Papaverine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Papaverine Hydrochloride
Generic name: PAPAVERINE HYDROCHLORIDE
Manufacturer: American Regent, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 9e5e2ce4-7a57-4c61-a826-64c8d11d038e
SPL ID: 402161da-fe45-4b0f-a5ca-a230593cc434
Version: 9
Effective date: 2026-07-27
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:36:05

Harmonized routes table
Harmonized routes
INTRAVENOUS

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Papaverine Hydrochloride	openfda.brand_name
generic name		PAPAVERINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		American Regent, Inc.	openfda.manufacturer_name
ndc	package	0517-4002-25	openfda.package_ndc
ndc	package	0517-4002-01	openfda.package_ndc
ndc	product	0517-4002	openfda.product_ndc
ndc11	package	00517400201	derived:openfda.package_ndc
ndc11	package	00517400225	derived:openfda.package_ndc
rxcui		1789947	openfda.rxcui
spl id		402161da-fe45-4b0f-a5ca-a230593cc434	id
spl set id		9e5e2ce4-7a57-4c61-a826-64c8d11d038e	set_id
unii		23473EC6BQ	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following side effects have been reported: general discomfort, nausea, abdominal discomfort, anorexia, constipation or diarrhea, skin rash, malaise, vertigo, headache, intensive flushing of the face, perspiration, increase in the depth of respiration, increase in heart rate, a slight rise in blood pressure, and excessive sedation. Hepatitis, probably related to an immune mechanism, has been reported infrequently. Rarely, this has progressed to cirrhosis.

Reported adverse events (FAERS/openFDA)#

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