Brimonidine Tartrate ophthalmic solution, 0.15%
- Product NDC
- 46708-661
- 11-digit product format
- 467080661
- Labeler code
- 46708
- Product ID
- 46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brimonidine Tartrate ophthalmic solution, 0.15%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215225
- Marketing category
- ANDA
- Marketing start
- 2023-03-29
- Substance
- BRIMONIDINE TARTRATE
- Active strength
- 1.5 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brimonidine Tartrate ophthalmic solution, 0.15%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 1.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H |
| Rxcui | 861208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-661-05 | Brimonidine Tartrate ophthalmic solution, 0.15% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-661-05 | Brimonidine Tartrate ophthalmic solution, 0.15% | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 46708-661-10 | Brimonidine Tartrate ophthalmic solution, 0.15% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-661-10 | Brimonidine Tartrate ophthalmic solution, 0.15% | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 1 |
| 46708-661-15 | Brimonidine Tartrate ophthalmic solution, 0.15% | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | | 1 |
| 46708-661-15 | Brimonidine Tartrate ophthalmic solution, 0.15% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-661 | BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 6 package rows | 20230707_e1ea003e-3dd9-41c7-9119-d1f209b9820b.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 |
|---|
| 46708-661-05 | 46708066105 | 1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLE | 1 bottle | 2023-03-29 | No | No | Historical |
| 46708-661-10 | 46708066110 | 1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLE | 1 bottle | 2023-03-29 | No | No | Historical |
| 46708-661-15 | 46708066115 | 1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLE | 1 bottle | 2023-03-29 | No | No | Historical |