Oxaliplatin

Product NDC: 79672-018
11-digit product format: 796720018
Labeler code: 79672
Product ID: 79672-018_b077e8c7-6521-0da6-e053-2a95a90a2445
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXALIPLATIN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Nextgen Pharmaceuticals LLC
Application: ANDA204616
Marketing category: ANDA
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: OXALIPLATIN
Active strength: 50 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	79672-018		D	Discontinued by firm		2026-08-03
excluded package	package	79672-018	79672-018-01	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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`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	79672-018-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204616-001	OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP		2016-05-11
A204616-002	OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP		2016-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204616-001	AP
A204616-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204616-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204616-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2016-05-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A204616-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204616-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204616-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204616-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204616-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204616-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204616-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204616-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204616-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204616-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204616-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204616-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204616-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204616-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204616-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204616-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204616-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204616-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204616-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204616-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204616-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204616-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204616-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204616-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204616-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204616-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204616-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204616-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204616-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204616-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204616-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204616-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204616-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204616-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204616-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204616-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204616-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204616-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204616-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204616-002	AP	1	`782e0a99824c…`

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	Qilu Pharmaceutical Co., Ltd.	e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64	2021-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204616 application number: ANDA204616