FDA.reportPublic FDA data

NDC 0517-4002-01 - Papaverine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0517-4002
Requested NDC
0517-4002-01
Package NDCs from labels
0517-4002-01, 0517-4002-25
Manufacturer
American Regent, Inc.
Effective date
2026-07-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PAPAVERINE HYDROCHLORIDE INJECTION, USPAmerican Regent, Inc.2026-07-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-4002-01Papaverine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION28
0517-4002-25Papaverine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-4002PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Current NDC, Legacy NDC, 2 package rows20231118_9e5e2ce4-7a57-4c61-a826-64c8d11d038e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-4002-01ML - Milliliter0517-400289538ca6-e4d2-4acd-a678-54e176ff551812025-07-08
0517-4002-25ML - Milliliter0517-4002ba2a66a9-8fd7-4126-9d42-1556e513141712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAPAVERINE HYDROCHLORIDEACTIVE INGREDIENT23473EC6BQPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
PAPAVERINEACTIVE MOIETYDAA13NKG2QPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1

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 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Papaverine HydrochloridePAPAVERINE HYDROCHLORIDEAmerican Regent, Inc.9e5e2ce4-7a57-4c61-a826-64c8d11d038e2026-07-27Adverse reactionsExact identifier
ndc (package): 0517-4002-25
ndc (package): 0517-4002-01
ndc (product): 0517-4002
ndc11 (package): 00517400201
rxcui: 1789947
spl id: 402161da-fe45-4b0f-a5ca-a230593cc434
spl set id: 9e5e2ce4-7a57-4c61-a826-64c8d11d038e
unii: 23473EC6BQ
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.