FDA.reportPublic FDA data

NDC 66689-028-01 - 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
66689-028
Requested NDC
66689-028-01
Package NDCs from labels
66689-028-01, 66689-028-50
Manufacturer
VistaPharm, LLC
Effective date
2022-11-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levetiracetam - VistaPharm, LLCVistaPharm, LLC2022-11-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-028-01ML - Milliliter66689-02854873b8a-90c5-453e-bc14-4ce23bc212d212012-07-24
66689-028-50ML - Milliliter66689-028a8c7728e-1bbd-4637-9c28-3865ce4ee85e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevetiracetamACTIVE INGREDIENT44YRR34555LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
LevetiracetamACTIVE MOIETY44YRR34555LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9LEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
glycyrrhizin, ammoniatedINACTIVE INGREDIENT3VRD35U26CLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
maltitolINACTIVE INGREDIENTD65DG142WKLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2
waterINACTIVE INGREDIENT059QF0KO0RLEVETIRACETAM SOLUTION [VISTAPHARM, INC]2

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 34 of 35 · 699 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
LevetiracetamLEVETIRACETAMFresenius Kabi USA, LLCcc41696c-9cf0-4410-bacc-09132ee805ce2022-01-24Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Incbe8ec971-c4f1-3e53-77e1-8337d9d506eb2021-12-31Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Inc0a9234b7-46b1-8e6c-a992-90f86cfb6e002021-12-31Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: B22547B95K
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: B22547B95K
InterSolPLATELET ADDITIVE 3Fenwal, Inc.e4f06c0b-7cb1-49c9-97a4-2cfc212984952021-11-16Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Solucion InterSolSOLUCION ADITIVA PARA PLAQUETAS 3Fenwal, Inc.d5eaf5f4-67d3-4475-af9a-f5b0f882f5d12021-10-04Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
InterSolPLATELET ADDITIVE 3Fenwal, Inc.a00c4a93-cde2-4753-81f7-0d6fee9fb6902020-10-20Warnings, Adverse reactionsExact identifier
unii: B22547B95K
GUNA FLAM RELIEFACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -Guna spaaf5a9c74-e1c7-6574-e053-2995a90a3d102020-09-15WarningsExact identifier
unii: 2968PHW8QP
LevetiracetamLEVETIRACETAMPrinston Pharmaceutical Inc.d818ef84-9b3e-434b-92d9-910cfa8af7da2020-08-01Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: B22547B95K
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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