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NDC 42571-0382-27 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/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Micro Labs Limited. 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: 42571-0382-27Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
| NDC | 42571-0382 |
|---|---|
| Product ID | 42571-382_0650384a-621f-6c0c-e063-6294a90a82f7 |
| Associated GPIs | 86259902202060 |
| GCN Sequence Number | 061877 |
| GCN Sequence Number Description | dorzolamide/timolol/PF DROPERETTE 2 %-0.5 % OPHTHALMIC |
| HIC3 | Q6G |
| HIC3 Description | MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS |
| GCN | 97662 |
| HICL Sequence Number | 034283 |
| HICL Sequence Number Description | DORZOLAMIDE HCL/TIMOLOL MALEATE/PF |
| Brand/Generic | Generic |
| Proprietary Name | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 20; 5 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
| Labeler Name | Micro Labs Limited |
| 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 | ANDA215936 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0382-27 (42571038227)
| NDC Package Code | 42571-382-27 |
|---|---|
| Billing NDC | 42571038227 |
| Package | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2022-03-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |