FDA.reportPublic FDA data

BRINZOLAMIDE

Product NDC
0574-4012
11-digit product format
005744012
Labeler code
0574
Product ID
0574-4012_071072b1-f9f8-4267-aa04-848d27e0e902
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA211914
Marketing category
ANDA
Marketing start
2023-10-10
Substance
BRINZOLAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRINZOLAMIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRINZOLAMIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9451Z89515
Rxcui308805

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d597d8a7-d57c-dd3a-cf57-7366f3edcf30Product name420240828
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-4012-10BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS14
0574-4012-10BRINZOLAMIDE10 mL in 1 BOTTLESUSPENSION/ DROPS104
0574-4012-15BRINZOLAMIDE15 mL in 1 BOTTLESUSPENSION/ DROPS154
0574-4012-15BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4012-10ML - Milliliter0574-4012c13aa8db-d8d7-4df6-93b0-c296878754fa12023-10-16
0574-4012-15ML - Milliliter0574-40125bd535ec-18db-4ead-92e5-173d1f373f5e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4012BRINZOLAMIDE SUSPENSION/ DROPS [PADAGIS US LLC]3Current NDC, 4 package rows20240915_b56a2e4b-7502-4831-a5b1-0370bdb987b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308805brinzolamide 1 % Ophthalmic SuspensionPSN460baf5f-1d47-4ae0-b635-84507c3b028d100
308805brinzolamide 10 MG/ML Ophthalmic SuspensionSCD460baf5f-1d47-4ae0-b635-84507c3b028d100
308805brinzolamide 1 % Ophthalmic SuspensionSY460baf5f-1d47-4ae0-b635-84507c3b028d100
308805brinzolamide 1 % Ophthalmic SuspensionPSNb56a2e4b-7502-4831-a5b1-0370bdb987b14
308805brinzolamide 10 MG/ML Ophthalmic SuspensionSCDb56a2e4b-7502-4831-a5b1-0370bdb987b14
308805brinzolamide 1 % Ophthalmic SuspensionSYb56a2e4b-7502-4831-a5b1-0370bdb987b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0574-4012-10005744012101 BOTTLE in 1 CARTON (0574-4012-10) / 10 mL in 1 BOTTLE1 bottle2023-10-10NoNoCurrent
0574-4012-15005744012151 BOTTLE in 1 CARTON (0574-4012-15) / 15 mL in 1 BOTTLE1 bottle2023-10-10NoNoCurrent