nitroglycerin

Generic: nitroglycerin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler proficient rx lp
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-122
Product ID 82804-122_41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93
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 82804122
Hyphenated Format 82804-122

Supplemental Identifiers

RxCUI
198039
UPC
0382804122257
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
  • 1 BOTTLE in 1 CARTON (82804-122-25) / 25 TABLET in 1 BOTTLE
source: ndc

Packages (1)

82804-122-25 1 BOTTLE in 1 CARTON (82804-122-25) / 25 TABLET in 1 BOTTLE

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": "41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0382804122257"], "unii": ["G59M7S0WS3"], "rxcui": ["198039"], "spl_set_id": ["41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82804-122-25)  / 25 TABLET in 1 BOTTLE", "package_ndc": "82804-122-25", "marketing_start_date": "20240711"}], "brand_name": "Nitroglycerin", "product_id": "82804-122_41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "82804-122", "generic_name": "Nitroglycerin", "labeler_name": "Proficient Rx LP", "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"}