timolol maleate ophthalmic gel forming solution
- Product NDC
- 68083-458
- 11-digit product format
- 680830458
- Labeler code
- 68083
- Product ID
- 68083-458_0c73f98d-4f49-415a-abc5-2d253061e669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate ophthalmic gel forming
- Dosage form
- SOLUTION, GEL FORMING / DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA214645
- Marketing category
- ANDA
- Marketing start
- 2023-02-14
- Substance
- TIMOLOL MALEATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P8Y54F701R | TIMOLOL MALEATE | 26921-17-5 | TIMOLOL MALEATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-458-01 | 68083045801 | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE | 1 bottle | 2023-02-14 | No | No | Historical |