Irinotecan Hydrochloride NDC 60505-6128

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-6128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-6128Add 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
60505-6128-0	60505612800	1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) / 2 mL in 1 VIAL, SINGLE-USEMarketed from Nov 30, 2017
60505-6128-1	60505612801	1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Nov 30, 2017

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): Irinotecan Hydrochloride
Generic name (nonproprietary): irinotecan hydrochloride
Active ingredients: Irinotecan hydrochloride — 20 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203380
Marketing start: Nov 30, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 60505-6128_d2676b1a-30fb-456b-bb51-fb76fb64cf2dSPL ID d2676b1a-30fb-456b-bb51-fb76fb64cf2dSPL set ID 85ed6019-f462-4abe-a89e-ad991623c86dRxCUI 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

N460505612800 followed by a unit qualifier and the quantity

Package 60505-6128-00. 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 28, 2024. 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 203380

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

FDA NDC Directory listings under ANDA 203380
Product	Strength	Form · route	Labeler	Product NDC
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Apotex Corp.	60505-6272
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0512
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0511
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0513