Guanfacine Tablet
NDC Package 27241-243-01

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

Package Information

Guanfacine tablets is uSP are indicated in the management of hypertension. This formulation utilizes a tablet delivery system. Marketed by Ajanta Pharma Usa Inc., this product is identified by NDC 27241-243 and is authorized under FDA application ANDA217293.

Identification & Billing

NDC Package Code
27241-243-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
27241-243
11-Digit Billing Format
27241024301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Guanfacine
Non-Proprietary Name
Guanfacine
Substance Name
Guanfacine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUANFACINE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Regulatory & Marketing

Labeler Name
Ajanta Pharma Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217293
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-27-2023
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 27241-243-01 identifies a specific commercial package of 100 tablet in 1 bottle of Guanfacine, a human prescription drug labeled by Ajanta Pharma Usa Inc.. This tablet is formulated for oral use and contains guanfacine hydrochloride 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 Ajanta Pharma Usa Inc. on April 27, 2023. The current certification is valid through December 31, 2027.

How is this Ajanta Pharma Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27241024301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
27241-243-01
11-Digit CMS (5-4-2)
27241-0243-01

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