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NDC 61755-035 Regen-cov

Casirivimab And Imdevimab Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 61755-035?
  4. Regen-cov Uses
  5. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
61755-035
Proprietary Name:
Regen-cov
Non-Proprietary Name: [1]
Casirivimab And Imdevimab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Regeneron Pharmaceuticals, Inc.
Labeler Code:
61755
Product Label ID:
f5bf7a31-7e17-4a94-805c-d231ea458fb0
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
02-07-2021
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 61755-035-02

Package Description: 1 KIT in 1 DOSE PACK * 1 VIAL, GLASS in 1 CARTON (61755-024-01) / 11.1 mL in 1 VIAL, GLASS (61755-024-00) * 1 VIAL, GLASS in 1 CARTON (61755-025-01) / 11.1 mL in 1 VIAL, GLASS (61755-025-00)

Product Details

What is NDC 61755-035?

The NDC code 61755-035 is assigned by the FDA to the product Regen-cov which is a human prescription drug product labeled by Regeneron Pharmaceuticals, Inc.. The generic name of Regen-cov is casirivimab and imdevimab. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 61755-035-02 1 kit in 1 dose pack * 1 vial, glass in 1 carton (61755-024-01) / 11.1 ml in 1 vial, glass (61755-024-00) * 1 vial, glass in 1 carton (61755-025-01) / 11.1 ml in 1 vial, glass (61755-025-00). 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 Regen-cov?

None.

What is the NDC to RxNorm Crosswalk for Regen-cov?

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:

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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] 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".