Timolol Hemihydrate
- Product NDC
- 70069-697
- 11-digit product format
- 700690697
- Labeler code
- 70069
- Product ID
- 70069-697_c1213979-d6ff-44c2-ad97-1de99ddcf8d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Hemihydrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA216654
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- Substance
- TIMOLOL ANHYDROUS
- 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 Hemihydrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL ANHYDROUS | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5JKY92S7BR |
| Rxcui | 2702393 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-697-01 | Timolol Hemihydrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 70069-697-01 | Timolol Hemihydrate | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-697 | TIMOLOL HEMIHYDRATE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 3 | Current NDC, 2 package rows | 20241106_cebc9a5e-0bdb-4f23-9b2c-cde543b62fb6.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 |
|---|
| 70069-697-01 | 70069069701 | 1 BOTTLE in 1 CARTON (70069-697-01) / 10 mL in 1 BOTTLE | 1 bottle | 2024-10-31 | No | No | Current |