Dorzolamide Hydrochloride NDC 72266-197

NDC codes

FDA NDC Directory

Product NDC (as listed)72266-197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72266-0197Add 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
72266-197-01	72266019701	1 BOTTLE in 1 CARTON (72266-197-01) / 10 mL in 1 BOTTLEMarketed from Jan 23, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Dorzolamide Hydrochloride
Generic name (nonproprietary): dorzolamide hydrochloride
Active ingredients: Dorzolamide hydrochloride — 20 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: FOSUN PHARMA USA INC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215660
Marketing start: Jan 23, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 72266-197_3fb5657e-e6e3-066b-e063-6294a90a67abSPL ID 3fb5657e-e6e3-066b-e063-6294a90a67abSPL set ID ef173b63-499f-301b-e053-2995a90a4771RxCUI 310015UNII QZO5366EW7
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

N472266019701 followed by a unit qualifier and the quantity

Package 72266-0197-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 215660

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

FDA NDC Directory listings under ANDA 215660
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	SolutionOphthalmic	Gland Pharma Limited	68083-489
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Sagent Pharmaceuticals	25021-006