What is NDC 83831-116?

83831-116 is the product NDC for Cyclophosphamide, Cyclophosphamide 500 mg/mL injection, listed with the FDA by Avyxa Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Avyxa Pharma, LLC, NDC labeler code 83831. 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 83831-116 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83831-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83831-0116Add 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
83831-116-01	8383101160183831011601	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-116-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed 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): Cyclophosphamide
Generic name (nonproprietary): cyclophosphamide
Active ingredients: Cyclophosphamide — 500 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Avyxa Pharma, LLCNDC labeler code 83831
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210852
Marketing start: Aug 1, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 83831-116_5fc45658-c2d9-41de-821f-ff6f40a469ddSPL ID 5fc45658-c2d9-41de-821f-ff6f40a469ddSPL set ID 6f593585-e0dd-48bc-bd2b-c6c787e0b98cRxCUI 2644738, 2644751, 2644824UNII 8N3DW7272PUPC 0383831118046, 0383831117025, 0383831116011

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

N483831011601 followed by a unit qualifier and the quantity

Package 83831-0116-01. 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 Jul 26, 2024.

Indications (excerpt from the label)

Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) aden…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83831-116

What is NDC 83831-116?: 83831-116 is the product NDC for Cyclophosphamide, Cyclophosphamide 500 mg/mL injection, listed with the FDA by Avyxa Pharma, 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?: Avyxa Pharma, LLC, NDC labeler code 83831. 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 NDA 210852

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

FDA NDC Directory listings under NDA 210852
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 1 g/2mL	InjectionIntravenous	Avyxa Pharma, LLC	83831-117
Cyclophosphamide	Cyclophosphamide 2 g/4mL	InjectionIntravenous	Avyxa Pharma, LLC	83831-118
Frindovyxcyclophosphamide	Cyclophosphamide 500 mg/mL	InjectionIntravenous	AVYXA Pharma, LLC	83831-119
Frindovyxcyclophosphamide	Cyclophosphamide 1 g/2mL	InjectionIntravenous	AVYXA Pharma, LLC	83831-120
Frindovyxcyclophosphamide	Cyclophosphamide 2 g/4mL	InjectionIntravenous	AVYXA Pharma, LLC	83831-121