Levetiracetam

Product NDC
16714-358
11-digit product format
167140358
Labeler code
16714
Product ID
16714-358_07969bad-3551-432a-b762-06625a68342a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA079063
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
16714-358-01Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-358-01ML - Milliliter16714-358909a6b73-cadc-4eb2-bbf8-edf4e6abd30c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-358LEVETIRACETAM SOLUTION [NORTHSTAR RX LLC]21Current NDC, Legacy NDC, 1 package rows20241030_483a42b9-c8f3-4f8b-98be-fcac5ab23c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21
403884levetiracetam 100 MG/ML Oral SolutionSCD483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21
403884levetiracetam 100 MG per 1 ML Oral SolutionSY483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21
403884levetiracetam 500 MG per 5 ML Oral SolutionSY483a42b9-c8f3-4f8b-98be-fcac5ab23c7c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-358-0116714035801473 mL in 1 BOTTLE, PLASTIC (16714-358-01) 473 ml2009-01-150000-00-00NoNoCurrent