Oxaliplatin

Product NDC: 47335-178
11-digit product format: 473350178
Labeler code: 47335
Product ID: 47335-178_47ebaf59-b7c2-4f6b-bf3e-292da264662c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaliplatin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078818
Marketing category: ANDA
Marketing start: 2009-08-19
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: 2019-12-31
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	47335-178		I	Inactivated by FDA		2026-08-11
excluded package	package	47335-178	47335-178-40	I	Inactivated by FDA		2026-08-11

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 · 42 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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`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	47335-178-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	47335-178-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	47335-178-40	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	47335-178-40	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	47335-178-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	47335-178-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	47335-178-40	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	47335-178-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	47335-178-40	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	47335-178-40	`9bebd1f3094a…`	`5416666fcb17…`

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
A078818-001	OXALIPLATIN	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS			2009-08-07
A078818-002	OXALIPLATIN	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS			2009-08-07

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078818-001	OXALIPLATIN	50MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078818-002	OXALIPLATIN	100MG/VIAL	INJECTABLE / INTRAVENOUS	2009-08-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A078818-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078818-002	AP	1	`ea99ee380514…`

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
47335-178-40	2020-01-31	C162847	48780-1	9d75b9d0-e854-f424-e053-dadaa90a57ce	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, USP 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
47335-178-40	Oxaliplatin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		7
47335-178-40	Oxaliplatin	20 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	20		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-178-40	EA - Each	47335-178	adefe9d5-b68b-4574-9503-f5cb54e9bcfe	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXALIPLATIN	ACTIVE INGREDIENT	04ZR38536J	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	5
OXALIPLATIN	ACTIVE MOIETY	04ZR38536J	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-178	OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	7	Legacy NDC, 2 package rows	20181025_8efb4c07-455b-4c91-b257-6fd43854454c.zip

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	8efb4c07-455b-4c91-b257-6fd43854454c	7
1736784	oxaliplatin 50 MG Injection	PSN	8efb4c07-455b-4c91-b257-6fd43854454c	7
1736786	oxaliplatin 100 MG Injection	SCD	8efb4c07-455b-4c91-b257-6fd43854454c	7
1736784	oxaliplatin 50 MG Injection	SCD	8efb4c07-455b-4c91-b257-6fd43854454c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
47335-178-40	47335017840	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxaliplatin	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2018-10-25	Human Prescription Drug Label	7