - Milliliter69339-15726f86f12-c1bc-444d-b331-5b38e410122612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-157LEVETIRACETAM SOLUTION [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 3 package rows20230902_34af3602-0188-4d2e-904b-2e40000bb45c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN34af3602-0188-4d2e-904b-2e40000bb45c2
403884levetiracetam 100 MG/ML Oral SolutionSCD34af3602-0188-4d2e-904b-2e40000bb45c2
403884levetiracetam 100 MG per 1 ML Oral SolutionSY34af3602-0188-4d2e-904b-2e40000bb45c2
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY34af3602-0188-4d2e-904b-2e40000bb45c2
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY34af3602-0188-4d2e-904b-2e40000bb45c2
403884levetiracetam 500 MG per 5 ML Oral SolutionSY34af3602-0188-4d2e-904b-2e40000bb45c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-157-05693390157055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
69339-157-176933901571740 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-17) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05) 2021-01-310000-00-00NoNoCurrent
69339-157-1969339015719100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-157-19) / 5 mL in 1 CUP, UNIT-DOSE (69339-157-05) 2021-01-310000-00-00NoNoCurrent