NDC codes

FDA NDC Directory
Product NDC (as listed)0065-4147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00065-4147Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0065-4147-2500065414725000654147251 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from May 6, 2013 · Sample package
0065-4147-2700065414727000654147271 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.NDC labeler code 0065
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

N400065414725 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0065-4147

What is NDC 0065-4147?
0065-4147 is the product NDC for Simbrinza (brinzolamide/brimonidine tartrate), Brinzolamide 10 mg/mL; Brimonidine tartrate 2 mg/mL suspension/ drops, listed with the FDA by Alcon Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Simbrinza (Brinzolamide/brimonidine tartrate).
What is the active ingredient?
Brinzolamide, Brimonidine tartrate.
Who is the labeler?
Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Simbrinza?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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