Timolol Maleate
- Product NDC
- 16571-223
- 11-digit product format
- 165710223
- Labeler code
- 16571
- Product ID
- 16571-223_ebb620d8-8e2e-4632-b8a8-74f41c9969e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207556
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- Substance
- TIMOLOL MALEATE
- Active strength
- 5 mg/1
- 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/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 |
|---|
| 16571-223-01 | Timolol Maleate | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-223 | TIMOLOL MALEATE TABLET [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 1 package rows | 20241212_0bc40b2c-65eb-4095-87e6-4752d5b19a3a.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 |
|---|
| 16571-223-01 | 16571022301 | 100 TABLET in 1 BOTTLE (16571-223-01) | 100 tablet | 2024-12-10 | No | No | Current |