duloxetine

Generic: duloxetine

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler solco healthcare us, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-379
Product ID 43547-379_1b037cb5-9db9-44a6-89dd-1cf1dcf895fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206653
Listing Expiration 2026-12-31
Marketing Start 2016-01-20

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 43547379
Hyphenated Format 43547-379

Supplemental Identifiers

RxCUI
596926 596930 596934
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 ANDA206653 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-03)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-06)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-09)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-11)
source: ndc

Packages (4)

43547-379-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-03) 43547-379-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-06) 43547-379-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-09) 43547-379-11 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-11)

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": "1b037cb5-9db9-44a6-89dd-1cf1dcf895fb", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["a105a648-6a97-4151-b9de-d7eac90a8f79"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-03)", "package_ndc": "43547-379-03", "marketing_start_date": "20160120"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-06)", "package_ndc": "43547-379-06", "marketing_start_date": "20160120"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-09)", "package_ndc": "43547-379-09", "marketing_start_date": "20160120"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-11)", "package_ndc": "43547-379-11", "marketing_start_date": "20160120"}], "brand_name": "DULOXETINE", "product_id": "43547-379_1b037cb5-9db9-44a6-89dd-1cf1dcf895fb", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "43547-379", "generic_name": "Duloxetine", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DULOXETINE", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA206653", "marketing_category": "ANDA", "marketing_start_date": "20160120", "listing_expiration_date": "20261231"}