simbrinza

Generic: brinzolamide/brimonidine tartrate

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name simbrinza
Generic Name brinzolamide/brimonidine tartrate
Labeler alcon laboratories, inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

brimonidine tartrate 2 mg/mL, brinzolamide 10 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-4147
Product ID 0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204251
Listing Expiration 2026-12-31
Marketing Start 2013-05-06

Pharmacologic Class

Established (EPC)
carbonic anhydrase inhibitor [epc]
Mechanism of Action
carbonic anhydrase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00654147
Hyphenated Format 0065-4147

Supplemental Identifiers

RxCUI
1421451 1421456
UNII
4S9CL2DY2H 9451Z89515
NUI
N0000175517 N0000000235

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simbrinza (source: ndc)
Generic Name brinzolamide/brimonidine tartrate (source: ndc)
Application Number NDA204251 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0065-4147-25 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER 0065-4147-27 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER

Ingredients (2)

brimonidine tartrate (2 mg/mL) brinzolamide (10 mg/mL)

Linked Drug Pages (1)

SIMBRINZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "889225d1-6257-4b32-b9cc-5f9c459c994a", "openfda": {"nui": ["N0000175517", "N0000000235"], "unii": ["4S9CL2DY2H", "9451Z89515"], "rxcui": ["1421451", "1421456"], "spl_set_id": ["a49c157e-6310-0011-7b7f-e26fc1820d59"], "pharm_class_epc": ["Carbonic Anhydrase Inhibitor [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4147-25", "marketing_start_date": "20130506"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27)  / 8 mL in 1 BOTTLE, DROPPER", "package_ndc": "0065-4147-27", "marketing_start_date": "20130506"}], "brand_name": "SIMBRINZA", "product_id": "0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0065-4147", "generic_name": "brinzolamide/brimonidine tartrate", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMBRINZA", "active_ingredients": [{"name": "BRIMONIDINE TARTRATE", "strength": "2 mg/mL"}, {"name": "BRINZOLAMIDE", "strength": "10 mg/mL"}], "application_number": "NDA204251", "marketing_category": "NDA", "marketing_start_date": "20130506", "listing_expiration_date": "20261231"}