Prescription drug · NDA
Camptosar (irinotecan hydrochloride) NDC 0009-0082
Irinotecan hydrochloride 20 mg/mL · Injection, Solution · Intravenous · Pharmacia & Upjohn Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0009-0082-02 | 00009008202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 24, 2024 |
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)
- Camptosar
- Generic name (nonproprietary)
- irinotecan hydrochloride
- Active ingredients
- Irinotecan hydrochloride — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020571
- Marketing start
- Listing expires
- Other FDA classes
- Topoisomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 0009-0082_6f05fe24-191a-4273-ad62-4ab6b5324062SPL ID 6f05fe24-191a-4273-ad62-4ab6b5324062SPL set ID e518dfc6-7e93-4fee-a66c-51e1ab71c056RxCUI 1726319, 1726321, 1726324, 1726325, 1726333, 1726335UNII 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
N400009008202followed by a unit qualifier and the quantityPackage 00009-0082-02. 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)
• CAMPTOSAR 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. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR 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…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020571
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 |
|---|---|---|---|---|
| Camptosaririnotecan hydrochloride | Irinotecan hydrochloride 20 mg/mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-0112 |
| Camptosaririnotecan hydrochloride | Irinotecan hydrochloride 20 mg/mL | Injection, SolutionIntravenous | Pharmacia & Upjohn Company LLC | 0009-7529 |