Prescription drug · ANDA
Irinotecan Hydrochloride NDC 61703-349
Irinotecan hydrochloride 20 mg/mL · Injection, Solution · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61703-349-09 | 6170303490961703034909 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-09) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 27, 2008 | |
| 61703-349-16 | 6170303491661703034916 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-16) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 27, 2008 | |
| 61703-349-36 | 6170303493661703034936 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-36) / 25 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 27, 2008 |
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, Solution
- Route
- Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 61703
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077915
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 61703-349_9c52ca8e-58dd-4117-a5bc-f277e79abb19SPL ID 9c52ca8e-58dd-4117-a5bc-f277e79abb19SPL set ID 5c527c2e-9062-4afe-dbbb-f650db3a340fRxCUI 1726319, 1726324, 1726492UNII 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.
- NDC on a medical claim
N461703034909followed by a unit qualifier and the quantityPackage 61703-0349-09. 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, USP 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, 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: • 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 re…
Excerpt only. Read the full label for complete information.
About NDC 61703-349
- What is NDC 61703-349?
- 61703-349 is the product NDC for Irinotecan Hydrochloride, Irinotecan hydrochloride 20 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 3 package NDCs, 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?
- Hospira, Inc., NDC labeler code 61703. 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.
Related NDCs: other Irinotecan Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |