Rectiv Ointment
NDC Package 58914-301-85

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Rectiv (nitroglycerin) ointment is nitroglycerin ointment is used to treat moderate to severe pain caused by long-term tears in the lining of the anus (anal fissures). This formulation utilizes a ointment delivery system. Marketed by Allergan, Inc., this product is identified by NDC 58914-301 and is authorized under FDA application NDA021359.

Identification & Billing

NDC Package Code
58914-301-85
Package Description
1 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
58914-301
11-Digit Billing Format
58914030185
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rectiv
Non-Proprietary Name
Nitroglycerin
Substance Name
Nitroglycerin
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
NITROGLYCERIN 4 mg/g
Pharmacologic Class
Usage Information
Nitroglycerin ointment is used to treat moderate to severe pain caused by long-term tears in the lining of the anus (anal fissures). This medication works by relaxing the muscles around the blood vessels which reduces pressure inside the anus and relieves pain. Nitroglycerin belongs to a class of drugs known as nitrates.

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021359
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-21-2011
End Marketing Date
02-28-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58914-301). Click a package code to view its specific billing and regulatory data.

58914-301-80
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 58914-301-85 identifies a specific commercial package of 1 tube in 1 carton / 5 g in 1 tube of Rectiv, a human prescription drug labeled by Allergan, Inc.. This ointment is formulated for rectal 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 Allergan, Inc. on June 21, 2011.

What are the primary indications for this medication?

Nitroglycerin ointment is used to treat moderate to severe pain caused by long-term tears in the lining of the anus (anal fissures). This medication works by relaxing the muscles around the blood vessels which reduces pressure inside the anus and relieves pain. Nitroglycerin belongs to a class of drugs known as nitrates.

How is this Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58914030185. 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 (5-3-2)
58914-301-85
11-Digit CMS (5-4-2)
58914-0301-85

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