What is NDC 0574-4012?

0574-4012 is the product NDC for Brinzolamide, Brinzolamide 10 mg/mL suspension/ drops, listed with the FDA by Padagis US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Brinzolamide?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Brinzolamide NDC 0574-4012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-4012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-4012Add 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 NDC	11-digit (billing)	Package	Copy
0574-4012-10	00574401210	1 BOTTLE in 1 CARTON (0574-4012-10) / 10 mL in 1 BOTTLEMarketed from Oct 10, 2023
0574-4012-15	00574401215	1 BOTTLE in 1 CARTON (0574-4012-15) / 15 mL in 1 BOTTLEMarketed from Oct 10, 2023

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): Brinzolamide
Generic name (nonproprietary): brinzolamide
Active ingredients: Brinzolamide — 10 mg/mL
Dosage form: Suspension/ drops
Route: Ophthalmic
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211914
Marketing start: Oct 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 0574-4012_071072b1-f9f8-4267-aa04-848d27e0e902SPL ID 071072b1-f9f8-4267-aa04-848d27e0e902SPL set ID b56a2e4b-7502-4831-a5b1-0370bdb987b1RxCUI 308805UNII 9451Z89515
Pharmacologic class: Carbonic Anhydrase Inhibitor

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

N400574401210 followed by a unit qualifier and the quantity

Package 00574-4012-10. 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 Aug 31, 2024.

Indications (excerpt from the label)

Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-4012

What is NDC 0574-4012?: 0574-4012 is the product NDC for Brinzolamide, Brinzolamide 10 mg/mL suspension/ drops, listed with the FDA by Padagis US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Brinzolamide.
What is the active ingredient?: Brinzolamide.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Brinzolamide?: 4 other product NDCs are listed under this name. See all Brinzolamide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Brinzolamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Brinzolamide	Brinzolamide 10 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	72162-2201	72162-2201-0272162-2201-04
Brinzolamide	Brinzolamide 10 mg/mL	Suspension/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-464	24208-0464-1024208-0464-15
Brinzolamide	Brinzolamide 10 mg/mL	Suspension/ dropsOphthalmic	Oceanside Pharmaceuticals.	68682-464	68682-0464-1068682-0464-15
Brinzolamide	Brinzolamide 10 mg/mL	Suspension/ dropsOphthalmic	Sandoz Inc	0781-6014	00781-6014-7000781-6014-85

Other NDCs under ANDA 211914

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211914
Product	Strength	Form · route	Labeler	Product NDC
Brinzolamide	Brinzolamide 10 mg/mL	Suspension/ dropsOphthalmic	Bryant Ranch Prepack	72162-2201