NDC 71881-107 Palforzia (level 7)
Peanut Kit

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 71881-107?
    4. Palforzia (level 7) Uses
    5. Active Ingredients UNII Codes
    6. NDC to RxNorm Crosswalk

Product Information

NDC Product Code71881-107
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Palforzia (level 7)
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Peanut
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Aimmune Therapeutics
Labeler Code71881
SPL SET ID:17f5be03-6705-4ac9-b8f3-bc4993ebc0eb
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		BLA125696
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-31-2020
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Packages

NDC Code 71881-107-30

Package Description: 15 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK * 1 POWDER in 1 CAPSULE (71881-124-01) * 1 POWDER in 1 CAPSULE (71881-125-01)

NDC Code 71881-107-99

Package Description: 12 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (71881-107-09) * 1 POWDER in 1 CAPSULE (71881-124-01) * 1 POWDER in 1 CAPSULE (71881-125-01)

Product Details

What is NDC 71881-107?

The NDC code 71881-107 is assigned by the FDA to the product Palforzia (level 7) which is a human prescription drug product labeled by Aimmune Therapeutics. The generic name of Palforzia (level 7) is peanut. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 71881-107-30 15 blister pack in 1 package / 1 kit in 1 blister pack * 1 powder in 1 capsule (71881-124-01) * 1 powder in 1 capsule (71881-125-01), 71881-107-99 12 blister pack in 1 carton / 1 kit in 1 blister pack (71881-107-09) * 1 powder in 1 capsule (71881-124-01) * 1 powder in 1 capsule (71881-125-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Palforzia (level 7)?

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.

Which are Palforzia (level 7) UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Palforzia (level 7)?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2279407 - peanut (Arachis hypogaea) allergen-dnfp 0.5 MG Oral Powder
  • RxCUI: 2279409 - peanut (Arachis hypogaea) allergen-dnfp 1 MG Oral Powder
  • RxCUI: 2279410 - {2 (peanut (Arachis hypogaea) allergen-dnfp 0.5 MG Oral Powder) / 11 (peanut (Arachis hypogaea) allergen-dnfp 1 MG Oral Powder) } Pack
  • RxCUI: 2279410 - peanut (Arachis hypogaea) allergen powder-dnfp Initial Dose Escalation Kit
  • RxCUI: 2279416 - Palforzia 0.5 MG Oral Powder

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