Levetiracetam

Product NDC
72205-094
11-digit product format
722050094
Labeler code
72205
Product ID
72205-094_600a1657-72c4-4ff5-aa6f-341ac75439c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214815
Marketing category
ANDA
Marketing start
2022-10-07
Substance
LEVETIRACETAM
Active strength
250 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
LEVETIRACETAM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311288, 311289, 311290, 387003

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-094-92Levetiracetam120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-094-92EA - Each72205-094e7fbe6c8-babd-42e4-9683-1e0cddf893bd12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-094LEVETIRACETAM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20250101_1c4450a1-6c05-4b45-a733-c19b4e861970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311288levETIRAcetam 250 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311289levETIRAcetam 500 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311290levETIRAcetam 750 MG Oral TabletPSNdfb7c640-623e-43d1-8ee8-479dccd53d0a7
387003levetiracetam 1000 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311288levetiracetam 250 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311289levetiracetam 500 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
311290levetiracetam 750 MG Oral TabletSCDdfb7c640-623e-43d1-8ee8-479dccd53d0a7
387003levETIRAcetam 1000 MG Oral TabletPSN1c4450a1-6c05-4b45-a733-c19b4e8619703
311288levETIRAcetam 250 MG Oral TabletPSN1c4450a1-6c05-4b45-a733-c19b4e8619703
311289levETIRAcetam 500 MG Oral TabletPSN1c4450a1-6c05-4b45-a733-c19b4e8619703
311290levETIRAcetam 750 MG Oral TabletPSN1c4450a1-6c05-4b45-a733-c19b4e8619703
387003levetiracetam 1000 MG Oral TabletSCD1c4450a1-6c05-4b45-a733-c19b4e8619703
311288levetiracetam 250 MG Oral TabletSCD1c4450a1-6c05-4b45-a733-c19b4e8619703
311289levetiracetam 500 MG Oral TabletSCD1c4450a1-6c05-4b45-a733-c19b4e8619703
311290levetiracetam 750 MG Oral TabletSCD1c4450a1-6c05-4b45-a733-c19b4e8619703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-094-9272205009492120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72205-094-92) 2022-10-140000-00-00NoNoCurrent