nitroglycerin

Generic: nitroglycerin

Labeler: trupharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitroglycerin
Generic Name nitroglycerin
Labeler trupharma, llc
Dosage Form OINTMENT
Routes
RECTAL
Active Ingredients

nitroglycerin 4 mg/g

Manufacturer
Trupharma, LLC

Identifiers & Regulatory

Product NDC 52817-835
Product ID 52817-835_28693a60-dc7a-eacb-e063-6394a90ae222
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212222
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

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 52817835
Hyphenated Format 52817-835

Supplemental Identifiers

RxCUI
1114466
UPC
0352817835307
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 ANDA212222 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (52817-835-30) / 30 g in 1 TUBE
source: ndc

Packages (1)

52817-835-30 1 TUBE in 1 CARTON (52817-835-30) / 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": "28693a60-dc7a-eacb-e063-6394a90ae222", "openfda": {"nui": ["N0000175415", "M0014874", "N0000009909"], "upc": ["0352817835307"], "unii": ["G59M7S0WS3"], "rxcui": ["1114466"], "spl_set_id": ["543ef8c8-d520-461b-bf6e-f8d8c277feec"], "pharm_class_cs": ["Nitrates [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Nitrate Vasodilator [EPC]"], "manufacturer_name": ["Trupharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (52817-835-30)  / 30 g in 1 TUBE", "package_ndc": "52817-835-30", "marketing_start_date": "20241202"}], "brand_name": "NITROGLYCERIN", "product_id": "52817-835_28693a60-dc7a-eacb-e063-6394a90ae222", "dosage_form": "OINTMENT", "pharm_class": ["Nitrate Vasodilator [EPC]", "Nitrates [CS]", "Vasodilation [PE]"], "product_ndc": "52817-835", "generic_name": "Nitroglycerin", "labeler_name": "Trupharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITROGLYCERIN", "active_ingredients": [{"name": "NITROGLYCERIN", "strength": "4 mg/g"}], "application_number": "ANDA212222", "marketing_category": "ANDA", "marketing_start_date": "20241202", "listing_expiration_date": "20261231"}