FDA.reportPublic FDA data

Levetiracetam

Product NDC
65862-246
11-digit product format
658620246
Labeler code
65862
Product ID
65862-246_61244070-03c7-41d1-a784-b46dfc93fcbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078993
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
500 mg/1
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
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
65862-246-05Levetiracetam500 in 1 BOTTLETABLET, FILM COATED50029
65862-246-08Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-246-05EA - Each65862-2461dff77b6-37b7-49c1-bb18-9454c042cfbe12020-02-13
65862-246-08EA - Each65862-24690f2594a-0ff4-4da8-86b6-5a0f0407dbfe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-246LEVETIRACETAM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]29Current NDC, Legacy NDC, 2 package rows20240406_2471ee03-d747-4113-86d0-1aa93c8f3eba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN2471ee03-d747-4113-86d0-1aa93c8f3eba29
311288levETIRAcetam 250 MG Oral TabletPSN2471ee03-d747-4113-86d0-1aa93c8f3eba29
311289levETIRAcetam 500 MG Oral TabletPSN2471ee03-d747-4113-86d0-1aa93c8f3eba29
311290levETIRAcetam 750 MG Oral TabletPSN2471ee03-d747-4113-86d0-1aa93c8f3eba29
387003levetiracetam 1000 MG Oral TabletSCD2471ee03-d747-4113-86d0-1aa93c8f3eba29
311288levetiracetam 250 MG Oral TabletSCD2471ee03-d747-4113-86d0-1aa93c8f3eba29
311289levetiracetam 500 MG Oral TabletSCD2471ee03-d747-4113-86d0-1aa93c8f3eba29
311290levetiracetam 750 MG Oral TabletSCD2471ee03-d747-4113-86d0-1aa93c8f3eba29
311288levETIRAcetam 250 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311289levETIRAcetam 500 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311290levETIRAcetam 750 MG Oral TabletPSNc4b27429-50a3-467c-a5ff-7e49a01a10884
311288levetiracetam 250 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884
311289levetiracetam 500 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884
311290levetiracetam 750 MG Oral TabletSCDc4b27429-50a3-467c-a5ff-7e49a01a10884
311289levETIRAcetam 500 MG Oral TabletPSN0e3aa498-ed3d-4400-b25d-12bb9a8941432
311289levETIRAcetam 500 MG Oral TabletPSN4f2642ac-703f-4447-ab2c-2c15511e5a812
311290levETIRAcetam 750 MG Oral TabletPSN4f2642ac-703f-4447-ab2c-2c15511e5a812
311289levetiracetam 500 MG Oral TabletSCD4f2642ac-703f-4447-ab2c-2c15511e5a812
311289levetiracetam 500 MG Oral TabletSCD0e3aa498-ed3d-4400-b25d-12bb9a8941432
311290levetiracetam 750 MG Oral TabletSCD4f2642ac-703f-4447-ab2c-2c15511e5a812
311289levETIRAcetam 500 MG Oral TabletPSN5eb7bea5-c95f-4a38-a5bb-c20d1549c7971
311289levETIRAcetam 500 MG Oral TabletPSN38e5c7fd-6a71-4671-bf65-bda0929a372e1
311289levetiracetam 500 MG Oral TabletSCD5eb7bea5-c95f-4a38-a5bb-c20d1549c7971
311289levetiracetam 500 MG Oral TabletSCD38e5c7fd-6a71-4671-bf65-bda0929a372e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-246-0565862024605500 TABLET, FILM COATED in 1 BOTTLE (65862-246-05) 2009-01-150000-00-00NoNoCurrent
65862-246-0865862024608120 TABLET, FILM COATED in 1 BOTTLE (65862-246-08) 2009-01-150000-00-00NoNoCurrent