Cyclophosphamide NDC 16714-858

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-858Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0858Add 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
16714-858-01	16714085801	1 VIAL, SINGLE-DOSE in 1 CARTON (16714-858-01) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 8, 2019

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 — 2 g/100mL
Dosage form: Injection, Powder, For solution
Route: Intravenous, Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204555
Marketing start: Jan 8, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 16714-858_27e82150-4ad3-5be6-e063-6394a90a0e3fSPL ID 27e82150-4ad3-5be6-e063-6394a90a0e3fSPL set ID 76f057be-e3da-0a89-e053-2a91aa0a8438RxCUI 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

N416714085801 followed by a unit qualifier and the quantity

Package 16714-0858-01. 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 Nov 20, 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)

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 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
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	Fresenius Kabi USA, LLC	65219-135
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	NorthStar Rx LLC	16714-857
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	NorthStar Rx LLC	16714-859
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