FDA.reportPublic FDA data

BRINZOLAMIDE

Product NDC
72162-2201
11-digit product format
721622201
Labeler code
72162
Product ID
72162-2201_584621b7-07b3-45c9-8e3d-8f21391cf3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
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
72162-2201-2BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS1100
72162-2201-2BRINZOLAMIDE10 mL in 1 BOTTLESUSPENSION/ DROPS10100
72162-2201-4BRINZOLAMIDE15 mL in 1 BOTTLESUSPENSION/ DROPS15100
72162-2201-4BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2201-2ML - Milliliter72162-2201ffa80e2b-dc23-4ffa-8ed8-26e9ee46b7c112024-02-14
72162-2201-4ML - Milliliter72162-2201c200a20d-e966-4523-8580-d6a76892e87912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2201BRINZOLAMIDE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20231223_460baf5f-1d47-4ae0-b635-84507c3b028d.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2201-2721622201021 BOTTLE in 1 CARTON (72162-2201-2) / 10 mL in 1 BOTTLE1 bottle2023-12-19NoNoCurrent
72162-2201-4721622201041 BOTTLE in 1 CARTON (72162-2201-4) / 15 mL in 1 BOTTLE1 bottle2023-12-19NoNoCurrent