Brimonidine tartrate
- Product NDC
- 42571-419
- 11-digit product format
- 425710419
- Labeler code
- 42571
- Product ID
- 42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brimonidine tartrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Micro Labs Limited
- Application
- ANDA217846
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- Substance
- BRIMONIDINE TARTRATE
- Active strength
- 2 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H |
| Rxcui | 861200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-419-56 | Brimonidine tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 42571-419-56 | Brimonidine tartrate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 3 |
| 42571-419-57 | Brimonidine tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 42571-419-57 | Brimonidine tartrate | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 3 |
| 42571-419-92 | Brimonidine tartrate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
| 42571-419-92 | Brimonidine tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-419 | BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [MICRO LABS LIMITED] | 2 | Current NDC, 6 package rows | 20240402_75c5f708-1afb-4505-94a6-a2c0afb0aedc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-419-56 | 42571041956 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPER | 2024-04-01 | No | No | Current |
| 42571-419-57 | 42571041957 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPER | 2024-04-01 | No | No | Current |
| 42571-419-92 | 42571041992 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPER | 2024-04-01 | No | No | Current |