nitroglycerin

Generic: nitroglycerin

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler encube ethicals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

nitroglycerin 20 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-054
Product ID 21922-054_4ebf07d0-9435-4756-b67d-23ed0fcd4279
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218235
Listing Expiration 2026-12-31
Marketing Start 2025-04-16

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 21922054
Hyphenated Format 21922-054

Supplemental Identifiers

RxCUI
242946
UPC
0321922054477 0321922054057
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 nitroglycerin (source: ndc)
Generic Name nitroglycerin (source: ndc)
Application Number ANDA218235 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-054-05) / 30 g in 1 TUBE
  • 48 POUCH in 1 CARTON (21922-054-47) / 1 g in 1 POUCH (21922-054-59)
source: ndc

Packages (2)

Ingredients (1)

nitroglycerin (20 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "4ebf07d0-9435-4756-b67d-23ed0fcd4279", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0321922054477", "0321922054057"], "unii": ["G59M7S0WS3"], "rxcui": ["242946"], "spl_set_id": ["c17c997b-0e90-4105-888b-2de22d2bf697"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-054-05)  / 30 g in 1 TUBE", "package_ndc": "21922-054-05", "marketing_start_date": "20250416"}, {"sample": false, "description": "48 POUCH in 1 CARTON (21922-054-47)  / 1 g in 1 POUCH (21922-054-59)", "package_ndc": "21922-054-47", "marketing_start_date": "20250416"}], "brand_name": "NITROGLYCERIN", "product_id": "21922-054_4ebf07d0-9435-4756-b67d-23ed0fcd4279", "dosage_form": "OINTMENT", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "21922-054", "generic_name": "Nitroglycerin", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "20 mg/g"}], "application_number": "ANDA218235", "marketing_category": "ANDA", "marketing_start_date": "20250416", "listing_expiration_date": "20261231"}