Prescription drug · NDA
Simbrinza (brinzolamide/brimonidine tartrate) NDC 0065-4147
Brinzolamide 10 mg/mL; Brimonidine tartrate 2 mg/mL · Suspension/ drops · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-4147-25 | 00065414725 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from May 6, 2013 · Sample package | |
| 0065-4147-27 | 00065414727 | 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPERMarketed from May 6, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Simbrinza
- Generic name (nonproprietary)
- brinzolamide/brimonidine tartrate
- Active ingredients
- Brinzolamide — 10 mg/mLBrimonidine tartrate — 2 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204251
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994aSPL ID 889225d1-6257-4b32-b9cc-5f9c459c994aSPL set ID a49c157e-6310-0011-7b7f-e26fc1820d59RxCUI 1421451, 1421456UNII 9451Z89515, 4S9CL2DY2H
- Pharmacologic class
- Carbonic Anhydrase Inhibitor; alpha-Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400065414725followed by a unit qualifier and the quantityPackage 00065-4147-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. SIMBRINZA is a combination of brinzolamide, a carbonic anhydrase inhibitor, and brimonidine tartrate, an alpha adrenergic agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)
Excerpt only. Read the full label for complete information.