Cisplatin

Product NDC: 65219-359
11-digit product format: 652190359
Labeler code: 65219
Product ID: 65219-359_a91e4890-e792-422b-92f3-8eb99c31aeb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CISPLATIN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Marketing category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start: 2023-09-01
Substance: CISPLATIN
Active strength: 1 mg/mL
Pharmacologic classes: Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65219-359		I	Inactivated by FDA		2026-08-17
excluded package	package	65219-359	65219-359-50	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c9c59a98-9c44-9141-5aed-28a9bfc56d6e	Product name	4	20250220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65219-359-50	2024-01-30	C162847	48780-1	1030e365-1643-111a-e063-dadaa90a10e2	851e111b-d7c9-4781-849b-3d036e13ce3f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-359-50	Cisplatin	50 mL in 1 VIAL	INJECTION, SOLUTION	50		2
65219-359-50	Cisplatin	1 in 1 CARTON	INJECTION, SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-359-50	ML - Milliliter	65219-359	888dfaa9-4613-40c7-8416-b4802a478674	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-359	CISPLATIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2	Current NDC, 2 package rows	20240316_851e111b-d7c9-4781-849b-3d036e13ce3f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q20Q21Q62J	CISPLATIN	15663-27-1	CISPLATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309311	CISplatin 1 MG/ML Injectable Solution	PSN	851e111b-d7c9-4781-849b-3d036e13ce3f	2
309311	cisplatin 1 MG/ML Injectable Solution	SCD	851e111b-d7c9-4781-849b-3d036e13ce3f	2
309311	cisplatin 100 MG per 100 ML Injectable Solution	SY	851e111b-d7c9-4781-849b-3d036e13ce3f	2
309311	cisplatin 50 MG per 50 ML Injectable Solution	SY	851e111b-d7c9-4781-849b-3d036e13ce3f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65219-359-50	65219035950	50 mL in 1 VIAL	50 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cisplatin - Fresenius Kabi USA, LLC \| Fresenius Kabi Oncology Limited	Fresenius Kabi USA, LLC \| Fresenius Kabi Oncology Limited	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	2