OXALIPLATIN

Product NDC: 0955-1727
Requested package NDC: 0955-1727-20
11-digit product format: 009551727
Labeler code: 0955
Product ID: 0955-1727_dfd7b336-3bf2-43e1-8197-06d85be3fe11
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: 2014-07-07
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0955-1727	0955-1727-20	D	Discontinued by firm		2026-08-11

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021759-002	ELOXATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2005-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021759-001	ELOXATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2005-01-31	`8072bd15b7f6…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0955-1727-20	2025-08-25	C162847	48780-1	2cef2736-a327-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use oxaliplatin safely and effectively. See full prescribing information for oxaliplatin. OXALIPLATIN INJECTION, for intravenous use Initial U.S. Approval: 2002
0955-1727-20	2025-01-30	C162847	48780-1	2cef2736-a327-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use oxaliplatin safely and effectively. See full prescribing information for oxaliplatin. OXALIPLATIN INJECTION, for intravenous use Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0955-1727-20	ML - Milliliter	0955-1727	e97398b8-ab37-491c-a2c4-85a42a70955a	1	2014-08-01

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.]	5
oxaliplatin	ACTIVE MOIETY	04ZR38536J	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0955-1727	OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S, A BUSINESS OF SANOFI-AVENTIS U.S. LLC]	16	Legacy NDC	20231208_a98b4070-822f-4fba-a844-690ff5556f0b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXALIPLATIN	OXALIPLATIN	Winthrop U.S, a business of sanofi-aventis U.S. LLC	70269278-fe61-4800-a064-32cb6845cc28	2023-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021759 application number: NDA021759

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0955-1727-20	00955172720	1 VIAL, GLASS in 1 CARTON (0955-1727-20) > 20 mL in 1 VIAL, GLASS	2014-07-07	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	16