nitrostat

Generic: nitroglycerin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitrostat
Generic Name nitroglycerin
Labeler viatris specialty llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-310
Product ID 58151-310_793962da-82d4-4fe1-b78d-dccf10a8ff85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021134
Listing Expiration 2026-12-31
Marketing Start 2024-02-02

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 58151310
Hyphenated Format 58151-310

Supplemental Identifiers

RxCUI
198038 198039 198040 207331 207346 207361
UPC
0358151309016 0358151311019
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 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
  • 1 BOTTLE in 1 CARTON (58151-310-01) / 100 TABLET in 1 BOTTLE
  • 4 BOTTLE in 1 CARTON (58151-310-52) / 25 TABLET in 1 BOTTLE (58151-310-94)
source: ndc

Packages (2)

58151-310-01 1 BOTTLE in 1 CARTON (58151-310-01) / 100 TABLET in 1 BOTTLE 58151-310-52 4 BOTTLE in 1 CARTON (58151-310-52) / 25 TABLET in 1 BOTTLE (58151-310-94)

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": "793962da-82d4-4fe1-b78d-dccf10a8ff85", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0358151309016", "0358151311019"], "unii": ["G59M7S0WS3"], "rxcui": ["198038", "198039", "198040", "207331", "207346", "207361"], "spl_set_id": ["9a52da75-d0af-4237-96c0-0b12adfa8636"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58151-310-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "58151-310-01", "marketing_start_date": "20240202"}, {"sample": false, "description": "4 BOTTLE in 1 CARTON (58151-310-52)  / 25 TABLET in 1 BOTTLE (58151-310-94)", "package_ndc": "58151-310-52", "marketing_start_date": "20240202"}], "brand_name": "Nitrostat", "product_id": "58151-310_793962da-82d4-4fe1-b78d-dccf10a8ff85", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "58151-310", "generic_name": "nitroglycerin", "labeler_name": "Viatris Specialty LLC", "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": "20240202", "listing_expiration_date": "20261231"}