Palforzia
NDC Package 71881-101-45

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Palforzia is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Marketed by Aimmune Therapeutics, Inc., this product is identified by NDC 71881-101 and is authorized under FDA application BLA125696.

Identification & Billing

NDC Package Code
71881-101-45
Package Description
45 CAPSULE in 1 BLISTER PACK / 1 POWDER in 1 CAPSULE
Product Code
71881-101
11-Digit Billing Format
71881010145
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
45 EA

Clinical Specifications

Proprietary Name
Palforzia (level 1)
Dosage Form
-
Usage Information
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older [see Dosage and Administration (2.4)] . PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

Regulatory & Marketing

Labeler Name
Aimmune Therapeutics, Inc.
FDA Application #
BLA125696
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-31-2020
End Marketing Date
01-31-2026
Listing Expiration
01-31-2026
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71881-101). Click a package code to view its specific billing and regulatory data.

71881-101-99
18 BLISTER PACK in 1 CARTON / 3 CAPSULE in 1 BLISTER PACK (71881-101-09) / 1 POWDER in 1 CAPSULE

* 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 71881-101-45 identifies a specific commercial package of 45 capsule in 1 blister pack / 1 powder in 1 capsule of Palforzia (level 1), labeled by Aimmune Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 45 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aimmune Therapeutics, Inc. on January 31, 2020. The current certification is valid through January 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71881010145. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 45 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)
71881-101-45
11-Digit CMS (5-4-2)
71881-0101-45

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