What is NDC 65219-135?

65219-135 is the product NDC for Cyclophosphamide, Cyclophosphamide 500 mg/25mL injection, powder, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Cyclophosphamide?

83 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclophosphamide NDC 65219-135 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-135Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0135Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-135-20	6521901352065219013520	1 VIAL, SINGLE-DOSE in 1 CARTON (65219-135-20) / 25 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 17, 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): Cyclophosphamide
Generic name (nonproprietary): cyclophosphamide
Active ingredients: Cyclophosphamide — 500 mg/25mL
Dosage form: Injection, Powder, For solution
Route: Intravenous, Oral
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204555
Marketing start: Nov 17, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 65219-135_fadfc813-11a5-415a-9d70-06c579e7619cSPL ID fadfc813-11a5-415a-9d70-06c579e7619cSPL set ID 31986d36-a1bf-4903-93a4-ce7386241ba1RxCUI 1734917, 1734919, 1734921UNII 8N3DW7272P

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.

How CPT relates to drug billing

NDC on a medical claim

N465219013520 followed by a unit qualifier and the quantity

Package 65219-0135-20. 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 Oct 9, 2024.

Indications (excerpt from the label)

Cyclophosphamide is an alkylating drug indicated for treatment of: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been establ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-135

What is NDC 65219-135?: 65219-135 is the product NDC for Cyclophosphamide, Cyclophosphamide 500 mg/25mL injection, powder, for 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?: Cyclophosphamide.
What is the active ingredient?: Cyclophosphamide.
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 Cyclophosphamide?: 83 other product NDCs are listed under this name. See all Cyclophosphamide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyclophosphamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclophosphamide	Cyclophosphamide 25 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2013	70301-2013-01
Cyclophosphamide	Cyclophosphamide 50 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2015	70301-2015-01
Cyclophosphamide	Cyclophosphamide 200 mg/mL	InjectionIntravenous	Nexus Pharmaceuticals, LLC	14789-125	14789-0125-05
Cyclophosphamide	Cyclophosphamide 200 mg/mL	InjectionIntravenous	Nexus Pharmaceuticals, LLC	14789-126	14789-0126-05
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-694	68001-0694-27
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-695	68001-0695-32
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-696	68001-0696-32
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-205	83634-0205-50
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-206	83634-0206-51
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-207	83634-0207-51

All 84 Cyclophosphamide NDCs

Other NDCs under ANDA 204555

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204555
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	Sandoz Inc.	0781-3233
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	Sandoz Inc.	0781-3244
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	Sandoz Inc.	0781-3255
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	NorthStar Rx LLC	16714-857
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	NorthStar Rx LLC	16714-858
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	NorthStar Rx LLC	16714-859
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	Fresenius Kabi USA, LLC	65219-131
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	Fresenius Kabi USA, LLC	65219-133