NDC Package 65085-0023-1 Flecainide Acetate

Powder - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:

65085-0023-1

Package Description:

28.5 kg in 1 DRUM

Product Code:

65085-0023

Non-Proprietary Name:

Flecainide Acetate

Substance Name:

Flecainide Acetate

Usage Information:

This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. It is also used to prevent certain types of irregular heartbeat from returning (such as atrial fibrillation). Flecainide is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other effective and possibly safer treatments.

11-Digit NDC Billing Format:

65085002301

Product Type:

Drug For Further Processing

Labeler Name:

Piramal Pharma Limited

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

FLECAINIDE ACETATE 28.5 kg/28.5kg

Sample Package:

N/A

Marketing Category:

DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.

Start Marketing Date:

02-27-2013

Listing Expiration Date:

12-31-2026

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

65085 - Piramal Pharma Limited
- 65085-0023 -
  - 65085-0023-1 - 28.5 kg in 1 DRUM

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
65085-0023-2	50.5 kg in 1 DRUM

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 65085-0023-1?

The NDC Packaged Code 65085-0023-1 is assigned to an UNFINISHED drug package of 28.5 kg in 1 drum of Flecainide Acetate, drug for further processing labeled by Piramal Pharma Limited. The product's dosage form is powder and is administered via form.

Is NDC 65085-0023 included in the NDC Directory?

Yes, Flecainide Acetate is an UNFINISHED PRODUCT with code 65085-0023 that is active and included in the NDC Directory. The product was first marketed by Piramal Pharma Limited on February 27, 2013 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 65085-0023-1?

The 11-digit format is 65085002301. 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 5-4-1 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
5-4-1	65085-0023-1	5-4-2	65085-0023-01

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