Timolol Maleate
- Product NDC
- 65145-152
- 11-digit product format
- 651450152
- Labeler code
- 65145
- Product ID
- 65145-152_4847f180-45e6-40f0-ae8c-6cc500cb0add
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Caplin Steriles Limited
- Application
- ANDA218460
- Marketing category
- ANDA
- Marketing start
- 2024-09-16
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Timolol Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 1992303 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-152-01 | Timolol Maleate | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 1 |
| 65145-152-01 | Timolol Maleate | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-152 | TIMOLOL MALEATE SOLUTION [CAPLIN STERILES LIMITED] | 1 | Current NDC, 2 package rows | 20240917_4847f180-45e6-40f0-ae8c-6cc500cb0add.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-152-01 | 65145015201 | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-09-16 | No | No | Historical |