NITROGLYCERIN
Nitroglycerin Ointment USP, 2% FOR TOPICAL USE ONLY Rx Only
Approved
Approval ID
c17c997b-0e90-4105-888b-2de22d2bf697
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-054
Application NumberANDA218235
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (4)
NITROGLYCERINActive
Quantity: 20 mg in 1 g
Code: G59M7S0WS3
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/17/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/17/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/17/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/17/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/17/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/17/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/17/2025
PRECAUTIONS SECTION
LOINC: 42232-9Updated: 4/17/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/17/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/17/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/17/2025
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/17/2025