nitroglycerin

Generic: nitroglycerin

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler sportpharm, inc. dba sportpharm
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

nitroglycerin .4 mg/1

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-116
Product ID 85766-116_42702eaf-691b-c83e-e063-6294a90ac678
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211604
Listing Expiration 2026-12-31
Marketing Start 2022-10-03

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 85766116
Hyphenated Format 85766-116

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 ANDA211604 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • .4 mg/1
source: ndc
Packaging
  • 4 BOTTLE in 1 CARTON (85766-116-00) / 25 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (85766-116-01) / 100 TABLET in 1 BOTTLE
  • 10 TABLET in 1 BOTTLE (85766-116-10)
  • 20 TABLET in 1 BOTTLE (85766-116-20)
  • 25 TABLET in 1 BOTTLE (85766-116-25)
  • 30 TABLET in 1 BOTTLE (85766-116-30)
  • 60 TABLET in 1 BOTTLE (85766-116-60)
  • 90 TABLET in 1 BOTTLE (85766-116-90)
source: ndc

Packages (8)

85766-116-00 4 BOTTLE in 1 CARTON (85766-116-00) / 25 TABLET in 1 BOTTLE 85766-116-01 1 BOTTLE in 1 CARTON (85766-116-01) / 100 TABLET in 1 BOTTLE 85766-116-10 10 TABLET in 1 BOTTLE (85766-116-10) 85766-116-20 20 TABLET in 1 BOTTLE (85766-116-20) 85766-116-25 25 TABLET in 1 BOTTLE (85766-116-25) 85766-116-30 30 TABLET in 1 BOTTLE (85766-116-30) 85766-116-60 60 TABLET in 1 BOTTLE (85766-116-60) 85766-116-90 90 TABLET in 1 BOTTLE (85766-116-90)

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": "42702eaf-691b-c83e-e063-6294a90ac678", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["198039"], "spl_set_id": ["84739085-81df-4a43-8456-c9edfbf971e9"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE in 1 CARTON (85766-116-00)  / 25 TABLET in 1 BOTTLE", "package_ndc": "85766-116-00", "marketing_start_date": "20251031"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (85766-116-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "85766-116-01", "marketing_start_date": "20251031"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (85766-116-10)", "package_ndc": "85766-116-10", "marketing_start_date": "20251031"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (85766-116-20)", "package_ndc": "85766-116-20", "marketing_start_date": "20251031"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE (85766-116-25)", "package_ndc": "85766-116-25", "marketing_start_date": "20251031"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (85766-116-30)", "package_ndc": "85766-116-30", "marketing_start_date": "20251031"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (85766-116-60)", "package_ndc": "85766-116-60", "marketing_start_date": "20251031"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (85766-116-90)", "package_ndc": "85766-116-90", "marketing_start_date": "20251031"}], "brand_name": "NITROGLYCERIN", "product_id": "85766-116_42702eaf-691b-c83e-e063-6294a90ac678", "dosage_form": "TABLET", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "85766-116", "generic_name": "NITROGLYCERIN", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": ".4 mg/1"}], "application_number": "ANDA211604", "marketing_category": "ANDA", "marketing_start_date": "20221003", "listing_expiration_date": "20261231"}