paroxetine

Generic: paroxetine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-181
Product ID 16714-181_0e3542cb-82a1-4a53-b814-55cfa4075ba6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078406
Listing Expiration 2026-12-31
Marketing Start 2007-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714181
Hyphenated Format 16714-181

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
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 (source: ndc)
Application Number ANDA078406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-181-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16714-181-02)
  • 100 TABLET, FILM COATED in 1 BOTTLE (16714-181-03)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16714-181-04)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16714-181-05)
source: ndc

Packages (5)

16714-181-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-181-01) 16714-181-02 90 TABLET, FILM COATED in 1 BOTTLE (16714-181-02) 16714-181-03 100 TABLET, FILM COATED in 1 BOTTLE (16714-181-03) 16714-181-04 500 TABLET, FILM COATED in 1 BOTTLE (16714-181-04) 16714-181-05 1000 TABLET, FILM COATED in 1 BOTTLE (16714-181-05)

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": "0e3542cb-82a1-4a53-b814-55cfa4075ba6", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["118320de-0632-4139-8b13-7428b41da0ac"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-181-01)", "package_ndc": "16714-181-01", "marketing_start_date": "20070725"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-181-02)", "package_ndc": "16714-181-02", "marketing_start_date": "20070725"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16714-181-03)", "package_ndc": "16714-181-03", "marketing_start_date": "20070725"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16714-181-04)", "package_ndc": "16714-181-04", "marketing_start_date": "20070725"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-181-05)", "package_ndc": "16714-181-05", "marketing_start_date": "20070725"}], "brand_name": "Paroxetine", "product_id": "16714-181_0e3542cb-82a1-4a53-b814-55cfa4075ba6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "16714-181", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA078406", "marketing_category": "ANDA", "marketing_start_date": "20070725", "listing_expiration_date": "20261231"}