Prescription drug · BLA
Retacrit (epoetin alfa-epbx) NDC 0069-1311
Epoetin 20000 [iU]/mL · Injection, Solution · Intravenous, Subcutaneous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-1311-10 | 00069131110 | 10 VIAL, MULTI-DOSE in 1 CARTON (0069-1311-10) / 1 mL in 1 VIAL, MULTI-DOSE (0069-1311-01)Marketed from Nov 9, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Retacrit
- Generic name (nonproprietary)
- epoetin alfa-epbx
- Active ingredients
- Epoetin — 20000 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous, Subcutaneous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125545
- Marketing start
- Listing expires
- Other FDA classes
- Erythropoietin (Chemical structure)Increased Erythroid Cell Production (Physiologic effect)
- Identifiers
- Product ID 0069-1311_a2e74269-0093-454f-963e-35c7c2f4f1baSPL ID a2e74269-0093-454f-963e-35c7c2f4f1baSPL set ID 3af26b0d-8ad0-44e1-a538-8bdb5ab39374RxCUI 2047591, 2047596, 2047600, 2047602, 2047606, 2047608, 2047612, 2047614, 2047621, 2047623, 2463731, 2463733, 2463735, 2463737UNII 64FS3BFH5W
- 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
N400069131110followed by a unit qualifier and the quantityPackage 00069-1311-10. 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)
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: • Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). RETACRIT is not indicated f…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125545
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 |
|---|---|---|---|---|
| Retacritepoetin alfa-epbx | Epoetin 4000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-004 |
| Retacritepoetin alfa-epbx | Epoetin 2000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-002 |
| Retacritepoetin alfa-epbx | Epoetin 3000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-003 |
| Retacritepoetin alfa-epbx | Epoetin 10000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-010 |
| Retacritepoetin alfa-epbx | Epoetin 20000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-120 |
| Retacritepoetin alfa-epbx | Epoetin 10000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Vifor (International) Inc. | 59353-220 |
| Retacritepoetin alfa-epbx | Epoetin 4000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1307 |
| Retacritepoetin alfa-epbx | Epoetin 2000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1305 |
| Retacritepoetin alfa-epbx | Epoetin 10000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1318 |
| Retacritepoetin alfa-epbx | Epoetin 40000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1309 |
| Retacritepoetin alfa-epbx | Epoetin 10000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1308 |
| Retacritepoetin alfa-epbx | Epoetin 3000 [iU]/mL | Injection, SolutionIntravenous, Subcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-1306 |