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  5. NDC Package Code: 71881-400-12 Vowst

NDC Package 71881-400-12 Vowst

Fecal Microbiota Spores,Live-brpk Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
71881-400-12
Package Description:
1 BOTTLE in 1 CARTON / 12 CAPSULE in 1 BOTTLE
Product Code:
71881-400
Proprietary Name:
Vowst
Non-Proprietary Name:
Fecal Microbiota Spores, Live-brpk
Substance Name:
Donor Human Stool Spores (ethanol Treated)
Usage Information:
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
11-Digit NDC Billing Format:
71881040012
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2636542 - fecal microbiota spores, live-brpk 30,000,000 UNT Oral Capsule
  • RxCUI: 2636542 - fecal microbiota spores, live-brpk 30000000 UNT Oral Capsule
  • RxCUI: 2636548 - VOWST 30,000,000 UNT Oral Capsule
  • RxCUI: 2636548 - fecal microbiota spores, live-brpk 30000000 UNT Oral Capsule [Vowst]
  • RxCUI: 2636548 - Vowst 30000000 UNT Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aimmune Therapeutics, Inc.
    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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DONOR HUMAN STOOL SPORES (ETHANOL TREATED) 30000000 [CFU]/1
    • Sample Package:
    No
    FDA Application Number:
    BLA125757
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-26-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 71881-400-12?

    The NDC Packaged Code 71881-400-12 is assigned to a package of 1 bottle in 1 carton / 12 capsule in 1 bottle of Vowst, a human prescription drug labeled by Aimmune Therapeutics, Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 71881-400 included in the NDC Directory?

    Yes, Vowst with product code 71881-400 is active and included in the NDC Directory. The product was first marketed by Aimmune Therapeutics, Inc. on April 26, 2023 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 71881-400-12?

    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 1.

    What is the 11-digit format for NDC 71881-400-12?

    The 11-digit format is 71881040012. 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
    5-3-271881-400-125-4-271881-0400-12