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NDC 65862-0947-18 Dorzolamide Hydrochloride and Timolol Maleate Preservative Free 20; 5 mg/mL; mg/mL Details
Dorzolamide Hydrochloride and Timolol Maleate Preservative Free 20; 5 mg/mL; mg/mL
Dorzolamide Hydrochloride and Timolol Maleate Preservative Free is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma 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: 65862-0947-18Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
| NDC | 65862-0947 |
|---|---|
| Product ID | 65862-947_fd6c28a4-40df-487d-abe5-e71744941af1 |
| 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 Preservative Free |
| 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 | Aurobindo Pharma 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 | ANDA207630 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0947-18 (65862094718)
| NDC Package Code | 65862-947-18 |
|---|---|
| Billing NDC | 65862094718 |
| Package | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2018-07-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |