Prescription drug · ANDA
Plerixafor NDC 25021-416
Plerixafor 20 mg/mL · Injection, Solution · Subcutaneous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-416-01 | 25021041601 | 1 VIAL in 1 CARTON (25021-416-01) / 1.2 mL in 1 VIALMarketed from Aug 1, 2024 |
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)
- Plerixafor
- Generic name (nonproprietary)
- plerixafor
- Active ingredients
- Plerixafor — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206644
- Marketing start
- Listing expires
- Other FDA classes
- Increased Hematopoietic Stem Cell Mobilization (Physiologic effect)
- Identifiers
- Product ID 25021-416_69c3fb68-4dfb-43db-bc59-421e4b3dfa0cSPL ID 69c3fb68-4dfb-43db-bc59-421e4b3dfa0cSPL set ID 711b7bf7-4385-4365-b12a-ede6c3f1ed45RxCUI 828700UNII S915P5499N
- Pharmacologic class
- Hematopoietic Stem Cell Mobilizer
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
N425021041601followed by a unit qualifier and the quantityPackage 25021-0416-01. 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 .
Indications (excerpt from the label)
Plerixafor Injection is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Plerixafor Injection, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206644
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 |
|---|---|---|---|---|
| Plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Gland Pharma Limited | 68083-155 |