Timolol Maleate
- Product NDC
- 70069-251
- 11-digit product format
- 700690251
- Labeler code
- 70069
- Product ID
- 70069-251_a7b2ec00-1f4a-4058-a397-82d028d8476c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION, GEL FORMING / DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA210640
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- 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 | 313407, 313408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-251-01 | Timolol Maleate | 5 mL in 1 BOTTLE | SOLUTION, GEL FORMING / DROPS | 5 | | 6 |
| 70069-251-01 | Timolol Maleate | 1 in 1 CARTON | SOLUTION, GEL FORMING / DROPS | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-251 | TIMOLOL MALEATE SOLUTION, GEL FORMING / DROPS [SOMERSET THERAPEUTICS, LLC] | 6 | Current NDC, 2 package rows | 20241106_e797f7c7-0588-4627-b060-8df6bcfe3f7b.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 |
|---|
| 70069-251-01 | 70069025101 | 1 BOTTLE in 1 CARTON (70069-251-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-10-31 | No | No | Current |