paroxetine

Generic: paroxetine hydrochloride hemihydrate

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

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler solco healthcare us, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-347
Product ID 43547-347_48f30016-3f81-4060-887c-6eaf14f17c1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2022-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547347
Hyphenated Format 43547-347

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0343547350031 0343547348038 0343547347031 0343547349035
UNII
X2ELS050D8

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 hydrochloride hemihydrate (source: ndc)
Application Number ANDA203854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (43547-347-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43547-347-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (43547-347-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43547-347-50)
source: ndc

Packages (4)

43547-347-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-347-03) 43547-347-09 90 TABLET, FILM COATED in 1 BOTTLE (43547-347-09) 43547-347-11 1000 TABLET, FILM COATED in 1 BOTTLE (43547-347-11) 43547-347-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-347-50)

Ingredients (1)

paroxetine hydrochloride hemihydrate (10 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": "48f30016-3f81-4060-887c-6eaf14f17c1c", "openfda": {"upc": ["0343547350031", "0343547348038", "0343547347031", "0343547349035"], "unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["6cfde064-ddcb-49df-a53c-953c40eb1470"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43547-347-03)", "package_ndc": "43547-347-03", "marketing_start_date": "20220329"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43547-347-09)", "package_ndc": "43547-347-09", "marketing_start_date": "20220329"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (43547-347-11)", "package_ndc": "43547-347-11", "marketing_start_date": "20220329"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43547-347-50)", "package_ndc": "43547-347-50", "marketing_start_date": "20220329"}], "brand_name": "Paroxetine", "product_id": "43547-347_48f30016-3f81-4060-887c-6eaf14f17c1c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43547-347", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20220329", "listing_expiration_date": "20261231"}