BRINZOLAMIDE

Product NDC
68682-464
11-digit product format
686820464
Labeler code
68682
Product ID
68682-464_4fe88efe-d05e-0f99-e063-6294a90a51d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Oceanside Pharmaceuticals.
Application
ANDA204884
Marketing category
ANDA
Marketing start
2021-08-25
Marketing end
2028-01-31
Substance
BRINZOLAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRINZOLAMIDE

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-464-10BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS12
68682-464-10BRINZOLAMIDE10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS102
68682-464-15BRINZOLAMIDE15 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS152
68682-464-15BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-464-10ML - Milliliter68682-464e031879e-6838-475f-a0fb-05aa7acd5cfa12022-02-07
68682-464-15ML - Milliliter68682-464b604b222-de7b-4394-b4a5-8c7dad3c804e12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-464BRINZOLAMIDE SUSPENSION/ DROPS [OCEANSIDE PHARMACEUTICALS.]1Current NDC, Legacy NDC, 4 package rows20210827_fb7229d4-522e-4cb2-b513-9d34f3ded591.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308805brinzolamide 1 % Ophthalmic SuspensionPSNfb7229d4-522e-4cb2-b513-9d34f3ded5912
308805brinzolamide 10 MG/ML Ophthalmic SuspensionSCDfb7229d4-522e-4cb2-b513-9d34f3ded5912
308805brinzolamide 1 % Ophthalmic SuspensionSYfb7229d4-522e-4cb2-b513-9d34f3ded5912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-464-10686820464101 BOTTLE, PLASTIC in 1 CARTON (68682-464-10) / 10 mL in 1 BOTTLE, PLASTIC2021-08-252028-01-31NoNoCurrent
68682-464-15686820464151 BOTTLE, PLASTIC in 1 CARTON (68682-464-15) / 15 mL in 1 BOTTLE, PLASTIC2021-08-252028-01-31NoNoCurrent