FDA.reportPublic FDA data

Levetiracetam

Product NDC
60505-3518
11-digit product format
605053518
Labeler code
60505
Product ID
60505-3518_2e47ee1c-2875-27e8-6069-a491f7ef3b6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA202958
Marketing category
ANDA
Marketing start
2015-02-25
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
Rxcui807832, 846378, 1605362

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
60505-3518-6Levetiracetam60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3518LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP.]19Current NDC, Legacy NDC, 1 package rows20241012_abc9fada-c5c2-4e07-fb8a-4d1518f7657e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605362levETIRAcetam 1000 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSNabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
160536224 HR levetiracetam 1000 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCDabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
1605362levetiracetam 1000 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSYabc9fada-c5c2-4e07-fb8a-4d1518f7657e20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-3518-66050535180660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-3518-6) 2015-02-250000-00-00NoNoCurrent