Prescription drug · NDA
Cosopt NDC 82584-605
dorzolamide hydrochloride and timolol maleate · Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82584-605-10 | 82584060510 | 1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Nov 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
- 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.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020869
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 82584-605_164c0ca8-87af-0887-e063-6294a90a5ec7SPL ID 164c0ca8-87af-0887-e063-6294a90a5ec7SPL set ID 23bdf1c1-3134-4ad1-8e7c-bc655156bdc6RxCUI 1923432, 1923433UNII QZO5366EW7, P8Y54F701RUPC 0382584605100
- 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
N482584060510followed by a unit qualifier and the quantityPackage 82584-0605-10. 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 .
Indications (excerpt from the label)
COSOPT ® 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) ] . COSOPT is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of eleva…
Excerpt only. Read the full label for complete information.