50384-6700 NDC - NILOTINIB HYDROCHLORIDE

Drug Information

Product NDC: 50384-6700
Proprietary Name:
Non Proprietary Name: Nilotinib Hydrochloride
Active Ingredient(s): 350 kg/350kg NILOTINIB HYDROCHLORIDE MONOHYDRATE
Administration Route(s):
Dosage Form(s): POWDER

Labeler Information

Field Name	Field Value
Labeler Name:	Sterling Pharma Solutions Limited
Product Type:	BULK INGREDIENT
FDA Application Number:
Marketing Category:	BULK INGREDIENT
Start Marketing Date:	7/3/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	50384-6700-1	350 kg in 1 BAG (50384-6700-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	50384-6700	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	BULK INGREDIENT	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
NON PROPRIETARY NAME	Nilotinib Hydrochloride	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	POWDER	The translation of the dosage form Code submitted by the firm.
START MARKETING DATE	7/3/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	BULK INGREDIENT	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Sterling Pharma Solutions Limited	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	NILOTINIB HYDROCHLORIDE MONOHYDRATE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	350
ACTIVE INGRED UNIT	kg/350kg

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This page was last updated on: 12/19/2025

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