NDC 47335-362 - decitabine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 47335-362
Package NDCs from labels: 47335-362-40
Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited
Effective date: 2020-07-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
decitabine - Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2020-07-23	Human Prescription Drug Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-362	DECITABINE KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12	Unmatched	20200729_c155d6ba-9a16-406c-919e-65a149689ab9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
DECITABINE	ACTIVE INGREDIENT	776B62CQ27	DECITABINE KIT [SUN PHARMA GLOBAL FZE]	5
DECITABINE	ACTIVE MOIETY	776B62CQ27	DECITABINE KIT [SUN PHARMA GLOBAL FZE]	5

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 10 of 11 · 206 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
DECITABINE	DECITABINE	Nivagen Pharmaceuticals, Inc.	150537a8-10ac-422d-bf33-68b1a408e566	2022-02-28	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Decitabine	DECITABINE	Qilu Pharmaceutical Co., Ltd.	5b2dce6f-c715-47dc-971e-06244ccd7548	2021-10-18	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
decitabine	DECITABINE	Gland Pharma Limited	39a26b24-e9d4-4974-9788-d025c51fc94f	2021-09-15	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
FERRUM PHOSPHORICUM 6X	HYDRATED IRON III PHOSPHATE	Seroyal USA	14f4f926-0742-12cd-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 4J9FJ0HL51
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Decitabine	DECITABINE	Amneal Pharmaceuticals LLC	40e7ef72-8df5-4adf-a269-4ae1c26eb6f9	2021-02-12	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	a1b43089-bc88-4ac6-bdee-9cc38ec30f4e	2021-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Decitabine	DECITABINE	Northstar Rx LLC	1abbe952-58bc-4dbc-b06a-fb79167bcd66	2020-08-17	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	ae6c4580-3a3a-4c42-903a-1565d79521f8	2020-08-01	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
Decitabine	DECITABINE	Mylan Institutional LLC	447a9fbd-106d-4ff6-8fd0-bb38a8c90e17	2020-07-26	Warnings, Adverse reactions	Exact identifier rxcui: 636631 unii: 776B62CQ27
decitabine	DECITABINE	Sun Pharmaceutical Industries, Inc.	c155d6ba-9a16-406c-919e-65a149689ab9	2020-07-23	Warnings, Adverse reactions	Exact identifier application number: NDA205582 ndc (package): 47335-362-40 ndc (package): 47335-361-41 ndc (product): 47335-361 rxcui: 636631 spl id: ddc155a1-509c-4d7e-bab1-fa5891ef354e spl set id: c155d6ba-9a16-406c-919e-65a149689ab9
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Dextrose and Electrolyte No. 48	SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	b283a454-0c20-4fbf-92d3-dae1f3cd3cad	2020-02-13	Warnings, Adverse reactions	Exact identifier unii: 4J9FJ0HL51
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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