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  5. NDC Package Code: 83461-400-12 Fecal Microbiota Spores, Live-brpk

NDC Package 83461-400-12 Fecal Microbiota Spores, Live-brpk

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

Table of Contents

    1. Package Information
    2. 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:
83461-400-12
Package Description:
79 BOTTLE in 1 BOX / 12 CAPSULE in 1 BOTTLE
Product Code:
83461-400
Non-Proprietary Name:
Fecal Microbiota Spores, Live-brpk
Substance Name:
Donor Human Stool Spores (ethanol Treated)
11-Digit NDC Billing Format:
83461040012
Product Type:
Drug For Further Processing
Labeler Name:
Genibet Biopharmaceuticals
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s):
DONOR HUMAN STOOL SPORES (ETHANOL TREATED) 30000000 [CFU]/1
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:
04-26-2023
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 83461-400-12?

The NDC Packaged Code 83461-400-12 is assigned to an UNFINISHED drug package of 79 bottle in 1 box / 12 capsule in 1 bottle of Fecal Microbiota Spores, Live-brpk, drug for further processing labeled by Genibet Biopharmaceuticals. The product's dosage form is capsule and is administered via form.

Is NDC 83461-400 included in the NDC Directory?

Yes, Fecal Microbiota Spores, Live-brpk is an UNFINISHED PRODUCT with code 83461-400 that is active and included in the NDC Directory. The product was first marketed by Genibet Biopharmaceuticals on April 26, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83461-400-12?

The 11-digit format is 83461040012. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-283461-400-125-4-283461-0400-12