Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%
- Product NDC
- 62332-545
- 11-digit product format
- 623320545
- Labeler code
- 62332
- Product ID
- 62332-545_23d94ead-288f-4771-983c-7cf04363976a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA212942
- Marketing category
- ANDA
- Marketing start
- 2020-11-22
- Substance
- TIMOLOL MALEATE
- Active strength
- 2.5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 313408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-545-05 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 5 |
| 62332-545-05 | Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-545 | TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250427_b909ecf0-c90a-4719-a144-9e74f457cb87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-545-05 | 62332054505 | 1 BOTTLE in 1 CARTON (62332-545-05) / 5 mL in 1 BOTTLE | 1 bottle | 2020-11-22 | 0000-00-00 | No | No | Current |