Prescription drug · ANDA
Oxaliplatin NDC 61703-363
Oxaliplatin 5 mg/mL · Injection, Solution, Concentrate · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61703-363-18 | 61703036318 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-18) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 10, 2009 | |
| 61703-363-22 | 61703036322 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-363-22) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 10, 2009 |
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)
- Oxaliplatin
- Generic name (nonproprietary)
- oxaliplatin
- Active ingredients
- Oxaliplatin — 5 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078813
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 61703-363_4edbffab-0628-4c35-ac6a-76a629f3c9ddSPL ID 4edbffab-0628-4c35-ac6a-76a629f3c9ddSPL set ID e51a62ba-d163-4c57-835c-8c86cf097e40RxCUI 1736776, 1736781UNII 04ZR38536J
- Pharmacologic class
- Platinum-based Drug
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
N461703036318followed by a unit qualifier and the quantityPackage 61703-0363-18. 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)
Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for: • adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. • treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: • adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) • treatment of advanced colorectal cancer. ( 1 )
Excerpt only. Read the full label for complete information.