What is NDC 68083-314?

68083-314 is the product NDC for Oxaliplatin, Oxaliplatin 5 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxaliplatin NDC 68083-314 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-314Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0314Add 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
68083-314-01	6808303140168083031401	1 VIAL, SINGLE-USE in 1 CARTON (68083-314-01) / 40 mL in 1 VIAL, SINGLE-USEMarketed from Nov 6, 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 — 5 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207325
Marketing start: Nov 6, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 68083-314_e90dd0c2-1d2b-42e8-bde6-85718a5b90b9SPL ID e90dd0c2-1d2b-42e8-bde6-85718a5b90b9SPL set ID a6f89dc3-a594-4b5b-8728-272e20c1ecb5RxCUI 1736776, 1736781, 1797528UNII 04ZR38536JUPC 0368083314019, 0368083176013, 0368083177010
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

N468083031401 followed by a unit qualifier and the quantity

Package 68083-0314-01. 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 Aug 24, 2026. 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 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)

About NDC 68083-314

What is NDC 68083-314?: 68083-314 is the product NDC for Oxaliplatin, Oxaliplatin 5 mg/mL injection, 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oxaliplatin NDCs
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

All 40 Oxaliplatin NDCs

Other NDCs under ANDA 207325

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

FDA NDC Directory listings under ANDA 207325
Product	Strength	Form · route	Labeler	Product NDC
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-176
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-177
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-101
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-149
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC.	72266-161
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC.	72266-162
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	NorthStar Rx LLC	72603-101
Oxaliplatin	Oxaliplatin 5 mg/mL	Injection, SolutionIntravenous	NorthStar Rx LLC	72603-301