Search by Drug Name or NDC
NDC 42571-0398-71 Timolol Maleate 6.8 mg/mL Details
Timolol Maleate 6.8 mg/mL
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 TIMOLOL MALEATE.
Product Information
| NDC | 42571-0398 |
|---|---|
| Product ID | 42571-398_e83cac2d-dac4-b4d0-e053-2a95a90acbd8 |
| Associated GPIs | |
| GCN Sequence Number | 030007 |
| GCN Sequence Number Description | timolol maleate/PF DROPERETTE 0.5 % OPHTHALMIC |
| HIC3 | Q6G |
| HIC3 Description | MIOTICS AND OTHER INTRAOCULAR PRESSURE REDUCERS |
| GCN | 32826 |
| HICL Sequence Number | 036505 |
| HICL Sequence Number Description | TIMOLOL MALEATE/PF |
| Brand/Generic | Generic |
| Proprietary Name | Timolol Maleate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Timolol Maleate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 6.8 |
| Active Ingredient Units | mg/mL |
| Substance Name | TIMOLOL MALEATE |
| Labeler Name | Micro Labs Limited |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216596 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0398-71 (42571039871)
| NDC Package Code | 42571-398-71 |
|---|---|
| Billing NDC | 42571039871 |
| Package | 6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL |
| Marketing Start Date | 2023-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |