Levetiracetam

Product NDC
55111-182
11-digit product format
551110182
Labeler code
55111
Product ID
55111-182_2de4ebba-b125-4355-35f5-69b92e56634b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076920
Marketing category
ANDA
Marketing start
2009-01-15
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
Rxcui311288, 311289, 311290

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
55111-182-01Levetiracetam100 in 1 BOTTLETABLET1007
55111-182-04Levetiracetam120 in 1 BOTTLETABLET1207
55111-182-05Levetiracetam500 in 1 BOTTLETABLET5007
55111-182-30Levetiracetam30 in 1 BOTTLETABLET307
55111-182-79Levetiracetam1 in 1 CARTONTABLET17
55111-182-79Levetiracetam10 in 1 BLISTER PACKTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-182-04EA - Each55111-1822e50121a-c7a1-4605-914b-c4bab3533b3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
levetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
levetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
hypromellose 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
povidoneINACTIVE INGREDIENTFZ989GH94ELEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
starch, cornINACTIVE INGREDIENTO8232NY3SJLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
talcINACTIVE INGREDIENT7SEV7J4R1ULEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-182LEVETIRACETAM TABLET [DR. REDDY'S LABORATORIES LIMITED]7Current NDC, Legacy NDC, 6 package rows20181207_ee03507b-cb35-4fe9-ae7b-85ea89f876f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311288levETIRAcetam 250 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311289levETIRAcetam 500 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311290levETIRAcetam 750 MG Oral TabletPSNee03507b-cb35-4fe9-ae7b-85ea89f876f07
311288levetiracetam 250 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07
311289levetiracetam 500 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07
311290levetiracetam 750 MG Oral TabletSCDee03507b-cb35-4fe9-ae7b-85ea89f876f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-182-0155111018201100 TABLET in 1 BOTTLE (55111-182-01) 100 tablet2009-01-150000-00-00NoNoCurrent
55111-182-0455111018204120 TABLET in 1 BOTTLE (55111-182-04) 120 tablet2009-01-150000-00-00NoNoCurrent
55111-182-0555111018205500 TABLET in 1 BOTTLE (55111-182-05) 500 tablet2009-01-150000-00-00NoNoCurrent
55111-182-305511101823030 TABLET in 1 BOTTLE (55111-182-30) 30 tablet2009-01-150000-00-00NoNoCurrent
55111-182-79551110182791 BLISTER PACK in 1 CARTON (55111-182-79) / 10 TABLET in 1 BLISTER PACK1 blister pack2009-01-150000-00-00NoNoCurrent