49873-044 NDC - SATO CLEAR (NAPHAZOLINE HYDROCHLORIDE)

Drug Information

Product NDC: 49873-044
Proprietary Name: Sato Clear
Non Proprietary Name: NAPHAZOLINE HYDROCHLORIDE
Active Ingredient(s): 12 mg/100mL NAPHAZOLINE HYDROCHLORIDE
Administration Route(s): OPHTHALMIC
Dosage Form(s): SOLUTION/ DROPS

Labeler Information

Field Name	Field Value
Labeler Name:	Sato Pharmaceutical Co., Ltd.
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M018
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	5/31/1989

Package Information

No.	Package Code	Package Description	Billing Unit
1	49873-044-01	1 BOTTLE, PLASTIC in 1 CARTON (49873-044-01) / 15 mL in 1 BOTTLE, PLASTIC

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	49873-044	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	HUMAN OTC DRUG	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.
PROPRIETARY NAME	Sato Clear	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NON PROPRIETARY NAME	NAPHAZOLINE 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	SOLUTION/ DROPS	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	OPHTHALMIC	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	5/31/1989	The translation of the route code submitted by the firm, indicating route of administration.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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.
APPLICATION NUMBER	M018	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	Sato Pharmaceutical Co., Ltd.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	NAPHAZOLINE HYDROCHLORIDE	Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH	12
ACTIVE INGRED UNIT	mg/100mL

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This page was last updated on: 11/21/2025

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