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
RECTAL
Active Ingredients

nitroglycerin 4 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-048
Product ID 21922-048_cc9f786f-9281-420d-876a-e043592cc148
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216452
Listing Expiration 2026-12-31
Marketing Start 2024-12-17

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 21922048
Hyphenated Format 21922-048

Supplemental Identifiers

RxCUI
1114466
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 ANDA216452 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-048-05) / 30 g in 1 TUBE
source: ndc

Packages (1)

21922-048-05 1 TUBE in 1 CARTON (21922-048-05) / 30 g in 1 TUBE

Ingredients (1)

nitroglycerin (4 mg/g)

Linked Drug Pages (1)

NITROGLYCERIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RECTAL"], "spl_id": "cc9f786f-9281-420d-876a-e043592cc148", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "unii": ["G59M7S0WS3"], "rxcui": ["1114466"], "spl_set_id": ["7bcead76-a90f-4140-9c73-4339d981a084"], "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 (21922-048-05)  / 30 g in 1 TUBE", "package_ndc": "21922-048-05", "marketing_start_date": "20241217"}], "brand_name": "NITROGLYCERIN", "product_id": "21922-048_cc9f786f-9281-420d-876a-e043592cc148", "dosage_form": "OINTMENT", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "21922-048", "generic_name": "Nitroglycerin", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "4 mg/g"}], "application_number": "ANDA216452", "marketing_category": "ANDA", "marketing_start_date": "20241217", "listing_expiration_date": "20261231"}