Home NDC 0517-4002 Papaverine Hydrochloride
Product NDC 0517-4002
11-digit product format 005174002
Labeler code 0517
Product ID 0517-4002_0a4f7219-b60d-46ff-9c63-e21271569771
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Papaverine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1995-09-01
Substance PAPAVERINE HYDROCHLORIDE
Active strength 30 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Papaverine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PAPAVERINE HYDROCHLORIDE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 23473EC6BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1789947 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 0517-4002-01 Papaverine Hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 8 0517-4002-25 Papaverine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PAPAVERINE HYDROCHLORIDE ACTIVE INGREDIENT 23473EC6BQ PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 PAPAVERINE ACTIVE MOIETY DAA13NKG2Q PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 CHLOROBUTANOL INACTIVE INGREDIENT HM4YQM8WRC PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-4002 PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231118_9e5e2ce4-7a57-4c61-a826-64c8d11d038e.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.
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 0517-4002-01 00517400201 2 mL in 1 VIAL 2 ml Historical 0517-4002-25 00517400225 25 VIAL in 1 CARTON (0517-4002-25) / 2 mL in 1 VIAL (0517-4002-01) 25 vial 1995-09-01 0000-00-00 No No Current