What is NDC 0143-9701?

0143-9701 is the product NDC for Irinotecan Hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 0143-9701

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9701Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9701Add 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
0143-9701-01	0014397010100143970101	5 mL in 1 VIAL, GLASS (0143-9701-01)Marketed from Dec 20, 2010

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): Irinotecan Hydrochloride
Generic name (nonproprietary): irinotecan hydrochloride
Active ingredients: Irinotecan hydrochloride — 20 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091032
Marketing start: Dec 20, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Topoisomerase Inhibitors (Mechanism)
Identifiers: Product ID 0143-9701_204eb37a-642f-4321-9466-414c32a6bbceSPL ID 204eb37a-642f-4321-9466-414c32a6bbceSPL set ID be716692-6b4f-47b6-83d1-01665861626bRxCUI 1726319, 1726324UNII 042LAQ1IISUPC 0301439701019
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

N400143970101 followed by a unit qualifier and the quantity

Package 00143-9701-01. 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 23, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Irinotecan Hydrochloride Injection, USP 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, USP is a topoisomerase inhibitor indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9701

What is NDC 0143-9701?: 0143-9701 is the product NDC for Irinotecan Hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 091032

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

FDA NDC Directory listings under ANDA 091032
Product	Strength	Form · route	Labeler	Product NDC
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9583
Irinotecan Hydrochloride	Irinotecan hydrochloride 20 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9702