What is NDC 82584-604?

82584-604 is the product NDC for Cosopt PF, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Thea Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Cosopt PF (Dorzolamide hydrochloride and timolol maleate).

What is the active ingredient?

Dorzolamide hydrochloride, Timolol maleate.

Thea Pharma Inc., NDC labeler code 82584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cosopt PF?

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.

Cosopt PF NDC 82584-604 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82584-604Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82584-0604Add 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
82584-604-30	8258406043082584060430	4 POUCH in 1 CARTON (82584-604-30) / 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) / .2 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 10, 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): Cosopt PF
Generic name (nonproprietary): dorzolamide hydrochloride and timolol maleate
Active ingredients: Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Thea Pharma Inc.NDC labeler code 82584
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202667
Marketing start: Dec 10, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 82584-604_51b818ee-6194-a845-e063-6394a90ae44bSPL ID 51b818ee-6194-a845-e063-6394a90ae44bSPL set ID 535fc801-8c3f-4974-a120-3eff1d5a5062RxCUI 1922783, 1922784UNII 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

N482584060430 followed by a unit qualifier and the quantity

Package 82584-0604-30. 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 13, 2026.

Indications (excerpt from the label)

COSOPT® PF 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 COSOPT® 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) ]. • COSOPT PF is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor inhibitor, indicated for the reduction of e…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82584-604

What is NDC 82584-604?: 82584-604 is the product NDC for Cosopt PF, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Thea Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cosopt PF (Dorzolamide hydrochloride and timolol maleate).
What is the active ingredient?: Dorzolamide hydrochloride, Timolol maleate.
Who is the labeler?: Thea Pharma Inc., NDC labeler code 82584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cosopt PF?: 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 NDA 202667

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

FDA NDC Directory listings under NDA 202667
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Akorn	50383-261