paroxetine

Generic: paroxetine

Labeler: solco healthcare llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler solco healthcare llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

paroxetine mesylate 7.5 mg/1

Manufacturer
Solco Healthcare LLC

Identifiers & Regulatory

Product NDC 43547-409
Product ID 43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207188
Listing Expiration 2027-12-31
Marketing Start 2017-08-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547409
Hyphenated Format 43547-409

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 ANDA207188 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (43547-409-03)
source: ndc

Packages (1)

43547-409-03 30 CAPSULE in 1 BOTTLE (43547-409-03)

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": "30b0c2b9-fb81-4015-ad28-12e658de0dea", "openfda": {"unii": ["M711N184JE"], "rxcui": ["1430122"], "spl_set_id": ["2c5836c3-2099-452e-b6af-d2d50dc359fd"], "manufacturer_name": ["Solco Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43547-409-03)", "package_ndc": "43547-409-03", "marketing_start_date": "20170815"}], "brand_name": "PAROXETINE", "product_id": "43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43547-409", "generic_name": "paroxetine", "labeler_name": "Solco Healthcare LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE MESYLATE", "strength": "7.5 mg/1"}], "application_number": "ANDA207188", "marketing_category": "ANDA", "marketing_start_date": "20170815", "listing_expiration_date": "20271231"}