SIMBRINZA
- Product NDC
- 0065-4147
- 11-digit product format
- 000654147
- Labeler code
- 0065
- Product ID
- 0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brinzolamide/brimonidine tartrate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA204251
- Marketing category
- NDA
- Marketing start
- 2013-05-06
- Substance
- BRIMONIDINE TARTRATE; BRINZOLAMIDE
- Active strength
- 2; 10 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIMBRINZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 2 mg/mL |
| BRINZOLAMIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H, 9451Z89515 |
| Rxcui | 1421451, 1421456 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-4147-25 | SIMBRINZA | 2.5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 2.5 | | 19 |
| 0065-4147-25 | SIMBRINZA | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 19 |
| 0065-4147-27 | SIMBRINZA | 8 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 8 | | 19 |
| 0065-4147-27 | SIMBRINZA | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-4147 | SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20250316_a49c157e-6310-0011-7b7f-e26fc1820d59.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-4147-25 | 00065414725 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2013-05-06 | 0000-00-00 | Yes | No | Current |
| 0065-4147-27 | 00065414727 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER | 2013-05-06 | 0000-00-00 | No | No | Current |