Irinotecan hydrochloride NDC 68083-382

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-382Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0382Add 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
68083-382-01	68083038201	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-382-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 18, 2019

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 hydrochloride
Generic name (nonproprietary): irinotecan hydrochloride
Active ingredients: Irinotecan hydrochloride — 20 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212993
Marketing start: Nov 18, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 68083-382_a1ced9af-9117-485c-925d-47f7266bc9dfSPL ID a1ced9af-9117-485c-925d-47f7266bc9dfSPL set ID de634e80-328a-4473-b395-0172683a2411RxCUI 1726319, 1726324UNII 042LAQ1IISUPC 0336808338107, 0368083382018
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

N468083038201 followed by a unit qualifier and the quantity

Package 68083-0382-01. 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 Mar 3, 2022. 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 diseas…

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 hydrochloide	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-480
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 hydrochloide	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Xiromed LLC	70700-169
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Xiromed LLC	70700-170