Prescription drug · NDA AUTHORIZED GENERIC
Plerixafor NDC 65219-284
Plerixafor 24 mg/1.2mL · Injection, Solution · Subcutaneous · Fresenius Kabi Usa, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-284-12 | 65219028412 | 1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USEMarketed from Jun 22, 2023 |
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 — 24 mg/1.2mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Fresenius Kabi Usa, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022311
- Marketing start
- Listing expires
- Other FDA classes
- Increased Hematopoietic Stem Cell Mobilization (Physiologic effect)
- Identifiers
- Product ID 65219-284_ba468eca-fb47-497b-8aed-a1576249ea6aSPL ID ba468eca-fb47-497b-8aed-a1576249ea6aSPL set ID 5d670cb4-163e-498c-b5fa-c193ea9d55c0RxCUI 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
N465219028412followed by a unit qualifier and the quantityPackage 65219-0284-12. 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 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, 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.
About NDC 65219-284
- What is NDC 65219-284?
- 65219-284 is the product NDC for Plerixafor, Plerixafor 24 mg/1.2mL injection, solution, listed with the FDA by Fresenius Kabi Usa, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Plerixafor.
- What is the active ingredient?
- Plerixafor.
- Who is the labeler?
- Fresenius Kabi Usa, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Plerixafor?
- 11 other product NDCs are listed under this name. See all Plerixafor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Plerixafor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Camber Pharmaceuticals, Inc. | 31722-373 | 31722-0373-31 |
| Plerixafor | Plerixafor 20 mg/mL | Injection, SolutionSubcutaneous | Sagent Pharmaceuticals | 25021-416 | 25021-0416-01 |
| Plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Gland Pharma Limited | 68083-155 | 68083-0155-01 |
| Plerixafor | Plerixafor 24 mg/1.2mL | SolutionSubcutaneous | Dr. Reddy's Laboratories Inc | 43598-308 | 43598-0308-23 |
| Plerixafor | Plerixafor 24 mg/1.2mL | InjectionSubcutaneous | Zydus Pharmaceuticals USA Inc. | 70710-1208 | 70710-1208-01 |
| Plerixafor | Plerixafor 24 mg/1.2mL | InjectionSubcutaneous | Zydus Lifesciences Limited | 70771-1776 | 70771-1776-01 |
| plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Amneal Pharmaceuticals LLC | 70121-1694 | 70121-1694-02 |
| Plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Bryant Ranch Prepack | 72162-2642 | 72162-2642-02 |
| Plerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Novadoz Pharmaceuticals LLC | 72205-249 | 72205-0249-01 |
| Plerixafor | Plerixafor 24 mg/1.2mL | SolutionSubcutaneous | Eugia US LLC | 55150-356 | 55150-0356-01 |
Other NDCs under NDA 022311
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 |
|---|---|---|---|---|
| Mozobilplerixafor | Plerixafor 24 mg/1.2mL | Injection, SolutionSubcutaneous | Sanofi-Aventis U.S. LLC | 0024-5862 |