Dorzolamide Hydrochloride and Timolol Maleate
- Product NDC
- 65862-946
- 11-digit product format
- 658620946
- Labeler code
- 65862
- Product ID
- 65862-946_ce99a7ff-3420-478f-90b8-cde6238f158a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride and Timolol Maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207629
- Marketing category
- ANDA
- Marketing start
- 2021-05-14
- Substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Active strength
- 20; 5 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QZO5366EW7 | DORZOLAMIDE HYDROCHLORIDE | 130693-82-2 | DORZOLAMIDE HYDROCHLORIDE |
| P8Y54F701R | TIMOLOL MALEATE | 26921-17-5 | TIMOLOL MALEATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65862-946-01 | 65862094601 | 1 BOTTLE, DROPPER in 1 CARTON (65862-946-01) / 10 mL in 1 BOTTLE, DROPPER | 2021-05-14 | No | No | Historical |