paroxetine

Generic: paroxetine hydrochloride hemihydrate

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

Drug Facts

Product Profile

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

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3843
Product ID 68071-3843_3c413ebc-e0bd-64b5-e063-6294a90a45a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2022-03-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713843
Hyphenated Format 68071-3843

Supplemental Identifiers

RxCUI
1738483
UPC
0368071384314
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 (68071-3843-1)
source: ndc

Packages (1)

68071-3843-1 30 TABLET, FILM COATED in 1 BOTTLE (68071-3843-1)

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": "3c413ebc-e0bd-64b5-e063-6294a90a45a1", "openfda": {"upc": ["0368071384314"], "unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["34909bfb-b4ad-25c4-e063-6294a90a0296"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3843-1)", "package_ndc": "68071-3843-1", "marketing_start_date": "20250507"}], "brand_name": "Paroxetine", "product_id": "68071-3843_3c413ebc-e0bd-64b5-e063-6294a90a45a1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68071-3843", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20220329", "listing_expiration_date": "20261231"}