Ifosfamide NDC 0143-9531

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9531Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9531Add 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
0143-9531-01	00143953101	1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIALMarketed from Jun 10, 2017

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): Ifosfamide
Generic name (nonproprietary): ifosfamide
Active ingredients: Ifosfamide — 50 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076619
Marketing start: Jun 10, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 0143-9531_517c3bf6-41f5-4199-a17e-1f46b120cb1eSPL ID 517c3bf6-41f5-4199-a17e-1f46b120cb1eSPL set ID c90ab05f-8fe5-437e-a1c0-8b11ef63291eRxCUI 1791597, 1791599UNII UM20QQM95Y
Pharmacologic class: Alkylating Drug

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

N400143953101 followed by a unit qualifier and the quantity

Package 00143-9531-01. 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 Jun 1, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. Ifosfamide Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076619

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

FDA NDC Directory listings under ANDA 076619
Product	Strength	Form · route	Labeler	Product NDC
Ifosfamide	Ifosfamide 50 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9530