NDC 0065-0245-15 - Betoptic

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: 0065-0245
Requested NDC: 0065-0245-15
Package NDCs from labels: 0065-0245-20, 0065-0245-05, 0065-0245-10, 0065-0245-15
Manufacturer: Alcon
Effective date: 2006-10-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Betoptic - Alcon	Alcon	2006-10-30	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0245-05	Betoptic	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5	1
0065-0245-10	Betoptic	10 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	10	1
0065-0245-15	Betoptic	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	1
0065-0245-20	Betoptic	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	2.5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0245	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1	4 package rows	20080313_31b9b263-11fd-4495-83dd-ababf0d70e9e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
betaxolol hydrochloride	ACTIVE INGREDIENT	6X97D2XT0O	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
betaxolol	ACTIVE MOIETY	O0ZR1R6RZ2	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
benzalkonium chloride	INACTIVE INGREDIENT		BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
hydrochloric acid and/or sodium hydroxide	INACTIVE INGREDIENT		BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BETOPTIC (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [ALCON]	1

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betaxolol Hydrochloride	BETAXOLOL HYDROCHLORIDE	Sandoz Inc	a73519d5-546c-4377-92ed-0d4be2685d60	2023-10-31	Warnings, Adverse reactions	Exact identifier rxcui: 308720
0586E0A0-1962-3D4A-1A09-A543AF931CDF			31b9b263-11fd-4495-83dd-ababf0d70e9e	2006-10-30	Warnings, Adverse reactions	Exact identifier spl id: 0586E0A0-1962-3D4A-1A09-A543AF931CDF spl set id: 31b9b263-11fd-4495-83dd-ababf0d70e9e

Reported adverse events (FAERS/openFDA)#

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