timolol maleate
- Product NDC
- 70756-657
- 11-digit product format
- 707560657
- Labeler code
- 70756
- Product ID
- 70756-657_c1bf2590-7a5a-4213-909c-d843fdb72e08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA078771
- Marketing category
- ANDA
- Marketing start
- 2023-06-26
- 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 | 1923428, 1992303 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70756-657-30 | timolol maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 70756-657-30 | timolol maleate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-657 | TIMOLOL MALEATE SOLUTION/ DROPS [LIFESTAR PHARMA LLC] | 2 | Current NDC, 2 package rows | 20230706_545b7bee-8d5d-4206-b973-8de3c14d6dfe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70756-657-30 | 70756065730 | 1 BOTTLE, DROPPER in 1 CARTON (70756-657-30) / 10 mL in 1 BOTTLE, DROPPER | 2023-06-26 | No | No | Historical |