Oxaliplatin

Product NDC: 60505-6287
Requested package NDC: 60505-6287-2
11-digit product format: 605056287
Labeler code: 60505
Product ID: 60505-6287_e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxaliplatin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Apotex Corp.
Application: ANDA204368
Marketing category: ANDA
Marketing start: 2024-04-23
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 43.

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
A204368-001	OXALIPLATIN	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07
A204368-002	OXALIPLATIN	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07
A204368-003	OXALIPLATIN	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204368-001	AP
A204368-002	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 · 129 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
2026-09-14 22:38:34	2026-08	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204368-002	OXALIPLATIN	100MG/20ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204368-003	OXALIPLATIN	200MG/40ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2016-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204368-001	OXALIPLATIN	50MG/10ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2016-06-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204368-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204368-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204368-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204368-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204368-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204368-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204368-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204368-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204368-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204368-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204368-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204368-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204368-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204368-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204368-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204368-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204368-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204368-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204368-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204368-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204368-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204368-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204368-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204368-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204368-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204368-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204368-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204368-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204368-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204368-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204368-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204368-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204368-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204368-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204368-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204368-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204368-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204368-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204368-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204368-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1736776	Internal RxNorm lookup
1736781	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
bb180ec5-1f75-43c1-9f63-c0657af2ca5f	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	SPL version
60505-6287-2	Oxaliplatin	10 mL in 1 VIAL	INJECTION, SOLUTION	10	2
60505-6287-2	Oxaliplatin	1 in 1 CARTON	INJECTION, SOLUTION	1	2
60505-6287-4	Oxaliplatin	20 mL in 1 VIAL	INJECTION, SOLUTION	20	2
60505-6287-4	Oxaliplatin	1 in 1 CARTON	INJECTION, SOLUTION	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6287-2	ML - Milliliter	60505-6287	69e9a3b7-14de-4f61-94f7-0a0ac66b8ab7	1	2024-05-16
60505-6287-4	ML - Milliliter	60505-6287	b2b048b8-0376-439b-b368-f8687a76e175	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6287	OXALIPLATIN INJECTION, SOLUTION [APOTEX CORP.]	1	Current NDC, 4 package rows	20240424_bb180ec5-1f75-43c1-9f63-c0657af2ca5f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaliplatin	OXALIPLATIN	BluePoint Laboratories	b6083405-9b45-4d2c-e053-2995a90ad9ef	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204368 application number: ANDA204368
Oxaliplatin	OXALIPLATIN	Qilu Pharmaceutical Co., Ltd.	33d4f4b4-bb4e-46af-9e89-df20154436d0	2024-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204368 application number: ANDA204368
Oxaliplatin	OXALIPLATIN	Apotex Corp.	ee5a5a1d-63f6-4d5a-901b-65be45ec6610	2024-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204368 application number: ANDA204368
Oxaliplatin	OXALIPLATIN	Apotex Corp.	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2024-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204368 application number: ANDA204368 ndc (package): 60505-6287-2 ndc (product): 60505-6287 ndc11 (package): 60505628702

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	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2
1736776	oxaliplatin 50 MG in 10 ML Injection	PSN	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2
1736776	10 ML oxaliplatin 5 MG/ML Injection	SCD	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2
1736781	20 ML oxaliplatin 5 MG/ML Injection	SCD	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2
1736781	oxaliplatin 100 MG per 20 ML Injection	SY	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2
1736776	oxaliplatin 50 MG per 10 ML Injection	SY	bb180ec5-1f75-43c1-9f63-c0657af2ca5f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60505-6287-2	60505628702	1 VIAL in 1 CARTON (60505-6287-2) / 10 mL in 1 VIAL	1 vial	2024-04-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxaliplatin	Apotex Corp. \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2024-08-04	HUMAN PRESCRIPTION DRUG LABEL	2