FDA.reportPublic FDA data

Levetiracetam

Product NDC
60432-831
11-digit product format
604320831
Labeler code
60432
Product ID
60432-831_19af8ef3-5c6c-4c80-8338-fd54e2fcb51b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levetiracetam
Dosage form
SOLUTION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA090028
Marketing category
ANDA
Marketing start
2010-03-18
Marketing end
0000-00-00
Substance
LEVETIRACETAM
Active strength
100 mg/mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
76e81f18-c6b9-f226-530a-a6296d5cd5f4Product name620251106
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
087c9486-f4a9-a565-c6fb-d6fa49f4572aProduct name620230317
525a8d4d-1988-fc3f-e292-27fd384de4f0Product name820230104
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
32b651f8-caa7-6882-11c7-54c4ad21796bProduct name820201216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ce453ca5-90cf-41ed-9de4-de519f70a0f2Product name220160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
66666eb8-1fa6-4a60-bae9-e564e73b4cd5Product name120150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477Product name120150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-831-162023-01-30C16284748780-1f386c64a-1912-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Levetiracetam Oral Solution safely and effectively. See full prescribing information for Levetiracetam Oral Solution. Levetiracetam Oral Solution Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60432-831-16Levetiracetam473 mL in 1 BOTTLE, PLASTICSOLUTION47314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-831-16ML - Milliliter60432-831144b7fc4-fd8e-48a3-868a-20bdc7a3f67a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
LevetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-831LEVETIRACETAM SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]14Legacy NDC, 1 package rows20201224_3edcaae5-81bb-4a18-8bfd-834835187b13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 100 MG/ML Oral SolutionSCD3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 100 MG per 1 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314
403884levetiracetam 500 MG per 5 ML Oral SolutionSY3edcaae5-81bb-4a18-8bfd-834835187b1314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-831-1660432083116473 mL in 1 BOTTLE, PLASTIC (60432-831-16) 473 ml2010-03-180000-00-00NoNoCurrent