nitroglycerin

Generic: nitroglycerin

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler propharma distribution
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-639
Product ID 84549-639_3d71f76d-bb21-7251-e063-6394a90aa9d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206391
Listing Expiration 2026-12-31
Marketing Start 2017-09-19

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 84549639
Hyphenated Format 84549-639

Supplemental Identifiers

RxCUI
198039
UNII
G59M7S0WS3
NUI
N0000175415 M0014874 N0000009909

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 ANDA206391 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 25 TABLET in 1 BOTTLE (84549-639-45)
source: ndc

Packages (1)

84549-639-45 25 TABLET in 1 BOTTLE (84549-639-45)

Ingredients (1)

nitroglycerin (.4 mg/1)

Linked Drug Pages (1)

Nitroglycerin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "3d71f76d-bb21-7251-e063-6394a90aa9d8", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["198039"], "spl_set_id": ["3d71f76d-bb22-7251-e063-6394a90aa9d8"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET in 1 BOTTLE (84549-639-45)", "package_ndc": "84549-639-45", "marketing_start_date": "20250901"}], "brand_name": "Nitroglycerin", "product_id": "84549-639_3d71f76d-bb21-7251-e063-6394a90aa9d8", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "84549-639", "generic_name": "Nitroglycerin", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitroglycerin", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".4 mg/1"}], "application_number": "ANDA206391", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}