FDA.reportPublic FDA data

Levetiracetam

Product NDC
0378-5615
11-digit product format
003785615
Labeler code
0378
Product ID
0378-5615_8eaa3318-fe96-4d3e-9f49-3286cb04bfbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076919
Marketing category
ANDA
Marketing start
2008-11-04
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
Rxcui311289, 311290, 387003

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
0378-5615-05Levetiracetam500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50041
0378-5615-78Levetiracetam120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5615-05EA - Each0378-56157f134995-63cc-4fb8-b3e5-12905634549e12012-07-24
0378-5615-07EA - Each0378-5615f660511c-c967-4caf-9a03-8d9658cd1e8f12013-02-13
0378-5615-12EA - Each0378-561581639b71-4b94-4bc1-bfea-9deb5d61ac2212013-02-13
0378-5615-78EA - Each0378-5615adb6ca6e-bb97-4abe-b59f-df36767ecefa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]16
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]5
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5615LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]38Current NDC, Legacy NDC, 2 package rows20241011_0a987d59-560f-4650-96ec-31aec81953b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN0a987d59-560f-4650-96ec-31aec81953b541
311289levETIRAcetam 500 MG Oral TabletPSN0a987d59-560f-4650-96ec-31aec81953b541
311290levETIRAcetam 750 MG Oral TabletPSN0a987d59-560f-4650-96ec-31aec81953b541
387003levetiracetam 1000 MG Oral TabletSCD0a987d59-560f-4650-96ec-31aec81953b541
311289levetiracetam 500 MG Oral TabletSCD0a987d59-560f-4650-96ec-31aec81953b541
311290levetiracetam 750 MG Oral TabletSCD0a987d59-560f-4650-96ec-31aec81953b541
311289levETIRAcetam 500 MG Oral TabletPSN08e1bfea-7f3f-42d9-823d-f75080e664ff17
311289levetiracetam 500 MG Oral TabletSCD08e1bfea-7f3f-42d9-823d-f75080e664ff17
311289levETIRAcetam 500 MG Oral TabletPSNe72a7410-13fd-40e4-befb-052d0455e0383
311289levetiracetam 500 MG Oral TabletSCDe72a7410-13fd-40e4-befb-052d0455e0383
311289levETIRAcetam 500 MG Oral TabletPSN97d9d2b7-745b-413e-a7ba-8ebe207a463f1
311289levetiracetam 500 MG Oral TabletSCD97d9d2b7-745b-413e-a7ba-8ebe207a463f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-5615-0500378561505500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-05) 2008-11-040000-00-00NoNoCurrent
0378-5615-7800378561578120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-78) 2008-11-040000-00-00NoNoCurrent