duloxetine

Generic: duloxetine

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

Drug Facts

Product Profile

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

duloxetine hydrochloride 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-403
Product ID 71610-403_43cd971a-bb4a-b6ca-e063-6394a90af045
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2017-03-16

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 71610403
Hyphenated Format 71610-403

Supplemental Identifiers

RxCUI
596934
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 (source: ndc)
Application Number ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-53)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-60)
source: ndc

Packages (2)

71610-403-53 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-53) 71610-403-60 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-60)

Ingredients (1)

duloxetine hydrochloride (60 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": "43cd971a-bb4a-b6ca-e063-6394a90af045", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["c482d64a-73dd-4af2-9b3c-efff47e7395c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-53)", "package_ndc": "71610-403-53", "marketing_start_date": "20251114"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-403-60)", "package_ndc": "71610-403-60", "marketing_start_date": "20200309"}], "brand_name": "Duloxetine", "product_id": "71610-403_43cd971a-bb4a-b6ca-e063-6394a90af045", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71610-403", "generic_name": "Duloxetine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20170316", "listing_expiration_date": "20261231"}