Prescription drug · ANDA
Irinotecan Hydrochloride NDC 50742-401
Irinotecan hydrochloride 40 mg/2mL · Injection · Intravenous · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-401-02 | 50742040102 | 1 VIAL, GLASS in 1 CARTON (50742-401-02) / 2 mL in 1 VIAL, GLASSMarketed from Jun 5, 2017 |
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 — 40 mg/2mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206935
- Marketing start
- Marketing end
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 50742-401_b3cfa0f6-fbdc-4f19-9dac-beaf398603d8SPL ID b3cfa0f6-fbdc-4f19-9dac-beaf398603d8SPL set ID d04f2471-3085-4fc8-a657-bb3918d48e6eRxCUI 1726319, 1726324UNII 042LAQ1IISUPC 0350742402052, 0350742401024
- 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
N450742040102followed by a unit qualifier and the quantityPackage 50742-0401-02. 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 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 recurred or progressed following initial fluorouracil-based therapy. ( 1 ) 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 diseas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206935
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Irinotecan Hydrochloride | Irinotecan hydrochloride 100 mg/5mL | InjectionIntravenous | Ingenus Pharmaceuticals, LLC | 50742-402 |