NDC 0065-0850 - Betoptic Pilo

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
0065-0850
Package NDCs from labels
0065-0850-20
Manufacturer
Alcon Laboratories, Inc.
Effective date
2006-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Betoptic Pilo - Alcon Laboratories, Inc.Alcon Laboratories, Inc.2006-06-19Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0850-20Betoptic Pilo1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0850BETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]11 package rows20080313_4dd69142-d320-40d9-ad27-680b2fe7fd42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betaxolol HydrochlorideACTIVE INGREDIENT6X97D2XT0OBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Pilocarpine HydrochlorideACTIVE INGREDIENT0WW6D218XJBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
BetaxololACTIVE MOIETYO0ZR1R6RZ2BETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
PilocarpineACTIVE MOIETY01MI4Q9DI3BETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Boric acidINACTIVE INGREDIENTR57ZHV85D4BETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Carbomer 934PINACTIVE INGREDIENTBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
MannitolINACTIVE INGREDIENT3OWL53L36ABETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
poly(styrene-divinyl benzene) sulfonic acidINACTIVE INGREDIENTBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RBETOPTIC PILO (BETAXOLOL HYDROCHLORIDE AND PILOCARPINE HYDROCHLORIDE) [ALCON LABORATORIES, INC.]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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betoptic SBETAXOLOL HYDROCHLORIDENovartis Pharmaceuticals Corporation905ba189-456c-4aa4-8231-39a971374ad82025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 308719
4D3F099E-7F56-EE86-9507-018C8533A8744dd69142-d320-40d9-ad27-680b2fe7fd422006-06-19Warnings, Adverse reactionsExact identifier
spl id: 4D3F099E-7F56-EE86-9507-018C8533A874
spl set id: 4dd69142-d320-40d9-ad27-680b2fe7fd42

Reported adverse events (FAERS/openFDA)#

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