FDA.reportPublic FDA data

Levetiracetam

Product NDC
0121-4799
11-digit product format
001214799
Labeler code
0121
Product ID
0121-4799_f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVETIRACETAM
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA201157
Marketing category
ANDA
Marketing start
2015-06-04
Substance
LEVETIRACETAM
Active strength
500 mg/5mL
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/5mL

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
0121-4799-05Levetiracetam5 mL in 1 CUP, UNIT-DOSESOLUTION523
0121-4799-40Levetiracetam10 in 1 TRAYSOLUTION1023
0121-4799-40Levetiracetam4 in 1 CASESOLUTION423
0121-4799-50Levetiracetam5 in 1 CASESOLUTION523
0121-4799-50Levetiracetam10 in 1 TRAYSOLUTION1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4799-05ML - Milliliter0121-47999adef6d3-d410-4241-9707-82c6172699cb12015-10-02
0121-4799-40ML - Milliliter0121-4799ddeb4f82-9ea0-47c0-9435-2d83cf8d200212017-11-06
0121-4799-50ML - Milliliter0121-4799b276ccb7-9808-4b82-acbf-9f4182a95ab012020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVETIRACETAMACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
LEVETIRACETAMACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
MALTITOLINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4799LEVETIRACETAM SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]23Current NDC, Legacy NDC, 5 package rows20240507_9dca1330-52ca-47a4-a134-ec55c9d5786d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSN9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levetiracetam 100 MG/ML Oral SolutionSCD9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levetiracetam 100 MG per 1 ML Oral SolutionSY9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levetiracetam 1000 MG per 10 ML Oral SolutionSY9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levetiracetam 1500 MG per 15 ML Oral SolutionSY9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levetiracetam 500 MG per 5 ML Oral SolutionSY9dca1330-52ca-47a4-a134-ec55c9d5786d23
403884levETIRAcetam 100 MG in 1 mL Oral SolutionPSNf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 100 MG/ML Oral SolutionSCDf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 100 MG per 1 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 1000 MG per 10 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 1500 MG per 15 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8
403884levetiracetam 500 MG per 5 ML Oral SolutionSYf924d55d-d7ec-4448-b54e-3a7eaf5a1cab8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4799-05001214799055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-4799-40001214799404 TRAY in 1 CASE (0121-4799-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05) 4 tray2015-06-040000-00-00NoNoCurrent
0121-4799-50001214799505 TRAY in 1 CASE (0121-4799-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4799-05) 5 tray2020-05-280000-00-00NoNoCurrent