FDA.reportPublic FDA data

Levetiracetam

Product NDC
63187-360
11-digit product format
631870360
Labeler code
63187
Product ID
63187-360_e47bfa3c-961e-45d8-a06a-d2d2a91fe115
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078154
Marketing category
ANDA
Marketing start
2009-01-01
Substance
LEVETIRACETAM
Active strength
500 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
LEVETIRACETAM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui311289

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
63187-360-30Levetiracetam30 in 1 BOTTLETABLET, FILM COATED304
63187-360-60Levetiracetam60 in 1 BOTTLETABLET, FILM COATED604
63187-360-90Levetiracetam90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-360-30EA - Each63187-3602eccc40a-ede3-4796-b3df-7f9130c01dbd12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-360LEVETIRACETAM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20240412_6bdbc193-d86b-4bd5-8e88-4ea964d2cdde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311289levETIRAcetam 500 MG Oral TabletPSN6bdbc193-d86b-4bd5-8e88-4ea964d2cdde4
311289levetiracetam 500 MG Oral TabletSCD6bdbc193-d86b-4bd5-8e88-4ea964d2cdde4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-360-306318703603030 TABLET, FILM COATED in 1 BOTTLE (63187-360-30) 2016-08-010000-00-00NoNoCurrent
63187-360-606318703606060 TABLET, FILM COATED in 1 BOTTLE (63187-360-60) 2016-08-010000-00-00NoNoCurrent
63187-360-906318703609090 TABLET, FILM COATED in 1 BOTTLE (63187-360-90) 2016-08-010000-00-00NoNoCurrent