FDA.reportPublic FDA data

Levetiracetam

Product NDC
13668-017
11-digit product format
136680017
Labeler code
13668
Product ID
13668-017_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
1000 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
LEVETIRACETAM1000 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
13668-017-05Levetiracetam500 in 1 BOTTLETABLET50027
13668-017-12Levetiracetam120 in 1 BOTTLETABLET12027
13668-017-25Levetiracetam250 in 1 BOTTLETABLET25027
13668-017-60Levetiracetam60 in 1 BOTTLETABLET6027
13668-017-65Levetiracetam650 in 1 BOTTLETABLET65027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-017-05EA - Each13668-017c7d2339a-63c9-4c3c-ba02-aa1a1653ed9512012-07-24
13668-017-12EA - Each13668-017226b9006-d256-4c2a-8285-e71e9bc09fb612012-07-24
13668-017-25EA - Each13668-0170d51685e-d38c-46a7-884d-2dabf9e1841d12012-07-24
13668-017-60EA - Each13668-017698be2f4-862c-49bc-9887-5cd6a784220412012-07-24
13668-017-61EA - Each13668-0179da3ce9b-3197-4ef7-a25e-b5e802ab63ea12012-07-24

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 [PHYSICIANS TOTAL CARE, INC.]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET [PHYSICIANS TOTAL CARE, INC.]7
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-017LEVETIRACETAM 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
387003levETIRAcetam 1000 MG Oral TabletPSN98bae5bb-729b-4a36-b429-5ee25aa804117
311289levETIRAcetam 500 MG Oral TabletPSN98bae5bb-729b-4a36-b429-5ee25aa804117
311290levETIRAcetam 750 MG Oral TabletPSN98bae5bb-729b-4a36-b429-5ee25aa804117
387003levetiracetam 1000 MG Oral TabletSCD98bae5bb-729b-4a36-b429-5ee25aa804117
311289levetiracetam 500 MG Oral TabletSCD98bae5bb-729b-4a36-b429-5ee25aa804117
311290levetiracetam 750 MG Oral TabletSCD98bae5bb-729b-4a36-b429-5ee25aa804117
387003levETIRAcetam 1000 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311288levETIRAcetam 250 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311289levETIRAcetam 500 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311290levETIRAcetam 750 MG Oral TabletPSN76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
387003levetiracetam 1000 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311288levetiracetam 250 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311289levetiracetam 500 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1
311290levetiracetam 750 MG Oral TabletSCD76c7e13d-37a0-4131-a1f1-fd5af0f60d3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-017-0513668001705500 TABLET in 1 BOTTLE (13668-017-05) 500 tablet2009-01-150000-00-00NoNoCurrent
13668-017-1213668001712120 TABLET in 1 BOTTLE (13668-017-12) 120 tablet2009-01-150000-00-00NoNoCurrent
13668-017-2513668001725250 TABLET in 1 BOTTLE (13668-017-25) 250 tablet2009-01-150000-00-00NoNoCurrent
13668-017-601366800176060 TABLET in 1 BOTTLE (13668-017-60) 60 tablet2009-01-150000-00-00NoNoCurrent
13668-017-611366800176150 TABLET in 1 CARTON (13668-017-61) 50 tablet2009-01-150000-00-00NoNoCurrent
13668-017-6513668001765650 TABLET in 1 BOTTLE (13668-017-65) 650 tablet2009-01-150000-00-00NoNoCurrent