Levetiracetam

Product NDC
0472-0235
11-digit product format
004720235
Labeler code
0472
Product ID
0472-0235_b64ea04d-69cd-4d88-885a-4210492d881c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA078976
Marketing category
ANDA
Marketing start
2009-01-15
Substance
LEVETIRACETAM
Active strength
100 mg/mL
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
LEVETIRACETAM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii44YRR34555
Rxcui403884

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
0472-0235-16Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47322

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0235-16ML - Milliliter0472-02354035a5af-b014-445f-8d2b-29b4d6cc9a4d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
GRAPEINACTIVE INGREDIENT6X543N684KLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [ACTAVIS MID ATLANTIC LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0235LEVETIRACETAM SOLUTION [ACTAVIS PHARMA, INC.]22Current NDC, Legacy NDC, 1 package rows20240625_5cb4a1db-f32d-44af-8985-0a94ca506468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN5cb4a1db-f32d-44af-8985-0a94ca50646822
403884levetiracetam 100 MG/ML Oral SolutionSCD5cb4a1db-f32d-44af-8985-0a94ca50646822
403884levetiracetam 100 MG per 1 ML Oral SolutionSY5cb4a1db-f32d-44af-8985-0a94ca50646822
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY5cb4a1db-f32d-44af-8985-0a94ca50646822
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY5cb4a1db-f32d-44af-8985-0a94ca50646822
403884levetiracetam 500 MG per 5 ML Oral SolutionSY5cb4a1db-f32d-44af-8985-0a94ca50646822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0235-1600472023516473 mL in 1 BOTTLE, PLASTIC (0472-0235-16) 473 ml2009-01-150000-00-00NoNoCurrent