Levetiracetam

Product NDC
64725-1130
11-digit product format
647251130
Labeler code
64725
Product ID
64725-1130_bcac1969-90c5-4abe-a3af-94566ef8a85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-01
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
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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1130-1Levetiracetam30 in 1 CONTAINERTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1130LEVETIRACETAM TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141019_0081f751-e2e5-4d28-9053-306accab3561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN0081f751-e2e5-4d28-9053-306accab35612
311289levetiracetam 500 MG Oral TabletSCD0081f751-e2e5-4d28-9053-306accab35612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1130-16472511300130 in 1 CONTAINERHistorical