paroxetine

Generic: paroxetine

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

Drug Facts

Product Profile

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

paroxetine hydrochloride hemihydrate 20 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3518
Product ID 70518-3518_37ed270f-b8b2-01e6-e063-6294a90af214
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
Marketing Start 2022-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183518
Hyphenated Format 70518-3518

Supplemental Identifiers

RxCUI
1738495
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
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3518-1)
  • 100 POUCH in 1 BOX (70518-3518-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3518-3)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-4)
source: ndc

Packages (4)

70518-3518-0 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-0) 70518-3518-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3518-1) 70518-3518-2 100 POUCH in 1 BOX (70518-3518-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3518-3) 70518-3518-4 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-4)

Ingredients (1)

paroxetine hydrochloride hemihydrate (20 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": "37ed270f-b8b2-01e6-e063-6294a90af214", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738495"], "spl_set_id": ["05ec70fd-4c65-495f-ba12-e8433a10b655"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-0)", "package_ndc": "70518-3518-0", "marketing_start_date": "20220913"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3518-1)", "package_ndc": "70518-3518-1", "marketing_start_date": "20220929"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3518-2)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3518-3)", "package_ndc": "70518-3518-2", "marketing_start_date": "20250131"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3518-4)", "package_ndc": "70518-3518-4", "marketing_start_date": "20250618"}], "brand_name": "Paroxetine", "product_id": "70518-3518_37ed270f-b8b2-01e6-e063-6294a90af214", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-3518", "generic_name": "Paroxetine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20220913", "listing_expiration_date": "20261231"}