Home NDC 76420-219 Ropidex
Product NDC 76420-219
11-digit product format 764200219
Labeler code 76420
Product ID 76420-219_23b36bd4-0dbc-366a-e063-6294a90a1565
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexamethasone Sodium Phosphate, Ropivacaine Hydrochloride, Povidine Iodine
Dosage form KIT
Route EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; PERINEURAL; TOPICAL
Labeler Asclemed USA, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2019-06-10
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 Ropidex
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797730 Internal RxNorm lookup 1734483 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 55150-197-20 Ropidex 25 in 1 CARTON INJECTION, SOLUTION 5 mg in 1mL 4 55150-197-20 Ropidex 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 mL 5 mg in 1mL 4 76420-219-01 Ropidex 1 in 1 CARTON KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-219 ROPIDEX (DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20241008_2577c1ba-8aff-4098-ba11-a375e9ce3caa.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 Ropidex DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINE Asclemed USA, Inc. 2577c1ba-8aff-4098-ba11-a375e9ce3caa 2024-10-04 Warnings, Adverse reactions Exact identifier ndc (product): 76420-219
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 55150-197-20 55150019720 25 in 1 CARTON Historical 76420-219-01 76420021901 1 KIT in 1 CARTON (76420-219-01) * 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL 1 kit 2019-06-10 0000-00-00 No No Current