Cyclophosphamide NDC 0054-0383

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0383Add 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
0054-0383-25	00054038325	100 CAPSULE in 1 BOTTLE (0054-0383-25)Marketed from Sep 16, 2013

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
Active ingredients: Cyclophosphamide — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203856
Marketing start: Sep 16, 2013
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0383_35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4SPL ID 35c0ebb6-6127-4e3a-9846-4ad17f7d5cd4SPL set ID 8135b917-882f-4b4c-99b7-fa8ea54af4bfRxCUI 1437968, 1437969UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054038325 followed by a unit qualifier and the quantity

Package 00054-0383-25. 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 19, 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 in pediatric 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 203856

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

FDA NDC Directory listings under NDA 203856
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 25 mg/1	CapsuleOral	Hikma Pharmaceuticals USA Inc.	0054-0382