FDA.reportPublic FDA data

Keppra

Product NDC
50474-595
11-digit product format
504740595
Labeler code
50474
Product ID
50474-595_4974b225-87ca-610e-e063-6294a90ad20a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
UCB, Inc.
Application
NDA021035
Marketing category
NDA
Marketing start
2000-04-24
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Keppra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, 404595, 630807

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-595-40Keppra120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-595-40EA - Each50474-595ea4c1ad5-3d93-408c-a757-362808ffa95f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levetiracetamACTIVE INGREDIENT44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
levetiracetamACTIVE MOIETY44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
aluminum oxideINACTIVE INGREDIENTLMI26O6933KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
ammonium glycyrrhizateINACTIVE INGREDIENT3VRD35U26CKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
ferric oxide redINACTIVE INGREDIENT1K09F3G675KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
glycerinINACTIVE INGREDIENTPDC6A3C0OXKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
indigotindisulfonate sodiumINACTIVE INGREDIENTD3741U8K7LKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
magnesium stearateINACTIVE INGREDIENT70097M6I30KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
methylparabenINACTIVE INGREDIENTA2I8C7HI9TKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
polyvinyl alcoholINACTIVE INGREDIENT532B59J990KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
talcINACTIVE INGREDIENT7SEV7J4R1UKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
waterINACTIVE INGREDIENT059QF0KO0RKEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]16
levetiracetamACTIVE INGREDIENT44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
levetiracetamACTIVE MOIETY44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
aluminum oxideINACTIVE INGREDIENTLMI26O6933KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
polyvinyl alcoholINACTIVE INGREDIENT532B59J990KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LEVETIRACETAMACTIVE INGREDIENT44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
LEVETIRACETAMACTIVE MOIETY44YRR34555KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKEPPRA (LEVETIRACETAM) TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-595KEPPRA (LEVETIRACETAM) TABLET, FILM COATED KEPPRA (LEVETIRACETAM) SOLUTION [UCB, INC.]32Current NDC, Legacy NDC, 1 package rows20240430_3ca9df05-a506-4ec8-a4fe-320f1219ab21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404595Keppra 100 MG in 1 mL Oral SolutionPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
630807Keppra 1000 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261335Keppra 250 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261336Keppra 500 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
284391Keppra 750 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
387003levETIRAcetam 1000 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311288levETIRAcetam 250 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311289levETIRAcetam 500 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311290levETIRAcetam 750 MG Oral TabletPSN3ca9df05-a506-4ec8-a4fe-320f1219ab2136
404595levetiracetam 100 MG/ML Oral Solution [Keppra]SBD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
630807levetiracetam 1000 MG Oral Tablet [Keppra]SBD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261335levetiracetam 250 MG Oral Tablet [Keppra]SBD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261336levetiracetam 500 MG Oral Tablet [Keppra]SBD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
284391levetiracetam 750 MG Oral Tablet [Keppra]SBD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levetiracetam 100 MG/ML Oral SolutionSCD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
387003levetiracetam 1000 MG Oral TabletSCD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311288levetiracetam 250 MG Oral TabletSCD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311289levetiracetam 500 MG Oral TabletSCD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
311290levetiracetam 750 MG Oral TabletSCD3ca9df05-a506-4ec8-a4fe-320f1219ab2136
404595Keppra 100 MG per 1 ML Oral SolutionSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
630807Keppra 1000 MG Oral TabletSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261335Keppra 250 MG Oral TabletSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261336Keppra 500 MG Oral TabletSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
284391Keppra 750 MG Oral TabletSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3ca9df05-a506-4ec8-a4fe-320f1219ab2136
261336Keppra 500 MG Oral TabletPSN746aa1a9-4605-4991-bb80-62685284bb0b3
284391Keppra 750 MG Oral TabletPSN746aa1a9-4605-4991-bb80-62685284bb0b3
311289levETIRAcetam 500 MG Oral TabletPSN746aa1a9-4605-4991-bb80-62685284bb0b3
311290levETIRAcetam 750 MG Oral TabletPSN746aa1a9-4605-4991-bb80-62685284bb0b3
261336levetiracetam 500 MG Oral Tablet [Keppra]SBD746aa1a9-4605-4991-bb80-62685284bb0b3
284391levetiracetam 750 MG Oral Tablet [Keppra]SBD746aa1a9-4605-4991-bb80-62685284bb0b3
311289levetiracetam 500 MG Oral TabletSCD746aa1a9-4605-4991-bb80-62685284bb0b3
311290levetiracetam 750 MG Oral TabletSCD746aa1a9-4605-4991-bb80-62685284bb0b3
261336Keppra 500 MG Oral TabletSY746aa1a9-4605-4991-bb80-62685284bb0b3
284391Keppra 750 MG Oral TabletSY746aa1a9-4605-4991-bb80-62685284bb0b3
261336Keppra 500 MG Oral TabletPSN7b1d9124-5fde-4f57-9fca-ee061750fcc31
284391Keppra 750 MG Oral TabletPSN7b1d9124-5fde-4f57-9fca-ee061750fcc31
311289levETIRAcetam 500 MG Oral TabletPSN7b1d9124-5fde-4f57-9fca-ee061750fcc31
311290levETIRAcetam 750 MG Oral TabletPSN7b1d9124-5fde-4f57-9fca-ee061750fcc31
261336levetiracetam 500 MG Oral Tablet [Keppra]SBD7b1d9124-5fde-4f57-9fca-ee061750fcc31
284391levetiracetam 750 MG Oral Tablet [Keppra]SBD7b1d9124-5fde-4f57-9fca-ee061750fcc31
311289levetiracetam 500 MG Oral TabletSCD7b1d9124-5fde-4f57-9fca-ee061750fcc31
311290levetiracetam 750 MG Oral TabletSCD7b1d9124-5fde-4f57-9fca-ee061750fcc31
261336Keppra 500 MG Oral TabletSY7b1d9124-5fde-4f57-9fca-ee061750fcc31
284391Keppra 750 MG Oral TabletSY7b1d9124-5fde-4f57-9fca-ee061750fcc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50474-595-4050474059540120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40) 2000-04-240000-00-00NoNoCurrent