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NDC 70121-1568-01 RELEUKO 300 ug/.5mL Details
RELEUKO 300 ug/.5mL
RELEUKO is a INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is FILGRASTIM.
MedlinePlus Drug Summary
Filgrastim injection products (Granix, Neupogen, Nivestym, Releuko, Zarxio) are used to decrease the chance of infection in people who have non myeloid cancer (cancer that does not involve the bone marrow) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Filgrastim injection products (Neupogen, Nivestym, Releuko, Zarxio) are also used to help increase the number of white blood cells, and decrease the length of time with fever in people with acute myeloid leukemia (AML; a type of cancer of the white blood cells) who are receiving treatment with chemotherapy medications. Filgrastim injection products (Neupogen, Nivestym, Releuko, Zarxio) are also used in people who are undergoing bone marrow transplants and in people who have severe chronic neutropenia (condition in which there are a low number of neutrophils in the blood). Filgrastim injection products (Neupogen, Nivestym, Zarxio) are also used to prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body. Filgrastim injection (Neupogen) is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to your bone marrow. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils.
Related Packages: 70121-1568-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Filgrastim Injection
Product Information
NDC | 70121-1568 |
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Product ID | 70121-1568_453cee35-313d-43db-ad1a-ce8fe5d3a56c |
Associated GPIs | 8240152015E520 |
GCN Sequence Number | 083115 |
GCN Sequence Number Description | filgrastim-ayow SYRINGE 300MCG/0.5 SUBCUT |
HIC3 | N1C |
HIC3 Description | LEUKOCYTE (WBC) STIMULANTS |
GCN | 51988 |
HICL Sequence Number | 047848 |
HICL Sequence Number Description | FILGRASTIM-AYOW |
Brand/Generic | Brand |
Proprietary Name | RELEUKO |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Filgrastim |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAVENOUS; SUBCUTANEOUS |
Active Ingredient Strength | 300 |
Active Ingredient Units | ug/.5mL |
Substance Name | FILGRASTIM |
Labeler Name | Amneal Pharmaceuticals LLC |
Pharmaceutical Class | Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761082 |
Listing Certified Through | 2024-12-31 |
Package
NDC 70121-1568-01 (70121156801)
NDC Package Code | 70121-1568-1 |
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Billing NDC | 70121156801 |
Package | 1 SYRINGE in 1 BOX (70121-1568-1) / .5 mL in 1 SYRINGE |
Marketing Start Date | 2022-02-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |