FDA.reportPublic FDA data

NDC 85957-037-01 - Levetiracetam

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
85957-037
Requested NDC
85957-037-01
Package NDCs from labels
85957-037-01, 85957-037-02
Manufacturer
Aryeh Pharma corp
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam - Aryeh Pharma corpAryeh Pharma corp2026-04-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85957-037-01Levetiracetam5 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE52
85957-037-02Levetiracetam10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE102

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.a05bbfa4-c34f-4134-8207-db79e4c704452026-06-12Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.23073db5-3fc4-4051-a22d-e49a63e426472026-06-10Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMPD-Rx Pharmaceuticals, Inc.c4b2da6a-ed50-4a54-90bd-32f76b1787362026-06-08Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC53843871-23e3-974e-e063-6394a90a80422026-06-05Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCardinal Health 107, LLCf924d55d-d7ec-4448-b54e-3a7eaf5a1cab2026-06-04Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMREMEDYREPACK INC.c12d8af3-39a8-4690-8d47-43dec70b75792026-06-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMInjecta Medcial LLC52fa0eec-3dd9-59ca-e063-6394a90a97912026-05-29Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.419b3dba-ae21-4268-ac8b-342aaa6095542026-05-18Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMBryant Ranch Prepackc4a3018a-3cd8-4e07-a840-099ceae01c912026-05-15Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC51b66893-f7d6-8f9d-e063-6294a90a8e9b2026-05-13Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMLupin Pharmaceuticals, Inc.df661166-325d-4071-9bc1-f7bf992996d22026-05-11Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMASCLEMED USA INC.a3c57d82-511c-4c7d-84ff-f791f931f5762026-05-07Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC513f422f-1637-5f41-e063-6294a90ab5482026-05-07Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMBryant Ranch Prepack65a76fcb-31a8-4c5a-9ffe-5393fc4dac342026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 647121
unii: 44YRR34555
levetiracetamLEVETIRACETAMBryant Ranch Prepackba18ead0-69d7-453a-badc-cd6ad376d18e2026-05-06Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMCoupler LLC5037a86a-21f2-d793-e063-6394a90a2cb52026-04-24Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAM IN SODIUM CHLORIDESomerset Therapeutics, LLC2b37c579-ebe7-4ce1-8a34-03e974a774392026-04-20Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LEVETIRACETAMLEVETIRACETAMBionpharma Inc.1d75b15e-881c-a00f-e063-6394a90a41382026-04-17Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAMAryeh Pharma corp4f8ffd81-f814-f288-e063-6394a90a5eb52026-04-16Warnings, Adverse reactionsExact identifier
application number: ANDA091485
ndc (package): 85957-037-01
ndc (package): 85957-037-02
ndc (product): 85957-037
ndc11 (package): 85957003701
rxcui: 647121
spl id: 4f91fcd5-7a0c-9619-e063-6294a90ab937
spl set id: 4f8ffd81-f814-f288-e063-6394a90a5eb5
unii: 44YRR34555
LevetiracetamLEVETIRACETAMSafecor Health LLCe72a7410-13fd-40e4-befb-052d0455e0382026-04-09Warnings, Adverse reactionsExact identifier
unii: 44YRR34555

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.