brisdelle

Generic: paroxetine

Labeler: legacy pharma usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name brisdelle
Generic Name paroxetine
Labeler legacy pharma usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

paroxetine mesylate 7.5 mg/1

Manufacturer
Legacy Pharma USA, Inc.

Identifiers & Regulatory

Product NDC 83107-027
Product ID 83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204516
Listing Expiration 2026-12-31
Marketing Start 2025-02-18

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83107027
Hyphenated Format 83107-027

Supplemental Identifiers

RxCUI
1430122 1430128
UNII
M711N184JE

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brisdelle (source: ndc)
Generic Name paroxetine (source: ndc)
Application Number NDA204516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (83107-027-30)
source: ndc

Packages (1)

83107-027-30 30 CAPSULE in 1 BLISTER PACK (83107-027-30)

Ingredients (1)

paroxetine mesylate (7.5 mg/1)

Linked Drug Pages (1)

BRISDELLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a33eb37f-c69b-41f3-9d18-540bfd226aa6", "openfda": {"unii": ["M711N184JE"], "rxcui": ["1430122", "1430128"], "spl_set_id": ["502311b3-b617-4cbd-a3ab-a60f2c62880a"], "manufacturer_name": ["Legacy Pharma USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (83107-027-30)", "package_ndc": "83107-027-30", "marketing_start_date": "20250218"}], "brand_name": "BRISDELLE", "product_id": "83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "83107-027", "generic_name": "paroxetine", "labeler_name": "Legacy Pharma USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BRISDELLE", "active_ingredients": [{"name": "PAROXETINE MESYLATE", "strength": "7.5 mg/1"}], "application_number": "NDA204516", "marketing_category": "NDA", "marketing_start_date": "20250218", "listing_expiration_date": "20261231"}