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 31 of 243 · 4,850 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHERK WATERMELON HAND SANITIZER WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd567dbd8c-3af6-34b4-e063-6394a90a0e232026-06-01WarningsExact identifier
application number: M003
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1724880
rxcui: 1724884
rxcui: 1012384
rxcui: 1012404
rxcui: 1672919
rxcui: 1724787
rxcui: 1867596
rxcui: 1725078
rxcui: 1012377
rxcui: 1725082
rxcui: 1012396
rxcui: 1672917
rxcui: 1867594
rxcui: 1724786
unii: 30Q7KI53AK
unii: 7TQO7W3VT8
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
unii: V13007Z41A
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.52db71d5-42fc-c3b6-e063-6394a90aea152026-05-28WarningsExact identifier
application number: M003
LidotholLIDOCAINE HCL, MENTHOLASCLEMED USA INC.4e2fad18-13f1-4e61-86db-d721029287172026-05-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Fanjian Medical Product Co.,Ltdf44aa5a9-45e2-b890-e053-2a95a90a421b2026-05-28WarningsExact identifier
unii: V13007Z41A
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
leuprolide acetateLEUPROLIDE ACETATEAmneal Pharmaceuticals LLC4838c674-044e-46b2-81e7-c691b99d8fa52026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 797544
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
unii: V13007Z41A
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
unii: V13007Z41A
MyMedic Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52b3ffec-8fe7-be9b-e063-6294a90a06922026-05-26WarningsExact identifier
application number: M003
MyMedic Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd52b5653e-289c-d99e-e063-6294a90aa6472026-05-26WarningsExact identifier
application number: M003
unii: ND2M416302
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
unii: V13007Z41A
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
unii: V13007Z41A
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Smart Care Hand Sanitizer 4pk with Glitter Silicone Case - Watermelon Splash, Mango Papaya, Pineapple Sunrise, Coconut WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.529f25f9-92eb-b7df-e063-6294a90a8dbc2026-05-25WarningsExact identifier
application number: M003
Elf Hand Sanitizer Gift Set Maple Syrup Drizzle, Peppermint Sugar Rush, Creamy Vanilla SwirlALCOHOLScent Theory Products LLC52aa188f-32b9-684a-e063-6294a90a8d4a2026-05-25WarningsExact identifier
application number: M003
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Pharmaceuticals USA Inc.35634415-000f-47db-9bd7-9e16eef3f02e2026-05-25Warnings, Adverse reactionsExact identifier
rxcui: 797544

Reported adverse events (FAERS/openFDA)#

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