NDC Package 65862-880-60 Tadalafil

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

65862-880-60

Package Description:

60 TABLET in 1 BOTTLE

Product Code:

65862-880

Proprietary Name:

Tadalafil

Non-Proprietary Name:

Tadalafil

Substance Name:

Tadalafil

Usage Information:

Tadalafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise.

11-Digit NDC Billing Format:

65862088060

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

60 EA

NDC to RxNorm Crosswalk:

RxCUI: 2123194 - tadalafil 20 MG Pulmonary Hypertension Oral Tablet

RxCUI: 2123194 - Pulmonary Hypertension tadalafil 20 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Aurobindo Pharma Limited

Dosage Form:

Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

TADALAFIL 20 mg/1

Pharmacologic Class(es):

Phosphodiesterase 5 Inhibitor - [EPC] (Established Pharmacologic Class)

Phosphodiesterase 5 Inhibitors - [MoA] (Mechanism of Action)

Sample Package:

FDA Application Number:

ANDA206286

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

02-05-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

65862 - Aurobindo Pharma Limited
- 65862-880 - Tadalafil
  - 65862-880-60 - 60 TABLET in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 65862-880-60?

The NDC Packaged Code 65862-880-60 is assigned to a package of 60 tablet in 1 bottle of Tadalafil, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet and is administered via oral form.

Is NDC 65862-880 included in the NDC Directory?

Yes, Tadalafil with product code 65862-880 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on February 05, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 65862-880-60?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 65862-880-60?

The 11-digit format is 65862088060. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	65862-880-60	5-4-2	65862-0880-60

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