Prescription drug · ANDA
Oxaliplatin NDC 67184-0509
Oxaliplatin 100 mg/20mL · Injection, Solution · Intravenous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0509-1 | 67184050901 | 1 VIAL, SINGLE-USE in 1 CARTON (67184-0509-1) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Jun 7, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/20mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- 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 67184-0509_e78605b3-b28b-4634-9a58-d4bda67832baSPL ID e78605b3-b28b-4634-9a58-d4bda67832baSPL set ID 33d4f4b4-bb4e-46af-9e89-df20154436d0RxCUI 1736776, 1736781, 1797528UNII 04ZR38536JUPC 0367184050918, 0367184051014, 0367184050819
- 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
N467184050901followed by a unit qualifier and the quantityPackage 67184-0509-01. 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 | BluePoint Laboratories | 68001-468 |
| 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 200 mg/40mL | Injection, SolutionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0510 |