nitrostat

Generic: nitroglycerin

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

Drug Facts

Product Profile

Brand Name nitrostat
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 63187-884
Product ID 63187-884_3195d486-86b4-4ee4-b049-a1ad55e9ab06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021134
Listing Expiration 2026-12-31
Marketing Start 2000-05-01

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 63187884
Hyphenated Format 63187-884

Supplemental Identifiers

RxCUI
198039 207346
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 nitrostat (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number NDA021134 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 25 TABLET in 1 BOTTLE (63187-884-25)
source: ndc

Packages (1)

63187-884-25 25 TABLET in 1 BOTTLE (63187-884-25)

Ingredients (1)

nitroglycerin (.4 mg/1)

Linked Drug Pages (1)

Nitrostat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "3195d486-86b4-4ee4-b049-a1ad55e9ab06", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["198039", "207346"], "spl_set_id": ["6fe3965f-0dd8-4bae-9771-de25074cb1b0"], "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": "25 TABLET in 1 BOTTLE (63187-884-25)", "package_ndc": "63187-884-25", "marketing_start_date": "20171002"}], "brand_name": "Nitrostat", "product_id": "63187-884_3195d486-86b4-4ee4-b049-a1ad55e9ab06", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "63187-884", "generic_name": "nitroglycerin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitrostat", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".4 mg/1"}], "application_number": "NDA021134", "marketing_category": "NDA", "marketing_start_date": "20000501", "listing_expiration_date": "20261231"}