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 86 of 239 · 4,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hair and Nail TonicAVENA, DNA, ELAEIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS, HEPAR SUIS, KALI SULPH, NAT MUR, NICOTINAMIDUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, THUJA OCC, THYROIDINUM, URTICA UR.Eight and Company L.L.C35bda785-b3a7-4928-aaea-27bf9fb6abb52025-12-18WarningsExact identifier
unii: 451W47IQ8X
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 1Q73Q2JULR
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 1Q73Q2JULR
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution38560997-cfe4-2f9b-e063-6394a90a834b2025-12-18Warnings, Adverse reactionsExact identifier
rxcui: 1737761
unii: V13007Z41A
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.afeccd10-c7e5-6193-e053-2995a90a9a5a2025-12-18WarningsExact identifier
application number: M003
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.ae4311f8-fc40-38a7-e053-2a95a90ae8292025-12-18WarningsExact identifier
application number: M003
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
application number: NDA018801
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2c33e5-290e-2f89-e063-6394a90aee692025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution42c973e2-307b-924c-e063-6394a90a737a2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724884
unii: 7TQO7W3VT8
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42caf92e-6fa9-5bd7-e063-6294a90a39042025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution42d9e4cf-ca73-ec6d-e063-6394a90ae9372025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEProPharma Distribution3f2bdb1f-f1c0-370d-e063-6294a90a5c502025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEProPharma Distribution43048b6b-3c83-eef4-e063-6294a90a34cb2025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEProPharma Distribution3f7ab295-6429-4760-e063-6294a90a781f2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA070583
rxcui: 1012396
unii: 7TQO7W3VT8
AplicarePOVIDONE-IODINEAplicare Products LLC0a48b8ef-f2d6-ed50-e063-6394a90a8ebe2025-12-18WarningsExact identifier
unii: 85H0HZU99M
AplicarePOVIDONE IODINEAplicare Products LLC0b3e4f14-e9e6-2f2e-e063-6394a90ab2e12025-12-18WarningsExact identifier
rxcui: 797730
unii: 85H0HZU99M
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC1ad9237e-80ee-4769-ba53-9bc1bb6672492025-12-18WarningsExact identifier
unii: 85H0HZU99M
lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC4643042c-ec95-3bad-e063-6294a90a82502025-12-18Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
AlcoholALCOHOLDynarex Corporation88c5dcbe-185f-4966-b98b-25d50299e8df2025-12-18WarningsExact identifier
application number: M003
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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