Home NDC 80425-0349-1 Dyural 80 Kit
Product NDC 80425-0349
Requested package NDC 80425-0349-1
11-digit product format 804250349
Labeler code 80425
Product ID 80425-0349_2a9c2eb6-a6dd-f647-e063-6294a90a93fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol
Dosage form KIT
Route EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-07-31
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dyural 80 Kit
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 9 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 797730 Internal RxNorm lookup 1725078 Internal RxNorm lookup 1725082 Internal RxNorm lookup 1737566 Internal RxNorm lookup 1743855 Internal RxNorm lookup 1807631 Internal RxNorm lookup 1807637 Internal RxNorm lookup 1807638 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-4887-17 Dyural 80 Kit 10 mL in 1 VIAL, PLASTIC INJECTION 10 mL 1 mL in 1mL 2 0409-4888-02 Dyural 80 Kit 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 mL 9 mg in 1mL 2 70121-1574-1 Dyural 80 Kit 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 1 mL 80 mg in 1mL 2 70121-1574-1 Dyural 80 Kit 1 in 1 CARTON INJECTION, SUSPENSION 80 mg in 1mL 2 80425-0349-1 Dyural 80 Kit 1 in 1 CARTON KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0349 DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 5 package rows 20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dyural 80 Kit METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL Advanced Rx Pharmacy of Tennessee, LLC 01ca2f07-9c84-e418-e063-6294a90ac760 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 80425-0349-1 ndc (product): 80425-0349 ndc11 (package): 80425034901
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0349-1 80425034901 1 KIT in 1 CARTON (80425-0349-1) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) 1 kit 2023-07-31 No No Current