What is NDC 39822-0255?

39822-0255 is the product NDC for Cyclophosphamide, Cyclophosphamide 1 g/50mL injection, powder, lyophilized, for solution, listed with the FDA by XGen Pharmaceuticals DJB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. 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 39822-0255 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)39822-0255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39822-0255Add 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
39822-0255-1	39822025501	1 VIAL, SINGLE-DOSE in 1 CARTON (39822-0255-1) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 19, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1 g/50mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous, Oral
Labeler: XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211757
Marketing start: Dec 19, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 39822-0255_29b88d00-eeea-7282-e063-6294a90a4024SPL ID 29b88d00-eeea-7282-e063-6294a90a4024SPL set ID 02e64046-687d-449e-e063-6294a90a6c32RxCUI 1734917, 1734919, 1734921UNII 8N3DW7272PUPC 0339822025510, 0339822025015, 0339822026012

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

N439822025501 followed by a unit qualifier and the quantity

Package 39822-0255-01. 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 Dec 20, 2024.

Indications (excerpt from the label)

Cyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 39822-0255

What is NDC 39822-0255?: 39822-0255 is the product NDC for Cyclophosphamide, Cyclophosphamide 1 g/50mL injection, powder, lyophilized, for solution, listed with the FDA by XGen Pharmaceuticals DJB, Inc.. 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?: XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. 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 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-695	68001-0695-32
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-694	68001-0694-27
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-696	68001-0696-32
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-206	83634-0206-51
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-205	83634-0205-50
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 211757

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

FDA NDC Directory listings under ANDA 211757
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, Lyophilized, For solutionIntravenous, Oral	XGen Pharmaceuticals DJB, Inc.	39822-0250
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, Lyophilized, For solutionIntravenous, Oral	XGen Pharmaceuticals DJB, Inc.	39822-0260