paroxetine

Generic: paroxetine

Labeler: nucare pharamceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler nucare pharamceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
NuCare Pharamceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-2535
Product ID 68071-2535_49dcbbe1-ceb2-c8eb-e063-6394a90a9c5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2027-12-31
Marketing Start 2007-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680712535
Hyphenated Format 68071-2535

Supplemental Identifiers

RxCUI
1738483
UPC
0368071253597
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 (source: ndc)
Application Number ANDA077584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-2535-9)
source: ndc

Packages (1)

68071-2535-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-2535-9)

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": "49dcbbe1-ceb2-c8eb-e063-6394a90a9c5e", "openfda": {"upc": ["0368071253597"], "unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["49dc055c-faef-0be3-e063-6394a90a934f"], "manufacturer_name": ["NuCare Pharamceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-2535-9)", "package_ndc": "68071-2535-9", "marketing_start_date": "20260202"}], "brand_name": "Paroxetine", "product_id": "68071-2535_49dcbbe1-ceb2-c8eb-e063-6394a90a9c5e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68071-2535", "generic_name": "Paroxetine", "labeler_name": "NuCare Pharamceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20271231"}