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 84 of 239 · 4,780 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALGREENS BURNLIDOCAINE HYDROCHLORIDEWALGREENSb61e6d73-4f41-ef50-e053-2a95a90a0fc62025-12-29WarningsExact identifier
unii: V13007Z41A
AntisepticBENZETHONIUM CHLORIDEMPM Medical, LLC3f660269-f83d-4f71-9a70-e2ddb2c57ec62025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizing SpryHAND SANITIZER SPRAYSnugZ/USA, LLC9391bc26-57e6-daec-e053-2995a90a1eb62025-12-29WarningsExact identifier
application number: M003
SnugZ Beaded Hand Sanitizer GelBEADED HAND SANITIZER GELSnugZ/USA, LLC6deb1142-dfba-a72b-e053-2991aa0aba432025-12-29WarningsExact identifier
application number: M003
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
application number: M003
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
application number: M003
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
application number: M003
unii: ND2M416302
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
application number: M003
Dark 30-Pack Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.46e0c74f-30d6-6c24-e063-6394a90ad4872025-12-26WarningsExact identifier
unii: ND2M416302
Triple Allergy DefenseALLIUM CEPA, AMBROSIA ARTEMISIIFOLIA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, LEMNA MINOR, LUFFA OPERCULATA, NATRUM MURIATICUM, POLYPORUS PINICOLA, SABADILLANenningers Naturals, LLCe1459ef4-6980-4b2b-94c1-6c896a9cb6bd2025-12-25WarningsExact identifier
unii: 451W47IQ8X
Dr. Nenninger Cold and Sinus SolutionALLIUM CEPA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI IODATUM, NATRUM MURIATICUM, PULSATILLANenningers Naturals, LLC1e26b25c-5d93-4f69-aa9e-a187abd6d0352025-12-25WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
unii: 451W47IQ8X
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol Lil Drug Store ProductsISOPROPYL ALCOHOLLil' Drug Store Products, Incb55238e0-840a-449b-95be-4b372034c1e32025-12-23WarningsExact identifier
unii: ND2M416302
ActivMendARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, RHUS TOXICODENDRON, RUTA GRAVEOLENS, NATRUM MURATICUMCearna, Inc.baefc5d4-a7e4-4ba2-e053-2995a90a4b862025-12-23WarningsExact identifier
unii: 451W47IQ8X
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
unii: V13007Z41A
HumiraADALIMUMABCordavis Limited4977567e-3525-44ac-9ff5-f1e74b0539502025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544
HumiraADALIMUMABAbbVie Inc.608d4f0d-b19f-46d3-749a-7159aa5f933d2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 797544

Reported adverse events (FAERS/openFDA)#

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