BRINZOLAMIDE

Product NDC
24208-464
11-digit product format
242080464
Labeler code
24208
Product ID
24208-464_1cebefb6-a5b0-e963-e063-6294a90a434f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA204884
Marketing category
ANDA
Marketing start
2022-03-31
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
A204884-001BRINZOLAMIDEBRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204884-001AB

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 06:07:402026-07A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204884-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2021-08-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204884-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204884-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204884-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204884-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204884-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204884-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204884-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204884-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204884-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204884-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204884-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204884-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204884-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204884-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204884-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204884-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204884-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204884-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A204884-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204884-001AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204884-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204884-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204884-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204884-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204884-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204884-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204884-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204884-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204884-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204884-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204884-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204884-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204884-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204884-001AB1a50c72e98297…

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
37b19837-fcab-4536-abad-6f4f92dfe794Available 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
24208-464-10BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS17
24208-464-10BRINZOLAMIDE10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS107
24208-464-15BRINZOLAMIDE15 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS157
24208-464-15BRINZOLAMIDE1 in 1 CARTONSUSPENSION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-464-10ML - Milliliter24208-4648dfa627f-de93-4e41-b659-e6aeacf7fa9a12025-10-14
24208-464-15ML - Milliliter24208-46414549ae3-7925-41ed-8534-7482316065c012025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-464BRINZOLAMIDE SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7Current NDC, Legacy NDC, 4 package rows20240711_37b19837-fcab-4536-abad-6f4f92dfe794.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
BRINZOLAMIDEBRINZOLAMIDEOceanside Pharmaceuticals.fb7229d4-522e-4cb2-b513-9d34f3ded5912026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204884
application number: ANDA204884
BRINZOLAMIDEBRINZOLAMIDEBausch & Lomb Incorporated37b19837-fcab-4536-abad-6f4f92dfe7942024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204884
application number: ANDA204884
ndc (product): 24208-464

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308805brinzolamide 1 % Ophthalmic SuspensionPSN37b19837-fcab-4536-abad-6f4f92dfe7947
308805brinzolamide 10 MG/ML Ophthalmic SuspensionSCD37b19837-fcab-4536-abad-6f4f92dfe7947
308805brinzolamide 1 % Ophthalmic SuspensionSY37b19837-fcab-4536-abad-6f4f92dfe7947

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-464-10242080464101 BOTTLE, PLASTIC in 1 CARTON (24208-464-10) / 10 mL in 1 BOTTLE, PLASTIC2022-03-310000-00-00NoNoCurrent
24208-464-15242080464151 BOTTLE, PLASTIC in 1 CARTON (24208-464-15) / 15 mL in 1 BOTTLE, PLASTIC2022-03-310000-00-00NoNoCurrent