NDC 61314-030

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-030Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0030Add 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
61314-030-01	61314003001	5 mL in 1 BOTTLE (61314-030-01)Marketed from Jan 2, 2010
61314-030-02	61314003002	10 mL in 1 BOTTLE (61314-030-02)Marketed from Jan 2, 2010

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
Active ingredients: Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090604
Marketing start: Jan 2, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 61314-030_81902bf8-eb10-4ce2-8d1e-b32ba04adf6aSPL ID 81902bf8-eb10-4ce2-8d1e-b32ba04adf6aSPL set ID 78f39126-3e3b-4633-a4e0-c1f09a794eecRxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0361314030023
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

N461314003001 followed by a unit qualifier and the quantity

Package 61314-0030-01. 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 31, 2021.

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…

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
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL	SolutionOphthalmic	Bryant Ranch Prepack	72162-2184

Dorzolamide Hydrochloride and Timolol Maleate NDC 61314-030