BRISDELLE
- Product NDC
- 83107-027
- 11-digit product format
- 831070027
- Labeler code
- 83107
- Product ID
- 83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Legacy Pharma USA, Inc.
- Application
- NDA204516
- Marketing category
- NDA
- Marketing start
- 2025-02-18
- Substance
- PAROXETINE MESYLATE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRISDELLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE MESYLATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M711N184JE |
| Rxcui | 1430122, 1430128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83107-027-30 | BRISDELLE | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83107-027 | BRISDELLE (PAROXETINE) CAPSULE [LEGACY PHARMA USA, INC.] | 2 | Current NDC, 1 package rows | 20250504_502311b3-b617-4cbd-a3ab-a60f2c62880a.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 |
|---|
| 83107-027-30 | 83107002730 | 30 CAPSULE in 1 BLISTER PACK (83107-027-30) | 30 capsule | 2025-02-18 | No | No | Current |