NITROGLYCERIN

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: NITROGLYCERIN
Generic name: NITROGLYCERIN
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: c20e89b4-57b5-259d-e053-2a95a90a0038
SPL ID: 2b37f407-bc60-6054-e063-6394a90ada02
Version: 6
Effective date: 2025-01-08
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:20:43

Harmonized routes table
Harmonized routes
SUBLINGUAL

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	208191	derived:openfda.application_number
application number		ANDA208191	openfda.application_number
brand name		NITROGLYCERIN	openfda.brand_name
generic name		NITROGLYCERIN	openfda.generic_name
manufacturer name		HF Acquisition Co LLC, DBA HealthFirst	openfda.manufacturer_name
ndc	package	51662-1282-3	openfda.package_ndc
ndc	package	51662-1282-2	openfda.package_ndc
ndc	product	51662-1282	openfda.product_ndc
ndc11	package	51662128202	derived:openfda.package_ndc
ndc11	package	51662128203	derived:openfda.package_ndc
rxcui		198039	openfda.rxcui
spl id		2b37f407-bc60-6054-e063-6394a90ada02	id
spl set id		c20e89b4-57b5-259d-e053-2a95a90a0038	set_id
unii		G59M7S0WS3	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS The benefits of sublingual nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used because of the possibility of hypotension and tachycardia.

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 Headache that may be severe and persistent may occur immediately after use. Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported. Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

Reported adverse events (FAERS/openFDA)#

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