paroxetine

Generic: paroxetine

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler padagis us llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

paroxetine mesylate 7.5 mg/1

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-0279
Product ID 0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA204516
Listing Expiration 2026-12-31
Marketing Start 2017-10-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05740279
Hyphenated Format 0574-0279

Supplemental Identifiers

RxCUI
1430122
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 paroxetine (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 BOTTLE (0574-0279-30)
source: ndc

Packages (1)

0574-0279-30 30 CAPSULE in 1 BOTTLE (0574-0279-30)

Ingredients (1)

paroxetine mesylate (7.5 mg/1)

Linked Drug Pages (1)

Paroxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd", "openfda": {"unii": ["M711N184JE"], "rxcui": ["1430122"], "spl_set_id": ["1383d713-79b9-45bd-bd06-65707f28bc99"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0574-0279-30)", "package_ndc": "0574-0279-30", "marketing_start_date": "20171003"}], "brand_name": "Paroxetine", "product_id": "0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0574-0279", "generic_name": "paroxetine", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE MESYLATE", "strength": "7.5 mg/1"}], "application_number": "NDA204516", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20171003", "listing_expiration_date": "20261231"}