nitrostat

Generic: nitroglycerin tablet

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrostat
Generic Name nitroglycerin tablet
Labeler henry schein, inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9800
Product ID 0404-9800_32b2fbb8-8769-4399-9cb6-7183cb7072ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021134
Listing Expiration 2026-12-31
Marketing Start 2024-09-17

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 04049800
Hyphenated Format 0404-9800

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 tablet (source: ndc)
Application Number NDA021134 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0404-9800-01 1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLE

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": "32b2fbb8-8769-4399-9cb6-7183cb7072ff", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["198039", "207346"], "spl_set_id": ["5265648f-3062-48a2-a4e3-fea1207807a8"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BAG (0404-9800-01)  / 25 TABLET in 1 BOTTLE", "package_ndc": "0404-9800-01", "marketing_start_date": "20240917"}], "brand_name": "NITROSTAT", "product_id": "0404-9800_32b2fbb8-8769-4399-9cb6-7183cb7072ff", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "0404-9800", "generic_name": "nitroglycerin tablet", "labeler_name": "Henry Schein, Inc.", "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": "20240917", "listing_expiration_date": "20261231"}