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NDC 50742-0323-60 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 Ingenus Pharmaceuticals, 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: 50742-0323-60Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
| NDC | 50742-0323 |
|---|---|
| Product ID | 50742-323_d2b2581d-16f3-468d-b0aa-657747142287 |
| Associated GPIs | |
| 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 |
| 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 | Ingenus Pharmaceuticals, 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 | ANDA217260 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50742-0323-60 (50742032360)
| NDC Package Code | 50742-323-60 |
|---|---|
| Billing NDC | 50742032360 |
| Package | 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL |
| Marketing Start Date | 2023-05-02 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.56842 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DORZOLAMIDE-TIMOLOL 2%-0.5% |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |