Levetiracetam

Product NDC
13668-014
11-digit product format
136680014
Labeler code
13668
Product ID
13668-014_b8792837-f86a-4e67-b1a5-ec8ca278fe77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA078858
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
250 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
LEVETIRACETAM250 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
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
13668-014-05Levetiracetam500 in 1 BOTTLETABLET50027
13668-014-12Levetiracetam120 in 1 BOTTLETABLET12027
13668-014-25Levetiracetam250 in 1 BOTTLETABLET25027
13668-014-31Levetiracetam2500 in 1 BOTTLETABLET250027
13668-014-60Levetiracetam60 in 1 BOTTLETABLET6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-014-05EA - Each13668-014f25a0b12-fddd-49c7-b3a2-a8cf6bb3785612012-07-24
13668-014-12EA - Each13668-014f445e1db-97de-4359-9068-d28cec95d35812012-07-24
13668-014-25EA - Each13668-014d34b3b20-b848-468e-8a8e-eaf77dda0cbb12012-07-24
13668-014-60EA - Each13668-014a6ad045f-3f57-4566-991b-1c2ec9d03b3e12012-07-24
13668-014-77EA - Each13668-0149adb1dfa-d710-40d3-b231-8cb8d32c965a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]13
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [STAT RX USA LLC]3
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [STAT RX USA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-014LEVETIRACETAM TABLET [TORRENT PHARMACEUTICALS LIMITED]27Current NDC, Legacy NDC, 5 package rows20250201_6ab24168-058d-496e-9023-da8ee6353eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSN6ab24168-058d-496e-9023-da8ee6353eb327
311288levETIRAcetam 250 MG Oral TabletPSN6ab24168-058d-496e-9023-da8ee6353eb327
311289levETIRAcetam 500 MG Oral TabletPSN6ab24168-058d-496e-9023-da8ee6353eb327
311290levETIRAcetam 750 MG Oral TabletPSN6ab24168-058d-496e-9023-da8ee6353eb327
387003levetiracetam 1000 MG Oral TabletSCD6ab24168-058d-496e-9023-da8ee6353eb327
311288levetiracetam 250 MG Oral TabletSCD6ab24168-058d-496e-9023-da8ee6353eb327
311289levetiracetam 500 MG Oral TabletSCD6ab24168-058d-496e-9023-da8ee6353eb327
311290levetiracetam 750 MG Oral TabletSCD6ab24168-058d-496e-9023-da8ee6353eb327
311288levETIRAcetam 250 MG Oral TabletPSN6d71e14f-8092-444c-afa1-2b79d69d81e63
311289levETIRAcetam 500 MG Oral TabletPSN6d71e14f-8092-444c-afa1-2b79d69d81e63
311290levETIRAcetam 750 MG Oral TabletPSN6d71e14f-8092-444c-afa1-2b79d69d81e63
311288levetiracetam 250 MG Oral TabletSCD6d71e14f-8092-444c-afa1-2b79d69d81e63
311289levetiracetam 500 MG Oral TabletSCD6d71e14f-8092-444c-afa1-2b79d69d81e63
311290levetiracetam 750 MG Oral TabletSCD6d71e14f-8092-444c-afa1-2b79d69d81e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-014-0513668001405500 TABLET in 1 BOTTLE (13668-014-05) 500 tablet2009-01-150000-00-00NoNoCurrent
13668-014-1213668001412120 TABLET in 1 BOTTLE (13668-014-12) 120 tablet2009-01-150000-00-00NoNoCurrent
13668-014-2513668001425250 TABLET in 1 BOTTLE (13668-014-25) 250 tablet2009-01-150000-00-00NoNoCurrent
13668-014-31136680014312500 TABLET in 1 BOTTLE (13668-014-31) 2500 tablet2009-01-150000-00-00NoNoCurrent
13668-014-601366800146060 TABLET in 1 BOTTLE (13668-014-60) 60 tablet2009-01-150000-00-00NoNoCurrent
13668-014-771366800147780 TABLET in 1 CARTON (13668-014-77) 80 tablet2009-01-150000-00-00NoNoCurrent