FDA.reportPublic FDA data

NDC 50090-7837-00 - Timolol Maleate

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
50090-7837
Requested NDC
50090-7837-00
Package NDCs from labels
50090-7837-0, 50090-7837-00
Manufacturer
A-S Medication Solutions
Effective date
2025-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Timolol Maleate - A-S Medication SolutionsA-S Medication Solutions2025-12-30Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7837-0Timolol Maleate10 mL in 1 BOTTLESOLUTION101
50090-7837-0Timolol Maleate1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7837-0ML - Milliliter50090-78377bf4d38f-3d87-4e03-84e1-9fedb47cf8b112026-02-05

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 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions64561dfd-3704-4820-aef6-d0d26cef72552026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 1992303
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol Maleate Preservative FreeDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEAurobindo Pharma Limitedf41a9cd5-48c8-42eb-bb1b-d0355d9812012026-08-13Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEAurobindo Pharma Limited2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e12026-08-13Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timoptic in OcudoseTIMOLOL MALEATENordic Pharma, Inc.16323b0e-78ae-40e5-be93-04f698dd672b2026-08-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate and Timolol maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGland Pharma Limited038cf2ba-ad08-4981-a3cc-bff0e4ba5dfb2026-06-16Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepack09dbed18-9076-4891-93a7-d14bb22179262026-06-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC02d89d37-cbca-4e06-83ef-2a10f988f1ea2026-06-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE AND TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC7011a203-46cf-434d-ba11-253f107ff80f2026-05-27Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
COSOPT PFDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEThea Pharma Inc.535fc801-8c3f-4974-a120-3eff1d5a50622026-05-13Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate/Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGlenmark Pharmaceuticals Inc., USAbf6a7f59-5a10-49fe-9e57-19e3ba2029182026-05-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackff76c0cf-256c-4015-94f4-405f0c46205f2026-05-01Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEMicro Labs Limitedb0a1d984-efee-4751-9797-c09adc2d307d2026-04-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate/Timolol Maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEApotex Corp.268c3f6b-8798-7987-3b8c-7b7f560af5d72026-04-23Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEAlembic Pharmaceuticals Inc.10e79593-b991-4899-89fd-6fff7a213d812026-04-01Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATESandoz Incaf21d2e5-0029-4889-ba93-6417baa91ce62026-03-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
COMBIGANBRIMONIDINE TARTRATE, TIMOLOL MALEATEAllergan, Inc.feaf1480-a4b8-4486-992a-96be3a5962432026-03-17Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATESandoz Incf949fa34-6a9a-40d5-91ab-ff1cbb79b9ea2026-02-20Warnings, Adverse reactionsExact identifier
rxcui: 1992303
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATESagent Pharmaceuticals272bb565-f099-4896-b2f6-48ab9180e9412026-01-09Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATEA-S Medication Solutions7a1ea848-5b55-4038-afb1-029645ee09252025-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA218460
ndc (package): 50090-7837-0
ndc (product): 50090-7837
ndc11 (package): 50090783700
rxcui: 1992303
spl id: bc369d21-0492-493e-9929-2cae44fd9b9b
spl set id: 7a1ea848-5b55-4038-afb1-029645ee0925
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAEDDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEIndoco Remedies Limited0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b2025-12-22Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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