FDA.reportPublic FDA data

Brinzolamide

Product NDC
0591-2127
Requested package NDC
0591-2127-12
11-digit product format
005912127
Labeler code
0591
Product ID
0591-2127_a46858f8-330d-471c-bec5-7816a17fd3d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brinzolamide
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Actavis Pharma, Inc.
Application
ANDA209406
Marketing category
ANDA
Marketing start
2021-03-08
Marketing end
0000-00-00
Substance
BRINZOLAMIDE
Active strength
10 mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0591-21270591-2127-12DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209406-001BRINZOLAMIDEBRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2020-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209406-001AB

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
2026-08-01 22:54:322026-06A209406-001BRINZOLAMIDE1%SUSPENSION/DROPS / OPHTHALMICAB2020-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209406-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d597d8a7-d57c-dd3a-cf57-7366f3edcf30Product name420240828

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2127-12ML - Milliliter0591-21275e5522f9-66d6-4276-90e4-37a6926b011812021-04-08
0591-2127-79ML - Milliliter0591-2127828d3bc4-99fe-4fd1-97b8-fd1a0fd6c33112021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2127BRINZOLAMIDE SUSPENSION/ DROPS [ACTAVIS PHARMA, INC.]12Legacy NDC20241218_ec29d07f-99ac-45ed-af0a-d9b7d1a8c032.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2127-12005912127121 BOTTLE, PLASTIC in 1 CARTON (0591-2127-12) > 15 mL in 1 BOTTLE, PLASTIC2021-03-080000-00-00NoNoCurrent