Oxaliplatin NDC 0781-9317

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-9317Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-9317Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0781-9317-80	00781931780	1 VIAL, SINGLE-USE in 1 CARTON (0781-9317-80) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Jul 1, 2016

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): Oxaliplatin
Generic name (nonproprietary): oxaliplatin
Active ingredients: Oxaliplatin — 5 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078817
Marketing start: Jul 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 0781-9317_ac83b4cd-5026-4dd5-b733-125d28ba3c95SPL ID ac83b4cd-5026-4dd5-b733-125d28ba3c95SPL set ID 86f6c19d-30d1-42e3-8d46-5e3f45776e85RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N400781931780 followed by a unit qualifier and the quantity

Package 00781-9317-80. 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 Jul 25, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Oxaliplatin injection, 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 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078817

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078817
Product	Strength	Form · route	Labeler	Product NDC
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3315
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3317
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Sandoz Inc	0781-9315
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	43066-014
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	43066-018