LEVETIRACETAM

Product NDC
61919-320
11-digit product format
619190320
Labeler code
61919
Product ID
61919-320_2b3329d0-adc3-4f6a-a471-048550297e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078154
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
250 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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
61919-320-302020-01-31C16284748780-19d75b9d0-d6de-f424-e053-dadaa90a57ceLEVETIRACETAM
61919-320-602020-01-31C16284748780-19d75b9d0-d6de-f424-e053-dadaa90a57ceLEVETIRACETAM
61919-320-722020-01-31C16284748780-19d75b9d0-d6de-f424-e053-dadaa90a57ceLEVETIRACETAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-320-30LEVETIRACETAM30 in 1 BOTTLETABLET303
61919-320-60LEVETIRACETAM60 in 1 BOTTLETABLET603
61919-320-72LEVETIRACETAM120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-320-60EA - Each61919-32055177263-5434-475c-b8f4-e9e92a19385012014-06-03
61919-320-72EA - Each61919-320253c40b1-084d-4bbc-a397-27db2b9ed23312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [DIRECT RX]3
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET [DIRECT RX]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET [DIRECT RX]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET [DIRECT RX]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET [DIRECT RX]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET [DIRECT RX]3
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET [DIRECT RX]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET [DIRECT RX]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-320LEVETIRACETAM TABLET [DIRECT RX]3Legacy NDC, 3 package rows20151106_f691fe85-a3dd-40b8-83ac-c1fa27907e6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNf691fe85-a3dd-40b8-83ac-c1fa27907e6a3
311288levetiracetam 250 MG Oral TabletSCDf691fe85-a3dd-40b8-83ac-c1fa27907e6a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-320-306191903203030 in 1 BOTTLEHistorical
61919-320-606191903206060 in 1 BOTTLEHistorical
61919-320-7261919032072120 in 1 BOTTLEHistorical