Oxaliplatin

Product NDC: 68083-177
11-digit product format: 680830177
Labeler code: 68083
Product ID: 68083-177_4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaliplatin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA207325
Marketing category: ANDA
Marketing start: 2017-11-06
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxaliplatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXALIPLATIN	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04ZR38536J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1736776	Internal RxNorm lookup
1736781	Internal RxNorm lookup
1797528	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6f89dc3-a594-4b5b-8728-272e20c1ecb5	Available on FDA.report

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
68083-177-01	Oxaliplatin	20 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	20		10
68083-177-01	Oxaliplatin	1 in 1 CARTON	INJECTION, SOLUTION	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-177	OXALIPLATIN INJECTION, SOLUTION [GLAND PHARMA LIMITED]	10	Current NDC, Legacy NDC, 2 package rows	20230826_a6f89dc3-a594-4b5b-8728-272e20c1ecb5.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 · 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 ndc (product): 68083-177

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	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1797528	oxaliplatin 200 MG in 40 ML Injection	PSN	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1736776	oxaliplatin 50 MG in 10 ML Injection	PSN	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1736776	10 ML oxaliplatin 5 MG/ML Injection	SCD	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1736781	20 ML oxaliplatin 5 MG/ML Injection	SCD	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1797528	40 ML oxaliplatin 5 MG/ML Injection	SCD	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1736781	oxaliplatin 100 MG per 20 ML Injection	SY	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1797528	oxaliplatin 200 MG per 40 ML Injection	SY	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10
1736776	oxaliplatin 50 MG per 10 ML Injection	SY	a6f89dc3-a594-4b5b-8728-272e20c1ecb5	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-177-01	68083017701	1 VIAL, SINGLE-USE in 1 CARTON (68083-177-01) / 20 mL in 1 VIAL, SINGLE-USE	2017-11-06	0000-00-00	No	No	Current