FDA.reportPublic FDA data

Levetiracetam

Product NDC
70518-3803
11-digit product format
705183803
Labeler code
70518
Product ID
70518-3803_424d104e-76be-9c39-e063-6394a90a266b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079063
Marketing category
ANDA
Marketing start
2023-07-24
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
70518-3803-0Levetiracetam10 in 1 BOXSOLUTION109
70518-3803-1Levetiracetam7.5 mL in 1 CUP, UNIT-DOSESOLUTION7.59
70518-3803-2Levetiracetam10 in 1 BOXSOLUTION109
70518-3803-3Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION59
70518-3803-4Levetiracetam10 in 1 BOXSOLUTION109
70518-3803-5Levetiracetam12.5 mL in 1 CUP, UNIT-DOSESOLUTION12.59
70518-3803-6Levetiracetam10 in 1 BOXSOLUTION109
70518-3803-7Levetiracetam20 mL in 1 BOXSOLUTION209
70518-3803-8Levetiracetam10 in 1 BOXSOLUTION109
70518-3803-9Levetiracetam15 mL in 1 CUP, UNIT-DOSESOLUTION159

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3803LEVETIRACETAM SOLUTION [REMEDYREPACK INC.]6Current NDC, 10 package rows20250521_94d042f7-93b9-43bd-9ace-cfc61903b4d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 100 MG/ML Oral SolutionSCD94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 100 MG per 1 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79
403884levetiracetam 500 MG per 5 ML Oral SolutionSY94d042f7-93b9-43bd-9ace-cfc61903b4d79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3803-07051838030010 CUP, UNIT-DOSE in 1 BOX (70518-3803-0) / 7.5 mL in 1 CUP, UNIT-DOSE (70518-3803-1) 2023-07-24NoNoHistorical
70518-3803-1705183803017.5 mL in 1 CUP, UNIT-DOSE7.5 mlHistorical
70518-3803-27051838030210 CUP, UNIT-DOSE in 1 BOX (70518-3803-2) / 5 mL in 1 CUP, UNIT-DOSE (70518-3803-3) 2023-07-24NoNoHistorical
70518-3803-3705183803035 mL in 1 CUP, UNIT-DOSE5 mlHistorical
70518-3803-47051838030410 CUP, UNIT-DOSE in 1 BOX (70518-3803-4) / 12.5 mL in 1 CUP, UNIT-DOSE (70518-3803-5) 2023-07-24NoNoHistorical
70518-3803-57051838030512.5 mL in 1 CUP, UNIT-DOSE12.5 mlHistorical
70518-3803-67051838030610 in 1 BOXHistorical
70518-3803-77051838030720 mL in 1 BOX20 mlHistorical
70518-3803-87051838030810 CUP, UNIT-DOSE in 1 BOX (70518-3803-8) / 15 mL in 1 CUP, UNIT-DOSE (70518-3803-9) 2023-07-24NoNoHistorical
70518-3803-97051838030915 mL in 1 CUP, UNIT-DOSE15 mlHistorical