Home NDC 76420-810 Mardex 25 Kit
Product NDC 76420-810
11-digit product format 764200810
Labeler code 76420
Product ID 76420-810_47db0a49-753e-2eb3-e063-6294a90ab279
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride, Povidine Iodine
Dosage form KIT
Route EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler Asclemed USA, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-08-21
NDC exclude flag No
Listing certified through 2027-12-31
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 Mardex 25 Kit
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 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 1812079 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 76420-810-01 Mardex 25 Kit 1 in 1 CARTON KIT 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bupivacaine Hydrochloride ACTIVE INGREDIENT 7TQO7W3VT8 MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Dexamethasone Sodium Phosphate ACTIVE INGREDIENT AI9376Y64P MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Isopropyl Alcohol ACTIVE INGREDIENT ND2M416302 MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 POVIDONE-IODINE ACTIVE INGREDIENT 85H0HZU99M MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Bupivacaine ACTIVE MOIETY Y8335394RO MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Dexamethasone ACTIVE MOIETY 7S5I7G3JQL MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Iodine ACTIVE MOIETY 9679TC07X4 MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Isopropyl Alcohol ACTIVE MOIETY ND2M416302 MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Nonoxynol-9 INACTIVE INGREDIENT 48Q180SH9T MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-810 MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20241008_94472ddb-ae1d-4a11-a673-81254d562e6b.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 Mardex 25 Kit DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE Asclemed USA, Inc. 94472ddb-ae1d-4a11-a673-81254d562e6b 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 76420-810
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76420-810-01 76420081001 1 KIT in 1 CARTON (76420-810-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL 1 kit 2014-08-21 0000-00-00 No No Current