Erwinase
NDC 81561-413

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 81561-413?
  4. Active Ingredients UNII Codes
  5. Inactive Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Erwinase is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Porton Biopharma Limited. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 81561-413 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
81561-413
Proprietary Name:
Erwinase
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Porton Biopharma Limited
Labeler Code:
81561
Product Label ID:
bd0f5322-a1d3-79c3-e053-2995a90acd70
HCPCS Code:
J9019 - INJECTION, ASPARAGINASE (ERWINAZE), 1,000 IU
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

Marketing Timeline

Start Marketing Date: [9]
06-01-2021
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 81561-413?

The NDC code 81561-413 is assigned by the FDA to the product Erwinase. This pharmaceutical product is labeled by Porton Biopharma Limited and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 81561-413-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Which are the associated UNII Codes?

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

  • ASPARAGINASE ERWINIA CHRYSANTHEMI (UNII: D733ET3F9O)
  • ASPARAGINASE (UNII: G4FQ3CKY5R) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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 full disclaimer at the bottom of this page.

Patient Education

Asparaginase Erwinia Chrysanthemi (recombinant)-rywn Injection


Asparaginase erwinia chrysanthemi (recombinant)-rywn injection is used with other chemotherapy medications to treat acute lymphocytic leukemia (ALL; a type of cancer of the white blood cells) and to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) in adults and children 1 month of age and older. It is used in people who have had some types of allergic reactions to medications similar to asparaginase erwinia chrysanthemi (recombinant)-rywn such as asparaginase (Elspar). Asparaginase erwinia chrysanthemi (recombinant)-rywn is an enzyme that interferes with natural substances necessary for cancer cell growth. It works by killing or stopping the growth of cancer cells.
[Learn More]


Asparaginase Erwinia Chrysanthemi Injection


Asparaginase erwinia chrysanthemi is used with other chemotherapy medications to treat acute lymphocytic leukemia (ALL; a type of cancer of the white blood cells). It is used in patients who have had some types of allergic reactions to medications similar to asparaginase erwinia chrysanthemi such as (asparaginase [Elspar] or pegaspargase [Oncaspar]). Asparaginase erwinia chrysanthemi is an enzyme that interferes with natural substances necessary for cancer cell growth. It works by killing or stopping the growth of cancer cells.
[Learn More]


Cancer Chemotherapy


What is cancer chemotherapy?

Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

Chemotherapy is used to:

  • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
  • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

What are the side effects of chemotherapy?

Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

Some common side effects are:

There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

What can I expect when getting chemotherapy?

You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

NIH: National Cancer Institute


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".