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 37 of 243 · 4,850 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
caring mill Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.80997bb6-b878-45d4-a6e9-4ae37442d67e2026-05-06WarningsExact identifier
rxcui: 797544
unii: ND2M416302
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
application number: M003
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
application number: M003
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
unii: G2M7P15E5P
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsExact identifier
unii: V13007Z41A
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
unii: V13007Z41A
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsExact identifier
application number: M003
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
unii: V13007Z41A
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsExact identifier
application number: M003
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
unii: V13007Z41A
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
unii: G2M7P15E5P
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsExact identifier
application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUMALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52084e0a-ffe2-83f4-e063-6294a90a305e2026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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