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NDC 70069-0051-12 DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Details
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE 20; 5 mg/mL; mg/mL
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE is a OPHTHALMIC SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Somerset Therapeutics, 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: 70069-0051-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
NDC | 70069-0051 |
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Product ID | 70069-051_3acff60b-3a7a-4b15-8d13-950b9cd77f81 |
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 HYDROCHLORIDE and TIMOLOL MALEATE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE |
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 | Somerset Therapeutics, 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 | ANDA207523 |
Listing Certified Through | 2024-12-31 |
Package
NDC 70069-0051-12 (70069005112)
NDC Package Code | 70069-051-12 |
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Billing NDC | 70069005112 |
Package | 12 CARTON in 1 BOX (70069-051-12) / 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE |
Marketing Start Date | 2019-06-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |