FDA.reportPublic FDA data

Levetiracetam

Product NDC
39328-511
11-digit product format
393280511
Labeler code
39328
Product ID
39328-511_6e8da622-1edb-4ca7-8b48-b77d580246e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Patrin Pharma, Inc.
Application
ANDA078582
Marketing category
ANDA
Marketing start
2024-01-31
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
39328-511-05Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION51
39328-511-30Levetiracetam3 in 1 CASESOLUTION31
39328-511-30Levetiracetam10 in 1 TRAYSOLUTION101
39328-511-40Levetiracetam4 in 1 CASESOLUTION41
39328-511-40Levetiracetam10 in 1 TRAYSOLUTION101
39328-511-50Levetiracetam5 in 1 CASESOLUTION51
39328-511-50Levetiracetam10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-511-05ML - Milliliter39328-511ceca9e53-957f-4d4f-8a52-a2e379b420f512024-04-05
39328-511-30ML - Milliliter39328-51160870472-69ee-456a-93fa-4c13f292cae112024-04-05
39328-511-40ML - Milliliter39328-5119d956be1-ec8f-4284-a9fd-8a81e1ca0d1112024-04-05
39328-511-50ML - Milliliter39328-5116354f794-b5c4-4e13-abc4-0c37235ae0f712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-511LEVETIRACETAM SOLUTION [PATRIN PHARMA, INC.]1Current NDC, 7 package rows20240217_49117cee-a96c-4593-91a7-8a133e3f0939.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN49117cee-a96c-4593-91a7-8a133e3f09391
403884levetiracetam 100 MG/ML Oral SolutionSCD49117cee-a96c-4593-91a7-8a133e3f09391
403884levetiracetam 100 MG per 1 ML Oral SolutionSY49117cee-a96c-4593-91a7-8a133e3f09391
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY49117cee-a96c-4593-91a7-8a133e3f09391
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY49117cee-a96c-4593-91a7-8a133e3f09391
403884levetiracetam 500 MG per 5 ML Oral SolutionSY49117cee-a96c-4593-91a7-8a133e3f09391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39328-511-05393280511055 mL in 1 CUP, UNIT-DOSE (39328-511-05) 5 ml2024-01-31NoNoHistorical
39328-511-30393280511303 TRAY in 1 CASE (39328-511-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE3 tray2024-01-31NoNoHistorical
39328-511-40393280511404 TRAY in 1 CASE (39328-511-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE4 tray2024-01-31NoNoHistorical
39328-511-50393280511505 TRAY in 1 CASE (39328-511-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE5 tray2024-01-31NoNoHistorical