FDA.reportPublic FDA data

Levetiracetam

Product NDC
68180-117
11-digit product format
681800117
Labeler code
68180
Product ID
68180-117_8690e365-04d0-44ee-98ec-281e438ee0b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA091399
Marketing category
ANDA
Marketing start
2011-09-12
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
Rxcui807832, 846378

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68180-117-02Levetiracetam500 in 1 BOTTLETABLET, EXTENDED RELEASE50022
68180-117-07Levetiracetam60 in 1 BOTTLETABLET, EXTENDED RELEASE6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-117-07EA - Each68180-11799e62430-ad27-4b5a-8405-a028a0c98f9f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EALEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-117LEVETIRACETAM TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20250201_18648f51-a37c-41e1-b451-123bc0cf5446.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN18648f51-a37c-41e1-b451-123bc0cf544622
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN18648f51-a37c-41e1-b451-123bc0cf544622
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD18648f51-a37c-41e1-b451-123bc0cf544622
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD18648f51-a37c-41e1-b451-123bc0cf544622
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY18648f51-a37c-41e1-b451-123bc0cf544622
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY18648f51-a37c-41e1-b451-123bc0cf544622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-117-0268180011702500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-02) 2011-09-120000-00-00NoNoCurrent
68180-117-076818001170760 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-117-07) 2011-09-120000-00-00NoNoCurrent