CISplatin

Product NDC: 44567-511
11-digit product format: 445670511
Labeler code: 44567
Product ID: 44567-511_dd45d777-d4c1-40ee-b4f0-c9e001a15a8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CISplatin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: WG Critical Care, LLC
Application: NDA018057
Marketing category: NDA
Marketing start: 2015-04-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018057-001	PLATINOL	CISPLATIN	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982
N018057-002	CISPLATIN	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982
N018057-003	PLATINOL-AQ	CISPLATIN	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18
N018057-004	CISPLATIN	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018057-004	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018057-001	PLATINOL	10MG/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018057-002	CISPLATIN	50MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018057-003	PLATINOL-AQ	0.5MG/ML	INJECTABLE / INJECTION		RLD	1984-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018057-004	CISPLATIN	1MG/ML	INJECTABLE / INJECTION	AP	RLD	1988-11-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018057-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018057-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018057-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018057-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018057-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018057-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018057-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018057-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018057-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018057-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018057-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018057-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018057-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018057-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018057-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018057-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018057-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018057-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018057-004	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018057-004	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018057-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018057-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018057-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018057-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018057-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018057-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018057-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018057-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018057-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018057-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018057-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018057-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018057-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018057-004	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018057-004	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018057-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018057-004	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018057-004	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018057-004	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018057-004	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CISplatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CISPLATIN	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q20Q21Q62J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309311	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2bf8d2fb-80c8-401d-8e9b-d58463f5e954	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44567-511-01	CISplatin	200 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	200		5
44567-511-01	CISplatin	1 in 1 CARTON	INJECTION, SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44567-511-01	ML - Milliliter	44567-511	b9d4c685-01a4-4ceb-aa8a-a26639889aca	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cisplatin	ACTIVE INGREDIENT	Q20Q21Q62J	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3
cisplatin	ACTIVE MOIETY	Q20Q21Q62J	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44567-511	CISPLATIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20211003_2bf8d2fb-80c8-401d-8e9b-d58463f5e954.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cisplatin	CISPLATIN	WG Critical Care, LLC	508496cb-3441-46b3-a4fe-e0d440e6adc6	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018057 application number: NDA018057
CISplatin	CISPLATIN	WG Critical Care, LLC	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	2021-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018057 application number: NDA018057 ndc (product): 44567-511

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	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	5
309311	cisplatin 1 MG/ML Injectable Solution	SCD	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	5
309311	cisplatin 100 MG per 100 ML Injectable Solution	SY	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	5
309311	cisplatin 50 MG per 50 ML Injectable Solution	SY	2bf8d2fb-80c8-401d-8e9b-d58463f5e954	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
44567-511-01	44567051101	1 VIAL, MULTI-DOSE in 1 CARTON (44567-511-01) / 200 mL in 1 VIAL, MULTI-DOSE	2015-04-15	0000-00-00	No	No	Current