What is NDC 67184-0512?

67184-0512 is the product NDC for Irinotecan Hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Irinotecan Hydrochloride?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Irinotecan Hydrochloride NDC 67184-0512

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0512Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0512Add 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
67184-0512-1	6718405120167184051201	1 VIAL, SINGLE-USE in 1 CARTON (67184-0512-1) / 5 mL in 1 VIAL, SINGLE-USEMarketed from May 3, 2016

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: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203380
Marketing start: May 3, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 67184-0512_5faaf9ca-ed20-4ebf-9e7f-1d3a0ca60056SPL ID 5faaf9ca-ed20-4ebf-9e7f-1d3a0ca60056SPL set ID afcdde49-ec0c-4c56-a1af-2917185b1a08RxCUI 1726319, 1726324, 1726333UNII 042LAQ1IISUPC 0367184051311
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

N467184051201 followed by a unit qualifier and the quantity

Package 67184-0512-01. 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 10, 2021. 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)

About NDC 67184-0512

What is NDC 67184-0512?: 67184-0512 is the product NDC for Irinotecan Hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, solution, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Irinotecan Hydrochloride.
What is the active ingredient?: Irinotecan hydrochloride.
Who is the labeler?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Irinotecan Hydrochloride?: 19 other product NDCs are listed under this name. See all Irinotecan Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Irinotecan Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Apotex Corp.	60505-6272	60505-6272-01
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-355	55150-0355-01
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Northstar Rx LLC	16714-027	16714-0027-01
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Northstar Rx LLC	16714-131	16714-0131-01
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-352	55150-0352-01
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-353	55150-0353-01
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Eugia US LLC	55150-354	55150-0354-01
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Gland Pharma Limited	68083-382	68083-0382-01
Irinotecan hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Xiromed LLC	70700-170	70700-0170-22
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Apotex Corp.	60505-6128	60505-6128-0060505-6128-01

All 20 Irinotecan Hydrochloride NDCs

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.	60505-6128
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.	67184-0511
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	Injection, SolutionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0513