Timolol Maleate
- Product NDC
- 0378-0221
- 11-digit product format
- 003780221
- Labeler code
- 0378
- Product ID
- 0378-0221_30d62085-4192-46af-b05a-da3eed7d1fc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA072668
- Marketing category
- ANDA
- Marketing start
- 1990-06-08
- Marketing end
- 2027-03-31
- Substance
- TIMOLOL MALEATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Timolol Maleate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 198284, 198285, 198286 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0221-01 | Timolol Maleate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0221 | TIMOLOL MALEATE TABLET [MYLAN PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20250522_57c62928-63d8-4505-9b9e-c085a3a12c95.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 |
|---|
| 0378-0221-01 | 00378022101 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01) | 100 tablet | 1990-06-08 | 2027-03-31 | No | No | Current |