duloxetine

Generic: duloxetine

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-170
Product ID 82009-170_8bd1cf58-1f36-4c7e-a549-24bb4ec3e154
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009170
Hyphenated Format 82009-170

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
UPC
0382009172309 0382009171104 0382009173108 0382009170107
UNII
9044SC542W

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 duloxetine (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-170-10)
source: ndc

Packages (1)

82009-170-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-170-10)

Ingredients (1)

duloxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Duloxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8bd1cf58-1f36-4c7e-a549-24bb4ec3e154", "openfda": {"upc": ["0382009172309", "0382009171104", "0382009173108", "0382009170107"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["b3b26383-9924-40f9-b4bb-43e30b70493e"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-170-10)", "package_ndc": "82009-170-10", "marketing_start_date": "20250701"}], "brand_name": "Duloxetine", "product_id": "82009-170_8bd1cf58-1f36-4c7e-a549-24bb4ec3e154", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "82009-170", "generic_name": "Duloxetine", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}