nitroglycerin

Generic: nitroglycerin

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler american regent, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nitroglycerin 5 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-4810
Product ID 0517-4810_ee83c8b9-c31a-4f32-9e9d-0370545204cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072034
Listing Expiration 2026-12-31
Marketing Start 2003-03-04

Pharmacologic Class

Established (EPC)
nitrate vasodilator [epc]
Chemical Structure
nitrates [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05174810
Hyphenated Format 0517-4810

Supplemental Identifiers

RxCUI
237205
UPC
0305174810258
UNII
G59M7S0WS3
NUI
N0000175415 M0014874 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nitroglycerin (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number ANDA072034 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)
source: ndc

Packages (1)

0517-4810-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)

Ingredients (1)

nitroglycerin (5 mg/mL)

Linked Drug Pages (1)

Nitroglycerin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ee83c8b9-c31a-4f32-9e9d-0370545204cb", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0305174810258"], "unii": ["G59M7S0WS3"], "rxcui": ["237205"], "spl_set_id": ["8c52cdf6-87be-4719-b105-f08be096d462"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25)  / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)", "package_ndc": "0517-4810-25", "marketing_start_date": "20030304"}], "brand_name": "Nitroglycerin", "product_id": "0517-4810_ee83c8b9-c31a-4f32-9e9d-0370545204cb", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0517-4810", "generic_name": "nitroglycerin", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitroglycerin", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "5 mg/mL"}], "application_number": "ANDA072034", "marketing_category": "ANDA", "marketing_start_date": "20030304", "listing_expiration_date": "20261231"}