Brimonidine Tartrate
- Product NDC
- 60505-0564
- 11-digit product format
- 605050564
- Labeler code
- 60505
- Product ID
- 60505-0564_5832760f-7397-35f8-6aa8-abdaebbe657a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brimonidine tartrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA078479
- Marketing category
- ANDA
- Marketing start
- 2022-01-31
- 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
- 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 |
|---|
| 60505-0564-1 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 60505-0564-1 | Brimonidine Tartrate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 7 |
| 60505-0564-2 | Brimonidine Tartrate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 7 |
| 60505-0564-2 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 60505-0564-3 | Brimonidine Tartrate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 60505-0564-3 | Brimonidine Tartrate | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0564 | BRIMONIDINE TARTRATE SOLUTION/ DROPS [APOTEX CORP.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240921_64b21e68-610c-5194-ccb2-9d9f6ff8cda9.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 |
|---|
| 60505-0564-1 | 60505056401 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER | 2022-01-31 | 0000-00-00 | No | No | Current |
| 60505-0564-2 | 60505056402 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2) / 10 mL in 1 BOTTLE, DROPPER | 2022-03-14 | 0000-00-00 | No | No | Current |
| 60505-0564-3 | 60505056403 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3) / 15 mL in 1 BOTTLE, DROPPER | 2022-01-31 | 0000-00-00 | No | No | Current |