Dorzolamide Hydrochloride NDC 68083-489

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-489Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0489Add 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
68083-489-01	68083048901	1 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLEMarketed from Jan 27, 2022

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: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215660
Marketing start: Jan 27, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 68083-489_97a5fb1e-bdb1-43f9-8419-4b12d36d429cSPL ID 97a5fb1e-bdb1-43f9-8419-4b12d36d429cSPL set ID 2023e603-12bb-4502-9f93-0126e0cc24edRxCUI 310015UNII QZO5366EW7UPC 0368083489014
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

N468083048901 followed by a unit qualifier and the quantity

Package 68083-0489-01. 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

Current FDA label (SPL), effective May 10, 2025.

Indications (excerpt from the label)

Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure 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)

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	FOSUN PHARMA USA INC	72266-197
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Sagent Pharmaceuticals	25021-006