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

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

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

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

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

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

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

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

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