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NDC 69315-0305-05 Dorzolamide and Timolol 20; 5 mg/mL; mg/mL Details
Dorzolamide and Timolol 20; 5 mg/mL; mg/mL
Dorzolamide and Timolol is a OPHTHALMIC SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. The primary component is DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE.
MedlinePlus Drug Summary
The combination of dorzolamide and timolol is used to treat eye conditions, including glaucoma and ocular hypertension, in which increased pressure can lead to a gradual loss of vision. Dorzolamide and timolol is used for patients whose eye condition has not responded to another medication. Dorzolamide is in a class of medications called topical carbonic anhydrase inhibitors. Timolol is in a class of medications called topical beta blockers. Dorzolamide and timolol lowers pressure in the eye by decreasing the production of natural fluids in the eye.
Related Packages: 69315-0305-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
| NDC | 69315-0305 |
|---|---|
| Product ID | 69315-305_be87baf2-ac60-4540-8cf2-1d6be01acff8 |
| Associated GPIs | 86259902202020 |
| GCN Sequence Number | 039531 |
| GCN Sequence Number Description | dorzolamide HCl/timolol maleat DROPS 22.3-6.8/1 OPHTHALMIC |
| HIC3 | Q6G |
| HIC3 Description | MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS |
| GCN | 95919 |
| HICL Sequence Number | 018269 |
| HICL Sequence Number Description | DORZOLAMIDE HCL/TIMOLOL MALEATE |
| Brand/Generic | Generic |
| Proprietary Name | Dorzolamide and Timolol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 20; 5 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
| Labeler Name | Leading Pharma, LLC |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205295 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69315-0305-05 (69315030505)
| NDC Package Code | 69315-305-05 |
|---|---|
| Billing NDC | 69315030505 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2017-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |