NDC codes

FDA NDC Directory
Product NDC (as listed)70700-170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0170Add 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 NDC11-digit (billing)PackageCopy
70700-170-2270700017022707000170221 VIAL, SINGLE-DOSE in 1 CARTON (70700-170-22) / 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
Xiromed LLCNDC labeler code 70700
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212993
Marketing start
Listing expires
Other FDA classes
Topoisomerase Inhibitors (Mechanism)
Identifiers
Product ID 70700-170_4b364426-00fb-0ef1-e063-6394a90aaba6SPL ID 4b364426-00fb-0ef1-e063-6394a90aaba6SPL set ID b26e5d27-dba5-7538-9e7b-48b358998cbbRxCUI 1726319, 1726324UNII 042LAQ1IISUPC 0370700170229, 0370700169223
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

N470700017022 followed by a unit qualifier and the quantity

Package 70700-0170-22. 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 . 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 has …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70700-170

What is NDC 70700-170?
70700-170 is the product NDC for Irinotecan hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, listed with the FDA by Xiromed LLC. 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?
Xiromed LLC, NDC labeler code 70700. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousApotex Corp.60505-627260505-6272-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousEugia US LLC55150-35555150-0355-01
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousNorthstar Rx LLC16714-02716714-0027-01
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousNorthstar Rx LLC16714-13116714-0131-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousEugia US LLC55150-35255150-0352-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousEugia US LLC55150-35355150-0353-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousEugia US LLC55150-35455150-0354-01
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousGland Pharma Limited68083-38268083-0382-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousApotex Corp.60505-612860505-6128-0060505-6128-01
Irinotecan HydrochlorideIrinotecan hydrochloride 20 mg/mLInjection, SolutionIntravenousQilu Pharmaceutical Co., Ltd.67184-051167184-0511-01

All 20 Irinotecan hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Irinotecan hydrochloideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousBluePoint Laboratories68001-480
Irinotecan hydrochloideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousGland Pharma Limited68083-381
Irinotecan hydrochloideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousXiromed LLC70700-169
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousNorthstar Rx LLC16714-027
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousNorthstar Rx LLC16714-131
Irinotecan hydrochlorideIrinotecan hydrochloride 20 mg/mLInjectionIntravenousGland Pharma Limited68083-382

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