Prescription drug · BLA
Mircera (methoxy polyethylene glycol-epoetin beta) NDC 59353-403
Methoxy polyethylene glycol-epoetin beta 100 ug/.3mL · Injection, Solution · Intravenous · Vifor (International) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59353-403-09 | 59353040309 | 1 SYRINGE, GLASS in 1 CARTON (59353-403-09) / 1 mL in 1 SYRINGE, GLASSMarketed from Oct 24, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mircera
- Generic name (nonproprietary)
- methoxy polyethylene glycol-epoetin beta
- Active ingredients
- Methoxy polyethylene glycol-epoetin beta — 100 ug/.3mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Vifor (International) Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125164
- Marketing start
- Listing expires
- Other FDA classes
- Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)
- Identifiers
- Product ID 59353-403_0a85c353-f0fe-4bdb-843e-47264785e209SPL ID 0a85c353-f0fe-4bdb-843e-47264785e209SPL set ID 22c56f2a-f73c-60e7-e054-00144ff88e88RxCUI 758159, 758160, 758162, 758164, 758169, 804171, 1591961, 1591964, 1591967, 1591970, 1591973, 1591976, 1792483, 1792485, 1792488, 1792490, 1792493, 1792495UNII LR3UXN0193
- Pharmacologic class
- Erythropoiesis-stimulating Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N459353040309followed by a unit qualifier and the quantityPackage 59353-0403-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: • adult patients on dialysis and adult patients not on dialysis ( 1.1 ). • pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA ( 1.1 ). Limitations of Use Mircera is not indicated and is not recommended for use: • In the treatment of anemia due to cancer chemotherapy ( 5.2 ). • As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 12.2 ). Mircera has not been shown to improve quality of life, fatigu…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125164
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 50 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-401 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 30 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-400 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 200 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-405 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 75 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-402 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 150 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-404 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 360 ug/.6mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-408 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 250 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-406 |
| Mirceramethoxy polyethylene glycol-epoetin beta | Methoxy polyethylene glycol-epoetin beta 120 ug/.3mL | Injection, SolutionIntravenous | Vifor (International) Inc. | 59353-407 |