BRIMONIDINE
- Product NDC
- 45802-078
- 11-digit product format
- 458020078
- Labeler code
- 45802
- Product ID
- 45802-078_6d6fa6f0-e1c6-4ea1-a4fb-8ad511a95d75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brimonidine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA209158
- Marketing category
- ANDA
- Marketing start
- 2023-01-01
- Substance
- BRIMONIDINE TARTRATE
- Active strength
- 5 mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BRIMONIDINE TARTRATE | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4S9CL2DY2H |
| Rxcui | 1437707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-078-30 | BRIMONIDINE | 1 in 1 CARTON | GEL | 1 | | 4 |
| 45802-078-30 | BRIMONIDINE | 30 g in 1 BOTTLE, PUMP | GEL | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-078 | BRIMONIDINE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230101_c899b329-cc5e-4443-8e94-451314de47c9.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 |
|---|
| 45802-078-30 | 45802007830 | 1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP | 2023-01-01 | 0000-00-00 | No | No | Current |