FDA.reportPublic FDA data

NDC 72162-2387-7 - DORZOLAMIDE HYDROCHLORIDE AND 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
72162-2387
Requested NDC
72162-2387-7
Package NDCs from labels
72162-2387-7, 72162-2387-6
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2387-6DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE4 in 1 CARTONSOLUTION/ DROPS4100
72162-2387-7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.2100
72162-2387-7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE15 in 1 POUCHSOLUTION/ DROPS15100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2387DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE) SOLUTION/ DROPS [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20240822_cfdc5577-fe7a-4b51-b2f5-95806e1dee2d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2387-6EA - Each72162-2387cddde797-e756-49b4-97a0-ea41a25e5c9112024-11-05
72162-2387-7EA - Each72162-2387a07ea471-fc47-4fbd-9af7-30bfaff87d8f12025-01-14

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 3 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEMicro Labs Limitedb0a1d984-efee-4751-9797-c09adc2d307d2026-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA215936
ndc (product): 42571-382
rxcui: 1922783
spl id: 50aa565b-e11f-8176-e063-6294a90ab0b5
spl set id: b0a1d984-efee-4751-9797-c09adc2d307d
unii: QZO5366EW7
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
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
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
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
COMBIGANBRIMONIDINE TARTRATE, TIMOLOL MALEATEAllergan, Inc.feaf1480-a4b8-4486-992a-96be3a5962432026-03-17Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATESandoz Incf949fa34-6a9a-40d5-91ab-ff1cbb79b9ea2026-02-20Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESagent Pharmaceuticals0246463c-6c24-4611-8e22-2d5254ace66a2026-01-09Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Timolol MaleateTIMOLOL MALEATESagent Pharmaceuticals272bb565-f099-4896-b2f6-48ab9180e9412026-01-09Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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