Oxaliplatin

Product NDC: 72266-126
11-digit product format: 722660126
Labeler code: 72266
Product ID: 72266-126_8a719215-d0a0-42fb-e053-2a95a90a60da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaliplatin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fosun Pharma USA Inc.
Application: ANDA207325
Marketing category: ANDA
Marketing start: 2019-02-15
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: 2020-12-31
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	72266-126		D	Discontinued by firm		2026-08-03
excluded package	package	72266-126	72266-126-10	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72266-126-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72266-126-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72266-126-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72266-126-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72266-126-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72266-126-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72266-126-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72266-126-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72266-126-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72266-126-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72266-126-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72266-126-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	RLD / RS	Approval date
A207325-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10
A207325-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10
A207325-003	OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207325-001	AP
A207325-002	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 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	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RS	2017-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2017-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207325-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A207325-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207325-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207325-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207325-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207325-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207325-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207325-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207325-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207325-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207325-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207325-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207325-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207325-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207325-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207325-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207325-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207325-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207325-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207325-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207325-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207325-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207325-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207325-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207325-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207325-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207325-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207325-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207325-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207325-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207325-001	AP	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-126-01	ML - Milliliter	72266-126	0f6ef6d3-a56d-48ae-b376-0f4c89259b4c	1	2019-06-19
72266-126-10	ML - Milliliter	72266-126	dfebc229-b6d7-4e37-8ad9-a1cdd16c4702	1	2019-06-19

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	NorthStar Rx LLC	f299b2d2-86ed-4fb8-822e-65455a0bb75a	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	7e38318e-c569-4ad4-8f10-a235f30444d1	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325
Oxaliplatin	OXALIPLATIN	Meitheal Pharmaceuticals Inc.	873fa936-157a-4f85-bc70-5df31d71d122	2024-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325
Oxaliplatin	OXALIPLATIN	FOSUN PHARMA USA INC.	fad0f147-6595-4412-87a7-2afca0192a96	2023-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325
Oxaliplatin	OXALIPLATIN	Gland Pharma Limited	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	2023-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207325 application number: ANDA207325

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72266-126-10	72266012610	10 CARTON in 1 BOX (72266-126-10) > 1 VIAL, SINGLE-USE in 1 CARTON (72266-126-01) > 20 mL in 1 VIAL, SINGLE-USE	10 carton	2019-04-02	0000-00-00	No	No	Current