OXALIPLATIN

Product NDC: 0955-1733
11-digit product format: 009551733
Labeler code: 0955
Product ID: 0955-1733_a3b6a85b-9240-4073-a7f9-1d82644eace0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxaliplatin
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Winthrop U.S.
Application: NDA021759
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-09-01
Marketing end: 0000-00-00
Substance: OXALIPLATIN
Active strength: 5 mg/mL
Pharmacologic classes: Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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	0955-1733		D	Discontinued by firm		2026-10-15
excluded package	package	0955-1733	0955-1733-20	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021759-001	ELOXATIN	OXALIPLATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31
N021759-002	ELOXATIN	OXALIPLATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31
N021759-003	ELOXATIN	OXALIPLATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021759-003	ELOXATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	RLD	2005-01-31	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021759-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021759-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021759-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021759-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021759-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021759-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021759-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021759-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021759-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021759-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021759-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021759-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021759-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021759-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021759-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021759-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0364c41f-a4ea-b691-2739-986f76e794e5	Product name	9	20190125
b153e9b5-916b-4df6-8413-d22b82f1d312	Product name	2	20170720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0955-1733-20	OXALIPLATIN	20 mL in 1 VIAL, GLASS	INJECTION, SOLUTION, CONCENTRATE	20		10
0955-1733-20	OXALIPLATIN	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-1733-20	ML - Milliliter	0955-1733	be4ae6d6-6bb4-426d-bf94-37d1d16fddc0	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
oxaliplatin	ACTIVE INGREDIENT	04ZR38536J	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]	2
oxaliplatin	ACTIVE MOIETY	04ZR38536J	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0955-1733	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	10	Legacy NDC, 2 package rows	20231208_70269278-fe61-4800-a064-32cb6845cc28.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04ZR38536J	OXALIPLATIN	61825-94-3	OXALIPLATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1736781	oxaliplatin 100 MG in 20 ML Injection	PSN	70269278-fe61-4800-a064-32cb6845cc28	10
1736776	oxaliplatin 50 MG in 10 ML Injection	PSN	70269278-fe61-4800-a064-32cb6845cc28	10
1736776	10 ML oxaliplatin 5 MG/ML Injection	SCD	70269278-fe61-4800-a064-32cb6845cc28	10
1736781	20 ML oxaliplatin 5 MG/ML Injection	SCD	70269278-fe61-4800-a064-32cb6845cc28	10
1736781	oxaliplatin 100 MG per 20 ML Injection	SY	70269278-fe61-4800-a064-32cb6845cc28	10
1736776	oxaliplatin 50 MG per 10 ML Injection	SY	70269278-fe61-4800-a064-32cb6845cc28	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0955-1733-20	00955173320	1 VIAL, GLASS in 1 CARTON (0955-1733-20) > 20 mL in 1 VIAL, GLASS	2015-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXALIPLATIN	Winthrop U.S, a business of sanofi-aventis U.S. LLC \| Sanofi-Aventis Deutschland GmbH \| Johnson Matthey Inc.	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	10