Search by Drug Name or NDC
NDC 69315-0305-10 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: 69315-0305-10Last 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 69315-0305-10 (69315030510)
NDC Package Code | 69315-305-10 |
---|---|
Billing NDC | 69315030510 |
Package | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC |
Marketing Start Date | 2017-05-18 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1.04286 |
Pricing Unit | ML |
Effective Date | 2024-02-21 |
NDC Description | DORZOLAMIDE-TIMOLOL EYE DROPS |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |