NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2184Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2184Add 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
72162-2184-27216221840210 mL in 1 BOTTLE (72162-2184-2)Marketed from Dec 7, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Active ingredients
Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form
Solution
Route
Ophthalmic
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090604
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers
Product ID 72162-2184_2d368eee-4a07-4885-a62d-868ed570e307SPL ID 2d368eee-4a07-4885-a62d-868ed570e307SPL set ID be8b1a47-3342-4072-b67c-6d1374d5d4d6RxCUI 1923432UNII 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

N472162218402 followed by a unit qualifier and the quantity

Package 72162-2184-02. 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)

Dorzolamide hydrochloride and timolol maleate ophthalmic solution 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)]. •Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090604

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

FDA NDC Directory listings under ANDA 090604
ProductStrengthForm · routeLabelerProduct NDC
Dorzolamide Hydrochloride and Timolol MaleateDorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mLSolutionOphthalmicSandoz Inc61314-030

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