Prescription drug · ANDA
Oxaliplatin NDC 68083-170
Oxaliplatin 50 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-170-01 | 6808301700168083017001 | 10 mL in 1 VIAL (68083-170-01)Marketed from May 29, 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)
- Oxaliplatin
- Generic name (nonproprietary)
- oxaliplatin
- Active ingredients
- Oxaliplatin — 50 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207385
- Marketing start
- Listing expires
- Other FDA classes
- Platinum-containing Compounds (EXT)
- Identifiers
- Product ID 68083-170_0d039035-85d1-40d4-8ee6-540026ab7a5cSPL ID 0d039035-85d1-40d4-8ee6-540026ab7a5cSPL set ID d6178bc6-9dae-413f-8f47-de75d576c5b8RxCUI 1736784, 1736786UNII 04ZR38536JUPC 0368083171018, 0368083170011
- 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
N468083017001followed by a unit qualifier and the quantityPackage 68083-0170-01. 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 for injection USP, used in combination with infusional 5-fluorouracil/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 for injection USP is a platinum-based drug used in combination with infusional 5-fluorouracil/leucovorin, which 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. (1)
Excerpt only. Read the full label for complete information.
About NDC 68083-170
- What is NDC 68083-170?
- 68083-170 is the product NDC for Oxaliplatin, Oxaliplatin 50 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxaliplatin.
- What is the active ingredient?
- Oxaliplatin.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxaliplatin?
- 39 other product NDCs are listed under this name. See all Oxaliplatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxaliplatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-336 | 42677-0336-10 |
| oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Shandong New Time Pharmaceutical Co., Ltd. | 42677-337 | 42677-0337-10 |
| Oxaliplatin | Oxaliplatin 50 mg/10mL | Injection, Solution, ConcentrateIntravenous | Camber Pharmaceuticals, Inc. | 31722-357 | 31722-0357-10 |
| Oxaliplatin | Oxaliplatin 100 mg/20mL | Injection, Solution, ConcentrateIntravenous | Camber Pharmaceuticals, Inc. | 31722-358 | 31722-0358-20 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Apotex Corp. | 60505-6287 | 60505-6287-0260505-6287-04 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-171 | 71288-0171-11 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-172 | 71288-0172-21 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Northstar Rx LLC | 72603-320 | 72603-0320-01 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | Northstar Rx LLC | 72603-420 | 72603-0420-01 |
| Oxaliplatin | Oxaliplatin 5 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-468 | 68001-0468-3668001-0468-37 |
Other NDCs under ANDA 207385
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 100 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-171 |