duloxetine delayed-release

Generic: duloxetine hydrochloride

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

Drug Facts

Product Profile

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

duloxetine hydrochloride 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-025
Product ID 43353-025_159efe2d-21ab-358f-e063-6394a90a8ded
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2014-06-11

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 43353025
Hyphenated Format 43353-025

Supplemental Identifiers

RxCUI
596926 596930 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 delayed-release (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA203088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60)
source: ndc

Packages (2)

43353-025-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30) 43353-025-60 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60)

Ingredients (1)

duloxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Duloxetine Delayed-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "159efe2d-21ab-358f-e063-6394a90a8ded", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["c94339ab-3aaf-4cc9-b770-650b433bcce8"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30)", "package_ndc": "43353-025-30", "marketing_start_date": "20150425"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60)", "package_ndc": "43353-025-60", "marketing_start_date": "20150425"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "43353-025_159efe2d-21ab-358f-e063-6394a90a8ded", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "43353-025", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}