Dorzolamide Hydrochloride And Timolol Maleate NDC 42571-382

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-382Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0382Add 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
42571-382-27	42571038227	12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 2022
42571-382-73	42571038273	4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 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 And Timolol Maleate
Generic name (nonproprietary): dorzolamide hydrochloride and timolol maleate preservative free
Active ingredients: Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215936
Marketing start: Feb 15, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 42571-382_50aa565b-e11f-8176-e063-6294a90ab0b5SPL ID 50aa565b-e11f-8176-e063-6294a90ab0b5SPL set ID b0a1d984-efee-4751-9797-c09adc2d307dRxCUI 1922783UNII QZO5366EW7, P8Y54F701R
Pharmacologic class: Carbonic Anhydrase Inhibitor; beta-Adrenergic Blocker

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

N442571038227 followed by a unit qualifier and the quantity

Package 42571-0382-27. 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 Apr 30, 2026.

Indications (excerpt from the label)

Dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1) ]. Dorzolamide hydrochloride and timolol maleate ophth…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)