Cyclophosphamide NDC 0338-9777

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-9777Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-9777Add 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
0338-9777-01	00338977701	1 VIAL in 1 CARTON (0338-9777-01) / 2.5 mL in 1 VIALMarketed from Aug 1, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 injection, solution
Active ingredients: Cyclophosphamide — 200 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Baxter Healthcare Company
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217651
Marketing start: Aug 1, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 0338-9777_5c81399c-bacb-48ec-8985-836412a07a6dSPL ID 5c81399c-bacb-48ec-8985-836412a07a6dSPL set ID 34dbffee-80e0-49c3-90e8-95713a0b7fbeRxCUI 2386859UNII 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

N400338977701 followed by a unit qualifier and the quantity

Package 00338-9777-01. 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 Apr 10, 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 di…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 217651

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

FDA NDC Directory listings under NDA 217651
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamidecyclophosphamide injection, solution	Cyclophosphamide 200 mg/mL	InjectionIntravenous	Baxter Healthcare Company	0338-9779