FDA.reportPublic FDA data

Levetiracetam

Product NDC
43547-221
11-digit product format
435470221
Labeler code
43547
Product ID
43547-221_da6c3e56-5044-4f0b-9f0e-7267e2fe89bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA078106
Marketing category
ANDA
Marketing start
2012-09-11
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
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
43547-221-15Levetiracetam120 in 1 BOTTLETABLET, FILM COATED12020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-221-15EA - Each43547-221815028b6-5ba6-4c94-bca5-66dca7c9e04812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
POLYETHYLENE GLYCOL 800INACTIVE INGREDIENTUH6KR4953DLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-221LEVETIRACETAM TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]20Current NDC, Legacy NDC, 1 package rows20240420_dd713e60-478c-43cd-b680-ff594a0b3864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387003levETIRAcetam 1000 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311288levETIRAcetam 250 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311289levETIRAcetam 500 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
311290levETIRAcetam 750 MG Oral TabletPSNdd713e60-478c-43cd-b680-ff594a0b386420
387003levetiracetam 1000 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311288levetiracetam 250 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311289levetiracetam 500 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311290levetiracetam 750 MG Oral TabletSCDdd713e60-478c-43cd-b680-ff594a0b386420
311288levETIRAcetam 250 MG Oral TabletPSN912f771a-2cd0-2625-e053-2995a90a22443
311288levetiracetam 250 MG Oral TabletSCD912f771a-2cd0-2625-e053-2995a90a22443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-221-1543547022115120 TABLET, FILM COATED in 1 BOTTLE (43547-221-15) 2012-09-110000-00-00NoNoCurrent