What is NDC 68083-163?

68083-163 is the product NDC for Cisplatin, Cisplatin 1 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 Cisplatin?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cisplatin NDC 68083-163 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0163Add 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
68083-163-01	6808301630168083016301	1 VIAL in 1 CARTON (68083-163-01) / 100 mL in 1 VIALMarketed from Apr 3, 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): Cisplatin
Generic name (nonproprietary): cisplatin
Active ingredients: Cisplatin — 1 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 207323
Marketing start: Apr 3, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 68083-163_89007399-3c34-40d2-8068-a0b8e09cbef8SPL ID 89007399-3c34-40d2-8068-a0b8e09cbef8SPL set ID a32820f7-9ff6-4c13-a96a-4483a943fe82RxCUI 309311UNII Q20Q21Q62JUPC 0368083162016, 0368083163013
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

N468083016301 followed by a unit qualifier and the quantity

Package 68083-0163-01. 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 Sep 26, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of cisplatin and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-163

What is NDC 68083-163?: 68083-163 is the product NDC for Cisplatin, Cisplatin 1 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?: Cisplatin.
What is the active ingredient?: Cisplatin.
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 Cisplatin?: 18 other product NDCs are listed under this name. See all Cisplatin 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 Cisplatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
CISplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	Apotex Corp.	60505-6279	60505-6279-00
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-608	68001-0608-24
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-609	68001-0609-33
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC	72266-252	72266-0252-01
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC	72266-253	72266-0253-01
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-253	25021-0253-5025021-0253-51
Cisplatin	Cisplatin 50 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	WG Critical Care, LLC	44567-530	44567-0530-01
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-162	68083-0162-01
Cisplatin	Cisplatin 1 mg/mL	InjectionIntravenous	Accord Healthcare Inc.	16729-288	16729-0288-1116729-0288-38
Cisplatin	Cisplatin 1 mg/mL	InjectionIntravenous	BluePoint Laboratories	68001-283	68001-0283-2768001-0283-32

All 19 Cisplatin NDCs

Other NDCs under ANDA 207323

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

FDA NDC Directory listings under ANDA 207323
Product	Strength	Form · route	Labeler	Product NDC
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-253
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-608
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-609
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-162
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC	72266-252
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC	72266-253