Cisplatin NDC 25021-253

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0253Add 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
25021-253-50	25021025350	1 VIAL in 1 CARTON (25021-253-50) / 50 mL in 1 VIALMarketed from Jul 1, 2023
25021-253-51	25021025351	1 VIAL in 1 CARTON (25021-253-51) / 100 mL in 1 VIALMarketed from Jul 1, 2023

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: Sagent Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207323
Marketing start: Jul 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Platinum-containing Compounds (EXT)
Identifiers: Product ID 25021-253_bf489cd3-17a3-4398-ba7e-2cb9e87b9c13SPL ID bf489cd3-17a3-4398-ba7e-2cb9e87b9c13SPL set ID 00396546-6a80-4b9f-a5f8-c22c1d1bb173RxCUI 309311UNII Q20Q21Q62J
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

N425021025350 followed by a unit qualifier and the quantity

Package 25021-0253-50. 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 Jan 20, 2024. 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 radio therapeutic 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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	FOSUN PHARMA USA INC	72266-252
Cisplatin	Cisplatin 1 mg/mL	Injection, SolutionIntravenous	FOSUN PHARMA USA INC	72266-253
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	Gland Pharma Limited	68083-163