Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
- Product NDC
- 60505-0589
- 11-digit product format
- 605050589
- Labeler code
- 60505
- Product ID
- 60505-0589_afc08ce8-3d89-644d-abdc-61a96ad5d107
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brimonidine Tartrate and Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA091442
- Marketing category
- ANDA
- Marketing start
- 2022-10-19
- Substance
- BRIMONIDINE TARTRATE; TIMOLOL MALEATE
- Active strength
- 2; 5 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 2 mg/mL |
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H, P8Y54F701R |
| Rxcui | 861635 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-0589-1 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
| 60505-0589-1 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 7 |
| 60505-0589-2 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 7 |
| 60505-0589-2 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
| 60505-0589-3 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | | 7 |
| 60505-0589-3 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0589 | BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [APOTEX CORP.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240921_268c3f6b-8798-7987-3b8c-7b7f560af5d7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-0589-1 | 60505058901 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-1) / 5 mL in 1 BOTTLE, DROPPER | 2022-10-19 | 0000-00-00 | No | No | Current |
| 60505-0589-2 | 60505058902 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-2) / 10 mL in 1 BOTTLE, DROPPER | 2022-10-19 | 0000-00-00 | No | No | Current |
| 60505-0589-3 | 60505058903 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0589-3) / 15 mL in 1 BOTTLE, DROPPER | 2022-10-19 | 0000-00-00 | No | No | Current |