Timolol maleate
- Product NDC
- 70069-703
- 11-digit product format
- 700690703
- Labeler code
- 70069
- Product ID
- 70069-703_e37dc12f-1930-43d0-87a5-ae1eebff29f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA217764
- Marketing category
- ANDA
- Marketing start
- 2024-07-04
- 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
- 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 | 1923428, 1992303 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-703-01 | Timolol maleate | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 2 |
| 70069-703-01 | Timolol maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-703 | TIMOLOL MALEATE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 2 | Current NDC, 2 package rows | 20240705_5d60db57-ca24-4cab-a90d-8cf06992a34e.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 |
|---|
| 70069-703-01 | 70069070301 | 1 BOTTLE in 1 CARTON (70069-703-01) / 15 mL in 1 BOTTLE | 1 bottle | 2024-07-04 | No | No | Historical |