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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211914-001BRINZOLAMIDEBRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2023-07-289b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211914-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMIC2023-07-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211914-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211914-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211914-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211914-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211914-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211914-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211914-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211914-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211914-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211914-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211914-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211914-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211914-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211914-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211914-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211914-001AB19b2671bbb829…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211914-001CGT2024-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211914-001CGT2024-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211914-001CGT2024-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211914-001CGT2024-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211914-001CGT2024-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211914-001CGT2024-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211914-001CGT2024-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211914-001CGT2024-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211914-001CGT2024-04-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211914-001CGT2024-04-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211914-001CGT2024-04-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211914-001CGT2024-04-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211914-001CGT2024-04-07a72a2bbeb626…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9451Z89515Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308805Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b56a2e4b-7502-4831-a5b1-0370bdb987b1Available on FDA.report

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

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRINZOLAMIDEBRINZOLAMIDEPadagis US LLCb56a2e4b-7502-4831-a5b1-0370bdb987b12024-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211914
application number: ANDA211914
ndc (product): 0574-4012
BRINZOLAMIDEBRINZOLAMIDEBryant Ranch Prepack460baf5f-1d47-4ae0-b635-84507c3b028d2023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211914
application number: ANDA211914

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