paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-527
Product ID 71205-527_64b95939-234b-41a2-aaad-c101884e223c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205527
Hyphenated Format 71205-527

Supplemental Identifiers

RxCUI
1738483
UPC
0371205527303
UNII
X2ELS050D8

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 (71205-527-30)
source: ndc

Packages (1)

71205-527-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-527-30)

Ingredients (1)

paroxetine hydrochloride (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": "64b95939-234b-41a2-aaad-c101884e223c", "openfda": {"upc": ["0371205527303"], "unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["ce168c41-a860-45f5-bae8-7b3d9b48d86a"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-527-30)", "package_ndc": "71205-527-30", "marketing_start_date": "20210127"}], "brand_name": "Paroxetine", "product_id": "71205-527_64b95939-234b-41a2-aaad-c101884e223c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71205-527", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}