duloxetine

Generic: duloxetine hydrochloride

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

Drug Facts

Product Profile

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

duloxetine hydrochloride 40 mg/1

Manufacturer
Quallent Pharmaceuticals Health, LLC

Identifiers & Regulatory

Product NDC 82009-031
Product ID 82009-031_c7833be1-34d9-43e4-8aff-966c14aa2798
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2018-05-21

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 82009031
Hyphenated Format 82009-031

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
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 hydrochloride (source: ndc)
Application Number ANDA203088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-031-90)
source: ndc

Packages (1)

82009-031-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-031-90)

Ingredients (1)

duloxetine hydrochloride (40 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": "c7833be1-34d9-43e4-8aff-966c14aa2798", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["31362045-201f-45f3-99f2-a5e322a0c30b"], "manufacturer_name": ["Quallent Pharmaceuticals Health, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-031-90)", "package_ndc": "82009-031-90", "marketing_start_date": "20230601"}], "brand_name": "Duloxetine", "product_id": "82009-031_c7833be1-34d9-43e4-8aff-966c14aa2798", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "82009-031", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Quallent Pharmaceuticals Health, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20180521", "listing_expiration_date": "20261231"}