FDA.reportPublic FDA data

NDC 80425-0348-01 - Dyural 40 Kit

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
80425-0348
Requested NDC
80425-0348-01
Package NDCs from labels
80425-0348-1, 80425-0348-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dyural 40 Kit - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4887-17Dyural 40 Kit10 mL in 1 VIAL, PLASTICINJECTION10 mL1 mL in 1mL2
0409-4888-02Dyural 40 Kit10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION10 mL9 mg in 1mL2
70121-1573-5Dyural 40 Kit25 in 1 CARTONINJECTION, SUSPENSION40 mg in 1mL2
70121-1573-5Dyural 40 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL40 mg in 1mL2
80425-0348-1Dyural 40 Kit1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0348DYURAL 40 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 5 package rows20250102_01ca16de-ab2e-4e19-e063-6394a90a0510.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0348-1EA - Each80425-0348ba076026-5416-442a-a3ad-ed31cc18be7012023-09-05

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 106 of 238 · 4,758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium Chloride in Lactated Ringers and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporation05f326e6-10e4-4ceb-8a23-f53c592f00b82025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE AND DEXTROSE MONOHYDRATEBaxter Healthcare Corporation6acc9f96-7088-45a7-b48f-1a861e3467ab2025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDEBaxter Healthcare Companydad7735c-709b-40ea-ab7a-15577e24a9662025-10-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
GrowDefender Antibacterial FoamANTIBACTERIAL FOAMGrow Defender LLC423af3d9-6413-c097-e063-6294a90ae1a92025-10-28WarningsExact identifier
application number: M003
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsExact identifier
application number: M003
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsExact identifier
application number: M003
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionse8209047-c1e6-4081-a6d3-c603d9ee4f142025-10-27Warnings, Adverse reactionsExact identifier
unii: 43502P7F0P
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc496ccd9e-d1c3-4b5a-93b6-0c457faa15892025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1012404
unii: 7TQO7W3VT8
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421cfe98-7a20-c37c-e063-6294a90ad4b52025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce33e-4639-e881-e063-6394a90a57ef2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d994c-bf62-2f40-e063-6294a90a64882025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d2fd-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7bd9-c892-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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