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NDC 55513-0148-10 EPOGEN 4000 [iU]/mL Details
EPOGEN 4000 [iU]/mL
EPOGEN is a INTRAVENOUS; SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is EPOETIN.
MedlinePlus Drug Summary
Epoetin alfa injection products are used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa injection products are also used to treat anemia caused by chemotherapy in people with certain types of cancer or caused by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV). Epoetin alfa injection products are also used before and after certain types of surgery to decrease the chance that blood transfusions (transfer of one person's blood to another person's body) will be needed because of blood loss during surgery. Epoetin alfa injection products should not be used to decrease the risk that transfusions will be needed in people who are having surgery on their hearts or blood vessels. Epoetin alfa injection products also should not be used to treat people who are able and willing to donate blood before surgery so that this blood can be replaced in their bodies during or after surgery. Epoetin alfa injection products cannot be used in place of a red blood cell transfusion to treat severe anemia and has not been shown to improve tiredness or poor well-being that may be caused by anemia. Epoetin alfa products are in a class of medications called erythropoiesis-stimulating agents (ESAs). They work by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
Related Packages: 55513-0148-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Epoetin Alfa, Injection
Product Information
NDC | 55513-0148 |
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Product ID | 55513-148_24d7c973-9b2d-4b32-baf5-0bcde9ce4c9b |
Associated GPIs | 82401020002020 |
GCN Sequence Number | 011741 |
GCN Sequence Number Description | epoetin alfa VIAL 4000/ML INJECTION |
HIC3 | N1B |
HIC3 Description | ERYTHROPOIESIS-STIMULATING AGENTS |
GCN | 25111 |
HICL Sequence Number | 004553 |
HICL Sequence Number Description | EPOETIN ALFA |
Brand/Generic | Brand |
Proprietary Name | EPOGEN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | epoetin alfa |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION |
Route | INTRAVENOUS; SUBCUTANEOUS |
Active Ingredient Strength | 4000 |
Active Ingredient Units | [iU]/mL |
Substance Name | EPOETIN |
Labeler Name | Amgen Inc |
Pharmaceutical Class | Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA103234 |
Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0148-10 (55513014810)
NDC Package Code | 55513-148-10 |
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Billing NDC | 55513014810 |
Package | 10 VIAL in 1 PACKAGE (55513-148-10) / 1 mL in 1 VIAL (55513-148-01) |
Marketing Start Date | 1993-08-16 |
NDC Exclude Flag | N |
Pricing Information | N/A |