Viagra
NDC Package 21695-158-30

11-digit billing NDC: 21695015830 · Billing unit: EA · 30 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Viagra is consistent with its known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY ), VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-158 and is authorized under FDA application NDA020895.

Identification & Billing

NDC Package Code
21695-158-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
21695-158
11-Digit Billing Format
21695015830
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Viagra
Dosage Form
-
Usage Information
Consistent with its known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY ), VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.After patients have taken VIAGRA, it is unknown when nitrates, if necessary, can be safely administered. Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL) (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism ). In the following patients: age >65, hepatic impairment (e.g., cirrhosis), severe renal impairment (e.g., creatinine clearance less than 30 mL/min), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin), plasma levels of sildenafil at 24 hours post dose have been found to be 3 to 8 times higher than those seen in healthy volunteers. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely coadministered at this time point.VIAGRA is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
NDA020895
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-11-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-158-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Viagra, labeled by Rebel Distributors Corp. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on February 11, 2010. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695015830. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
21695-158-30
11-Digit CMS (5-4-2)
21695-0158-30

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