TIMOLOL MALEATE
- Product NDC
- 59651-313
- 11-digit product format
- 596510313
- Labeler code
- 59651
- Product ID
- 59651-313_a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TIMOLOL MALEATE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213540
- Marketing category
- ANDA
- Marketing start
- 2023-03-23
- 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 | 313408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-313-05 | TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 59651-313-05 | TIMOLOL MALEATE | 5 mL in 1 BOTTLE, DISPENSING | SOLUTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-313 | TIMOLOL MALEATE SOLUTION [AUROBINDO PHARMA LIMITED] | 4 | Current NDC, 2 package rows | 20240518_e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-313-05 | 59651031305 | 1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSING | 2023-03-23 | No | No | Current |