Prescription drug · NDA
Dorzolamide Hydrochloride and Timolol Maleate NDC 50383-261
Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Akorn
NDC codes
FDA NDC DirectoryProduct 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/ drops
- Route
- Ophthalmic
- Labeler
- Akorn
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202667
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59dSPL ID 5c6a634a-b5ed-417d-b4b9-bc389538f59dSPL set ID 4e90c721-21e8-46ea-ab49-19f535bf7202RxCUI 1922783UNII 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) 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-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 (14.1) ] . • Dorzolamide hydrochloride-timolol maleate ophthalmic s…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202667
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cosopt PFdorzolamide hydrochloride and timolol maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Thea Pharma Inc. | 82584-604 |