Irinotecan hydrochloide NDC 68001-480

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0480Add 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
68001-480-22	68001048022	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 14, 2020
68001-480-35	68001048035	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 14, 2020

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): Irinotecan hydrochloide
Generic name (nonproprietary): irinotecan hydrochloide
Active ingredients: Irinotecan hydrochloride — 20 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212993
Marketing start: Dec 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 68001-480_598e6850-4a95-1b97-e063-6294a90aef64SPL ID 598e6850-4a95-1b97-e063-6294a90aef64SPL set ID b66dbd6d-6ccb-ce9d-e053-2995a90a4c3cRxCUI 1726319, 1726324UNII 042LAQ1IIS
Pharmacologic class: Topoisomerase Inhibitor

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

N468001048022 followed by a unit qualifier and the quantity

Package 68001-0480-22. 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 Aug 26, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1) • Patients with metastatic carcinoma of the colon or rectum whose disease ha…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212993

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

FDA NDC Directory listings under ANDA 212993
Product	Strength	Form · route	Labeler	Product NDC
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Northstar Rx LLC	16714-027
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Northstar Rx LLC	16714-131
Irinotecan hydrochloide	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-381
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-382
Irinotecan hydrochloide	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Xiromed LLC	70700-169
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Xiromed LLC	70700-170