Vowst Capsule
NDC Package 71881-400-12

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

Package Information

Vowst (fecal microbiota spores, live-brpk) capsules is 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). This formulation utilizes a capsule delivery system. Marketed by Aimmune Therapeutics, Inc., this product is identified by NDC 71881-400 and is authorized under FDA application BLA125757.

Identification & Billing

NDC Package Code
71881-400-12
Package Description
1 BOTTLE in 1 CARTON / 12 CAPSULE in 1 BOTTLE
Product Code
71881-400
11-Digit Billing Format
71881040012
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vowst
Non-Proprietary Name
Fecal Microbiota Spores, Live-brpk
Substance Name
Donor Human Stool Spores (ethanol Treated)
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DONOR HUMAN STOOL SPORES (ETHANOL TREATED) 30000000 [CFU]/1
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).

Regulatory & Marketing

Labeler Name
Aimmune Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125757
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-26-2023
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 71881-400-12 identifies a specific commercial package of 1 bottle in 1 carton / 12 capsule in 1 bottle of Vowst, a human prescription drug labeled by Aimmune Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule is formulated for oral use and contains donor human stool spores (ethanol treated) 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 Aimmune Therapeutics, Inc. on April 26, 2023. The current certification is valid through December 31, 2027.

How is this Aimmune Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71881040012. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
71881-400-12
11-Digit CMS (5-4-2)
71881-0400-12

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