Prescription drug · ANDA
Oxaliplatin NDC 68001-468
Oxaliplatin 5 mg/mL · Injection, Solution · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-468-36 | 68001046836 | 1 VIAL in 1 CARTON (68001-468-36) / 10 mL in 1 VIALMarketed from Dec 9, 2020 | |
| 68001-468-37 | 68001046837 | 1 VIAL in 1 CARTON (68001-468-37) / 20 mL in 1 VIALMarketed from Dec 9, 2020 |
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
- Route
- Intravenous
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204368
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 68001-468_2ee49254-54a3-0865-e063-6294a90a2974SPL ID 2ee49254-54a3-0865-e063-6294a90a2974SPL set ID b6083405-9b45-4d2c-e053-2995a90ad9efRxCUI 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
N468001046836followed by a unit qualifier and the quantityPackage 68001-0468-36. 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 Injection USP, 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 Injection USP 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.
Other NDCs under ANDA 204368
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 |
|---|---|---|---|---|
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6287 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6132 |
| Oxaliplatin | Oxaliplatin 50 mg/10mL | Injection, SolutionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0508 |
| Oxaliplatin | Oxaliplatin 100 mg/20mL | Injection, SolutionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0509 |
| Oxaliplatin | Oxaliplatin 200 mg/40mL | Injection, SolutionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0510 |