NDC 0065-4147
SIMBRINZA
Brinzolamide/brimonidine Tartrate
SIMBRINZA is a Ophthalmic Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Brinzolamide; Brimonidine Tartrate.
| Product ID | 0065-4147_3f6a7e6a-1383-4eda-8d2a-a167cb98c9e6 |
| NDC | 0065-4147 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SIMBRINZA |
| Generic Name | Brinzolamide/brimonidine Tartrate |
| Dosage Form | Suspension/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2013-05-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA204251 |
| Labeler Name | Alcon Laboratories, Inc. |
| Substance Name | BRINZOLAMIDE; BRIMONIDINE TARTRATE |
| Active Ingredient Strength | 10 mg/mL; mg/mL |
| Pharm Classes | Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0065-4147-25
1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) > 2.5 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2013-05-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0065-4147-27 [00065414727]
SIMBRINZA SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA204251 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-05-01 |
NDC 0065-4147-25 [00065414725]
SIMBRINZA SUSPENSION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA204251 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-05-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BRINZOLAMIDE | 10 mg/mL |
OpenFDA Data
| SPL SET ID: | a49c157e-6310-0011-7b7f-e26fc1820d59 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Carbonic Anhydrase Inhibitor [EPC]
- Carbonic Anhydrase Inhibitors [MoA]
- Adrenergic alpha-Agonists [MoA]
- alpha-Adrenergic Agonist [EPC]
NDC Crossover Matching brand name "SIMBRINZA" or generic name "Brinzolamide/brimonidine Tartrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0065-4147 | SIMBRINZA | brinzolamide/brimonidine tartrate |
| 0078-0904 | SIMBRINZA | brinzolamide/brimonidine tartrate |
Trademark Results [SIMBRINZA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMBRINZA 85306875 4388553 Live/Registered |
Novartis AG 2011-04-28 |
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