Oxaliplatin

Product NDC: 79672-826
11-digit product format: 796720826
Labeler code: 79672
Product ID: 79672-826_7c421a07-6b7a-4cff-a9dd-b7d6ca44debd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXALIPLATIN
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR 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: 100 mg/20mL
Pharmacologic classes: Platinum-based Drug [EPC],Platinum-containing Compounds [EXT]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	79672-826		I	Inactivated by FDA		2026-08-03
excluded package	package	79672-826	79672-826-02	I	Inactivated by FDA		2026-08-03

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79672-826-02	2026-01-29	C162847	48780-1	49896155-ae2e-586f-e063-e6dba90add90	These highlights do not include all the information needed to use OXALIPLATIN FOR INJECTION safely and effectively. See full prescribing information for OXALIPLATIN FOR INJECTION. OXALIPLATIN for injection, for intravenous use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79672-826-02	Oxaliplatin	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		3
79672-826-02	Oxaliplatin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
79672-826-02	EA - Each	79672-826	2ac46b91-3324-483a-a674-82d669dcffc1	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79672-826	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NEXTGEN PHARMACEUTICALS LLC]	3	Legacy NDC, 2 package rows	20231226_95b05292-36a1-4946-b8b3-835a3a77f4a7.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	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

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
1736786	oxaliplatin 100 MG Injection	PSN	95b05292-36a1-4946-b8b3-835a3a77f4a7	3
1736784	oxaliplatin 50 MG Injection	PSN	95b05292-36a1-4946-b8b3-835a3a77f4a7	3
1736786	oxaliplatin 100 MG Injection	SCD	95b05292-36a1-4946-b8b3-835a3a77f4a7	3
1736784	oxaliplatin 50 MG Injection	SCD	95b05292-36a1-4946-b8b3-835a3a77f4a7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79672-826-02	79672082602	1 VIAL in 1 CARTON (79672-826-02) > 20 mL in 1 VIAL	1 vial	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxaliplatin	Nextgen Pharmaceuticals LLC \| Qilu Pharmaceutical Co., Ltd. \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2023-12-26	HUMAN PRESCRIPTION DRUG LABEL	3