FDA.reportPublic FDA data

LEVETIRACETAM

Product NDC
13668-300
11-digit product format
136680300
Labeler code
13668
Product ID
13668-300_724c2e0f-2d55-4a25-a514-125371becd21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091338
Marketing category
ANDA
Marketing start
2026-01-30
Substance
LEVETIRACETAM
Active strength
750 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
LEVETIRACETAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui807832, 846378

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
13668-300-05LEVETIRACETAM500 in 1 BOTTLETABLET, EXTENDED RELEASE50016
13668-300-12LEVETIRACETAM120 in 1 BOTTLETABLET, EXTENDED RELEASE12016
13668-300-25LEVETIRACETAM250 in 1 BOTTLETABLET, EXTENDED RELEASE25016
13668-300-60LEVETIRACETAM60 in 1 BOTTLETABLET, EXTENDED RELEASE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-300-60EA - Each13668-300a78b2290-6d62-4b08-ba0e-912ec4b9afad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BLEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN7cb669d7-d1aa-43b3-a322-0a2eaa13c65616
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN7cb669d7-d1aa-43b3-a322-0a2eaa13c65616
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD7cb669d7-d1aa-43b3-a322-0a2eaa13c65616
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD7cb669d7-d1aa-43b3-a322-0a2eaa13c65616
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY7cb669d7-d1aa-43b3-a322-0a2eaa13c65616
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY7cb669d7-d1aa-43b3-a322-0a2eaa13c65616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-300-0513668030005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-05) 2026-01-30NoNoCurrent
13668-300-1213668030012120 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-12) 2026-01-30NoNoCurrent
13668-300-2513668030025250 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-25) 2026-01-30NoNoCurrent
13668-300-601366803006060 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-300-60) 2026-01-30NoNoCurrent