LEVETIRACETAM

Product NDC
61919-685
11-digit product format
619190685
Labeler code
61919
Product ID
61919-685_e9ac5d16-2a14-e628-e053-2a95a90aee68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078154
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
500 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-685-302025-01-30C16284748780-12cef2736-81cc-d83d-e063-dadaa90ab31fLEVETIRACETAM
61919-685-602025-01-30C16284748780-12cef2736-81cc-d83d-e063-dadaa90ab31fLEVETIRACETAM
61919-685-722025-01-30C16284748780-12cef2736-81cc-d83d-e063-dadaa90ab31fLEVETIRACETAM
61919-685-902025-01-30C16284748780-12cef2736-81cc-d83d-e063-dadaa90ab31fLEVETIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-685-30LEVETIRACETAM30 in 1 BOTTLETABLET, FILM COATED3011
61919-685-60LEVETIRACETAM60 in 1 BOTTLETABLET, FILM COATED6011
61919-685-72LEVETIRACETAM120 in 1 BOTTLETABLET, FILM COATED12011
61919-685-90LEVETIRACETAM90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-685-30EA - Each61919-68542749048-2397-4111-ba97-aff1554dcda912023-08-08
61919-685-60EA - Each61919-68557d732fa-c1ed-4430-85bb-692ce927fc0312015-04-03
61919-685-72EA - Each61919-6856349c5ae-2dbd-4eeb-9010-695f0ed306af12019-11-12
61919-685-90EA - Each61919-685e0edb23b-5981-4d0b-9f37-342f6ec62c4c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-685LEVETIRACETAM TABLET, FILM COATED [DIRECT RX]11Legacy NDC, 4 package rows20230707_96bc35a8-eed6-4f0c-b149-1e4c533aa90e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN96bc35a8-eed6-4f0c-b149-1e4c533aa90e11
311289levetiracetam 500 MG Oral TabletSCD96bc35a8-eed6-4f0c-b149-1e4c533aa90e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-685-306191906853030 in 1 BOTTLEHistorical
61919-685-606191906856060 TABLET, FILM COATED in 1 BOTTLE (61919-685-60) 2022-09-270000-00-00NoNoCurrent
61919-685-7261919068572120 TABLET, FILM COATED in 1 BOTTLE (61919-685-72) 2014-01-010000-00-00NoNoCurrent
61919-685-906191906859090 BOTTLE in 1 BOTTLE (61919-685-90) > 60 TABLET, FILM COATED in 1 BOTTLE (61919-685-60) 90 bottle2015-03-050000-00-00NoNoCurrent