FDA.reportPublic FDA data

Levetiracetam

Product NDC
69367-333
11-digit product format
693670333
Labeler code
69367
Product ID
69367-333_18d684d2-22a4-497a-ab10-f35ef53408ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA205130
Marketing category
ANDA
Marketing start
2021-09-30
Substance
LEVETIRACETAM
Active strength
750 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
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVETIRACETAM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui807832, 846378

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
69367-333-60Levetiracetam ER60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-333LEVETIRACETAM ER (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20240612_c508a392-0603-477d-8a45-3ec550371111.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSNc508a392-0603-477d-8a45-3ec5503711113
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSNc508a392-0603-477d-8a45-3ec5503711113
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCDc508a392-0603-477d-8a45-3ec5503711113
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCDc508a392-0603-477d-8a45-3ec5503711113
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSYc508a392-0603-477d-8a45-3ec5503711113
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSYc508a392-0603-477d-8a45-3ec5503711113
807832levETIRAcetam 500 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levETIRAcetam 750 MG 24HR Extended Release Oral TabletPSN57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
80783224 HR levetiracetam 500 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
84637824 HR levetiracetam 750 MG Extended Release Oral TabletSCD57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
807832levetiracetam 500 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52
846378levetiracetam 750 MG 24 HR Extended Release Oral TabletSY57b9dccb-6ee6-4e89-ab26-4c478e2df2b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-333-606936703336060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-333-60) 2021-09-300000-00-00NoNoCurrent