Home NDC 72516-024 Papaverine Hydrochloride
Product NDC 72516-024
11-digit product format 725160024
Labeler code 72516
Product ID 72516-024_2b4bd8c6-2b93-d435-e063-6394a90ae742
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Papaverine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Oryza Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2021-02-01
Substance PAPAVERINE HYDROCHLORIDE
Active strength 30 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72516-024 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72516-024 72516-024-25 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72516-024 72516-024-10 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Papaverine Hydrochloride
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72516-024-10 Papaverine Hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 4 72516-024-10 Papaverine Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 4 72516-024-25 Papaverine Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 4 72516-024-25 Papaverine Hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72516-024 PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [ORYZA PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 4 package rows 20250115_5ba6e650-a5b5-4381-a62a-b7a6df73e8e6.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 72516-024-10 72516002410 10 VIAL in 1 CARTON (72516-024-10) / 2 mL in 1 VIAL 10 vial 2021-02-01 0000-00-00 No No Current 72516-024-25 72516002425 25 VIAL in 1 CARTON (72516-024-25) / 2 mL in 1 VIAL 25 vial 2021-02-01 0000-00-00 No No Current