Timolol Maleate
- Product NDC
- 42571-398
- 11-digit product format
- 425710398
- Labeler code
- 42571
- Product ID
- 42571-398_2882b434-4502-6a6e-e063-6394a90af575
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Micro Labs Limited
- Application
- ANDA216596
- Marketing category
- ANDA
- Marketing start
- 2023-01-01
- Substance
- TIMOLOL MALEATE
- Active strength
- 6.8 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 | 6.8 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 1922894 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-398-71 | Timolol Maleate | 6 in 1 CARTON | SOLUTION/ DROPS | 6 | | 2 |
| 42571-398-71 | Timolol Maleate | 10 in 1 POUCH | SOLUTION/ DROPS | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-398 | TIMOLOL MALEATE SOLUTION/ DROPS [MICRO LABS LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241207_79b223e4-d929-4667-8149-e79bfab13fdf.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 |
|---|
| 42571-398-71 | 42571039871 | 6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL | 6 pouch | 2023-01-01 | 0000-00-00 | No | No | Current |