paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1253
Product ID 70518-1253_48c31a65-991c-7da8-e063-6294a90aac40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2027-12-31
Marketing Start 2018-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181253
Hyphenated Format 70518-1253

Supplemental Identifiers

RxCUI
1738511
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
  • 40 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-1253-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2)
source: ndc

Packages (1)

70518-1253-1 30 POUCH in 1 BOX (70518-1253-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2)

Ingredients (1)

paroxetine hydrochloride hemihydrate (40 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": "48c31a65-991c-7da8-e063-6294a90aac40", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738511"], "spl_set_id": ["22174520-4b78-4841-96f7-530ba12d2cf1"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-1253-1)  / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2)", "package_ndc": "70518-1253-1", "marketing_start_date": "20220114"}], "brand_name": "Paroxetine", "product_id": "70518-1253_48c31a65-991c-7da8-e063-6294a90aac40", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-1253", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20180612", "listing_expiration_date": "20271231"}