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NDC 65862-0947-60 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: 65862-0947-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dorzolamide and Timolol Ophthalmic
Product Information
NDC | 65862-0947 |
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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 65862-0947-60 (65862094760)
NDC Package Code | 65862-947-60 |
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Billing NDC | 65862094760 |
Package | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE |
Marketing Start Date | 2018-07-24 |
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 |