Nitroglycerin Injection, Solution
NDC Package 70518-4232-0

11-digit billing NDC: 70518423200
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nitroglycerin injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and β-blockers; and for induction of intraoperative hypotension. This formulation utilizes a injection, solution delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4232 and is authorized under FDA application ANDA072034.

Identification & Billing

NDC Package Code
70518-4232-0
Package Description
25 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4232-1)
Product Code
70518-4232
11-Digit Billing Format
70518423200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nitroglycerin
Non-Proprietary Name
Nitroglycerin
Substance Name
Nitroglycerin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NITROGLYCERIN 5 mg/mL
Pharmacologic Class
Usage Information
Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and β-blockers; and for induction of intraoperative hypotension.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA072034
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4232-0 identifies a specific commercial package of 25 vial, single-dose in 1 tray / 10 ml in 1 vial, single-dose (70518-4232-1) of Nitroglycerin, a human prescription drug labeled by Remedyrepack Inc.. This injection, solution is formulated for intravenous use and contains nitroglycerin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Remedyrepack Inc. on November 14, 2024. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518423200. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
70518-4232-0
11-Digit CMS (5-4-2)
70518-4232-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.