FDA.reportPublic FDA data

Levetiracetam

Product NDC
65862-250
11-digit product format
658620250
Labeler code
65862
Product ID
65862-250_8cd74ce7-ea18-456e-bc82-34b643055e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079063
Marketing category
ANDA
Marketing start
2009-01-15
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
65862-250-05Levetiracetam500 mL in 1 BOTTLE, PLASTICSOLUTION50026
65862-250-47Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47326

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-250-47ML - Milliliter65862-250e1061a17-c5ee-4eda-bca7-ef0831df069d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-250LEVETIRACETAM SOLUTION [AUROBINDO PHARMA LIMITED]26Current NDC, Legacy NDC, 2 package rows20240918_f65ec19d-b90e-452e-b761-c68b1cf2c892.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 100 MG/ML Oral SolutionSCDf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 100 MG per 1 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
403884levetiracetam 500 MG per 5 ML Oral SolutionSYf65ec19d-b90e-452e-b761-c68b1cf2c89226
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
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 100 MG/ML Oral SolutionSCD74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 100 MG per 1 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166
403884levetiracetam 500 MG per 5 ML Oral SolutionSY74ccc9f1-b957-4b1b-9464-1b5e3318c9166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-250-0565862025005500 mL in 1 BOTTLE, PLASTIC (65862-250-05) 500 ml2009-01-150000-00-00NoNoCurrent
65862-250-4765862025047473 mL in 1 BOTTLE, PLASTIC (65862-250-47) 473 ml2009-01-150000-00-00NoNoCurrent