Brimonidine Tartrate
- Product NDC
- 68083-626
- 11-digit product format
- 680830626
- Labeler code
- 68083
- Product ID
- 68083-626_d45de474-a50b-4bb3-a833-3b163803a9fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brimonidine Tartrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA219219
- Marketing category
- ANDA
- Marketing start
- 2026-03-11
- Substance
- BRIMONIDINE TARTRATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H |
| Rxcui | 861204 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-626-05 | Brimonidine Tartrate | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 6 |
| 68083-626-05 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 68083-626-10 | Brimonidine Tartrate | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 6 |
| 68083-626-10 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 68083-626-15 | Brimonidine Tartrate | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 6 |
| 68083-626-15 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-626-05 | 68083062605 | 1 BOTTLE in 1 CARTON (68083-626-05) / 5 mL in 1 BOTTLE | 1 bottle | 2026-03-11 | No | No | Current |
| 68083-626-10 | 68083062610 | 1 BOTTLE in 1 CARTON (68083-626-10) / 10 mL in 1 BOTTLE | 1 bottle | 2026-03-11 | No | No | Current |
| 68083-626-15 | 68083062615 | 1 BOTTLE in 1 CARTON (68083-626-15) / 15 mL in 1 BOTTLE | 1 bottle | 2026-03-11 | No | No | Current |