NDC 0024-5841 Zaltrap
Ziv-aflibercept Solution, Concentrate Intravenous

Product Information

NDC Product Code0024-5841
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.
Zaltrap
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.
Ziv-aflibercept
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Aflibercept
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 FormSolution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Sanofi-aventis U.s. Llc
Labeler Code0024
SPL SET ID:f6725df6-50ee-4b0a-b900-d02ba634395d
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.
BLA125418
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.
08-03-2012
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.
12-31-2023
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 0024-5841-01

Package Description: 1 VIAL in 1 CARTON / 8 mL in 1 VIAL

Product Details

What is NDC 0024-5841?

The NDC code 0024-5841 is assigned by the FDA to the product Zaltrap which is a human prescription drug product labeled by Sanofi-aventis U.s. Llc. The generic name of Zaltrap is ziv-aflibercept. The product's dosage form is solution, concentrate and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0024-5841-01 1 vial in 1 carton / 8 ml in 1 vial. 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 Zaltrap?

Ziv-aflibercept is used to treat cancer of the colon and rectum. ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

What are Zaltrap Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Zaltrap Inactive Ingredients 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 Zaltrap?

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:

Which are the Pharmacologic Classes for Zaltrap?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Aflibercept Injection


Aflibercept injection is used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities). It is also used to treat macular edema after retinal vein occlusion (an eye disease caused by blockage of blood flow from the eye that leads to blurry vision and vision loss), diabetic macular edema (an eye disease caused by diabetes that can lead to vision loss), and diabetic retinopathy (damage to the eyes caused by diabetes). Aflibercept injection is also used to treat retinopathy of prematurity (ROP; an eye disease that occurs in premature infants that can lead to vision loss and blindness). Aflibercept injection is in a class of medications called vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonists. It works by stopping abnormal blood vessel growth and leakage in the eye(s) that may cause vision loss in people with certain eye conditions.
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Ziv-aflibercept Injection


Ziv-aflibercept injection is used in combination with other medications to treat cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Ziv-aflibercept is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.
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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


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* Please review the disclaimer below.

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