What is NDC 14445-405?

14445-405 is the product NDC for Dorzolamide Hydrochloride Timolol Maletae, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Indoco Remedies Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Dorzolamide Hydrochloride Timolol Maletae (Ddorzolamide hydrochloride timolol maleate).

What is the active ingredient?

Dorzolamide hydrochloride, Timolol maleate.

Indoco Remedies Limited, NDC labeler code 14445. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dorzolamide Hydrochloride Timolol Maletae?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 14445-405

NDC codes

FDA NDC Directory

Product NDC (as listed)14445-405Labeler and product segments. Claims need a package NDC.

Product NDC at billing width14445-0405Add 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
14445-405-10	1444504051014445040510	1 BOTTLE, DISPENSING in 1 CARTON (14445-405-10) / 10 mL in 1 BOTTLE, DISPENSINGMarketed from May 14, 2021

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 Timolol Maletae
Generic name (nonproprietary): ddorzolamide hydrochloride timolol maleate
Active ingredients: Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Indoco Remedies LimitedNDC labeler code 14445
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202054
Marketing start: May 14, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 14445-405_930864c1-40f8-45ea-aa4f-c158b3d9f53dSPL ID 930864c1-40f8-45ea-aa4f-c158b3d9f53dSPL set ID 0b75a79a-e048-4bf1-b02b-a72a8b8a0b3bRxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0314445405109
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

N414445040510 followed by a unit qualifier and the quantity

Package 14445-0405-10. 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 Dec 22, 2025.

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 c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 14445-405

What is NDC 14445-405?: 14445-405 is the product NDC for Dorzolamide Hydrochloride Timolol Maletae, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Indoco Remedies Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dorzolamide Hydrochloride Timolol Maletae (Ddorzolamide hydrochloride timolol maleate).
What is the active ingredient?: Dorzolamide hydrochloride, Timolol maleate.
Who is the labeler?: Indoco Remedies Limited, NDC labeler code 14445. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dorzolamide Hydrochloride Timolol Maletae?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 202054

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

FDA NDC Directory listings under ANDA 202054
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloride Timolol Maleate	Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Florida Pharmaceutical Products, LLC	71921-226

Dorzolamide Hydrochloride Timolol Maletae NDC 14445-405