Prescription drug · ANDA
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE NDC 70069-051
Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-051-01 | 70069005101 | 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLEMarketed from Jun 25, 2019 |
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
- Generic name (nonproprietary)
- dorzolamide hydrochloride and timolol maleate
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207523
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 70069-051_81a3be92-0fdb-46c8-bc20-cd0947a2dbdfSPL ID 81a3be92-0fdb-46c8-bc20-cd0947a2dbdfSPL set ID 17f04726-725f-4839-911d-47fc5e02baaeRxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0370069051016
- 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
N470069005101followed by a unit qualifier and the quantityPackage 70069-0051-01. 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 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)] . Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a …
Excerpt only. Read the full label for complete information.