duloxetine

Generic: duloxetine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-401
Product ID 71610-401_157fe8e5-a477-47eb-adac-6b9ffe571af9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Listing Expiration 2026-12-31
Marketing Start 2013-12-11

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 71610401
Hyphenated Format 71610-401

Supplemental Identifiers

RxCUI
596926 596930
UNII
9044SC542W

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 ANDA090778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3600 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-401-83)
source: ndc

Packages (1)

71610-401-83 3600 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-401-83)

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": "157fe8e5-a477-47eb-adac-6b9ffe571af9", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930"], "spl_set_id": ["b102b8e6-d58f-419c-bb35-720bafa13294"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "3600 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-401-83)", "package_ndc": "71610-401-83", "marketing_start_date": "20200226"}], "brand_name": "Duloxetine", "product_id": "71610-401_157fe8e5-a477-47eb-adac-6b9ffe571af9", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71610-401", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20261231"}