Prescription drug · ANDA
Dorzolamide and Timolol NDC 69315-305
dorzolamide hydrochloride and timolol maleate ophthalmic solution · Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution · Ophthalmic · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-305-05 | 69315030505 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from May 18, 2017 | |
| 69315-305-10 | 69315030510 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from May 18, 2017 |
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 and Timolol
- Generic name (nonproprietary)
- dorzolamide hydrochloride and timolol maleate ophthalmic solution
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Leading Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205295
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3SPL ID bb4ef754-0b95-4c0e-8131-7a81dc4f33d3SPL set ID c9ae08c5-275d-44b3-9d1e-5d8fedc21b96RxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0369315305058, 0369315305102
- 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
N469315030505followed by a unit qualifier and the quantityPackage 69315-0305-05. 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)
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor and timolol maleate, a beta-adrenergic receptor blocking agent 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. The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. ( 1 ) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indic…
Excerpt only. Read the full label for complete information.