OXALIPLATIN

Product NDC: 0955-1731
11-digit product format: 009551731
Labeler code: 0955
Product ID: 0955-1731_0bef8406-8dab-0ad0-e063-6394a90a60d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxaliplatin
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Winthrop U.S, a business of sanofi-aventis U.S. LLC
Application: NDA021759
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-09-01
Substance: OXALIPLATIN
Active strength: 5 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	0955-1731		D	Discontinued by firm		2026-09-09
excluded package	package	0955-1731	0955-1731-10	D	Discontinued by firm		2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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N021759-001	ELOXATIN	OXALIPLATIN	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31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ELOXATIN	OXALIPLATIN	100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2005-01-31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ELOXATIN	OXALIPLATIN	200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS	RLD	2006-11-17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 · 126 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
2026-08-18 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RLD	2005-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2005-01-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021759-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021759-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021759-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021759-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021759-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021759-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021759-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021759-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021759-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021759-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021759-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021759-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021759-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021759-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021759-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021759-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021759-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021759-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021759-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021759-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021759-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021759-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021759-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021759-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021759-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021759-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021759-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021759-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021759-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021759-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021759-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021759-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021759-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021759-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021759-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021759-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021759-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021759-002	AP	1	`9b2671bbb829…`

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
0955-1731-10	OXALIPLATIN	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		10
0955-1731-10	OXALIPLATIN	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION, CONCENTRATE	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-1731-10	ML - Milliliter	0955-1731	4d9b28c0-8343-4160-910b-9a56e3bcef5b	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
0955-1731	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	10	Current NDC, 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
0955-1731-10	00955173110	1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 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