Prescription drug · ANDA
Dorzolamide Hydrochloride and Timolol Maleate Preservative Free NDC 65862-947
Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-947-18 | 65862094718 | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USEMarketed from Jul 24, 2018 | |
| 65862-947-60 | 65862094760 | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USEMarketed from Jul 24, 2018 |
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 and Timolol Maleate Preservative Free
- Generic name (nonproprietary)
- dorzolamide hydrochloride and timolol maleate preservative free
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207630
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-947_b02840eb-1403-4b25-b7a9-4484edfa0a50SPL ID b02840eb-1403-4b25-b7a9-4484edfa0a50SPL set ID f41a9cd5-48c8-42eb-bb1b-d0355d981201RxCUI 1922783UNII QZO5366EW7, P8Y54F701RUPC 0365862947154, 0365862947185
- 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
N465862094718followed by a unit qualifier and the quantityPackage 65862-0947-18. 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 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 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 (14.1) ]. Dorzolamide hydrochloride and timolol maleate ophth…
Excerpt only. Read the full label for complete information.