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NDC 59353-0401-09 Mircera 50 ug/.3mL Details
Mircera 50 ug/.3mL
Mircera is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Vifor (International) Inc.. The primary component is METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA.
MedlinePlus Drug Summary
Methoxy polyethylene glycol-epoetin beta injection is 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) in adults on and not on dialysis and in children 5 years of age and older on dialysis who have already received another treatment for anemia. Methoxy polyethylene glycol-epoetin beta injection should not be used to treat anemia caused by cancer chemotherapy and should not be used in place of a red blood cell transfusion to treat severe anemia. Methoxy polyethylene glycol-epoetin beta injection is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
Related Packages: 59353-0401-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Methoxy Polyethylene Glycol-Epoetin Beta Injection
Product Information
| NDC | 59353-0401 |
|---|---|
| Product ID | 59353-401_6a6a2c0d-5fb1-480a-bd41-f959544baef2 |
| Associated GPIs | 8240104010E515 |
| GCN Sequence Number | 063115 |
| GCN Sequence Number Description | methoxy peg-epoetin beta SYRINGE 50 MCG/0.3 INJECTION |
| HIC3 | N1B |
| HIC3 Description | ERYTHROPOIESIS-STIMULATING AGENTS |
| GCN | 98874 |
| HICL Sequence Number | 035005 |
| HICL Sequence Number Description | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
| Brand/Generic | Brand |
| Proprietary Name | Mircera |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Methoxy polyethylene glycol-epoetin beta |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | ug/.3mL |
| Substance Name | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
| Labeler Name | Vifor (International) Inc. |
| Pharmaceutical Class | Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125164 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59353-0401-09 (59353040109)
| NDC Package Code | 59353-401-09 |
|---|---|
| Billing NDC | 59353040109 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (59353-401-09) / 1 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2014-10-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |