paroxetine

Generic: paroxetine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 10 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-319
Product ID 70954-319_367bb2bf-beef-4f9a-b045-0c23e9021701
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215003
Listing Expiration 2026-12-31
Marketing Start 2021-09-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954319
Hyphenated Format 70954-319

Supplemental Identifiers

RxCUI
312242
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 (source: ndc)
Application Number ANDA215003 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE (70954-319-10)
source: ndc

Packages (1)

70954-319-10 250 mL in 1 BOTTLE (70954-319-10)

Ingredients (1)

paroxetine hydrochloride hemihydrate (10 mg/5mL)

Linked Drug Pages (1)

Paroxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "367bb2bf-beef-4f9a-b045-0c23e9021701", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["312242"], "spl_set_id": ["134e76f0-45cf-47eb-b6e1-cdb3bb522a0a"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (70954-319-10)", "package_ndc": "70954-319-10", "marketing_start_date": "20210903"}], "brand_name": "Paroxetine", "product_id": "70954-319_367bb2bf-beef-4f9a-b045-0c23e9021701", "dosage_form": "SUSPENSION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70954-319", "generic_name": "Paroxetine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/5mL"}], "application_number": "ANDA215003", "marketing_category": "ANDA", "marketing_start_date": "20210903", "listing_expiration_date": "20261231"}