duloxetine

Generic: duloxetine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler cardinal health 107, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-2342
Product ID 55154-2342_4ab3f62d-40ab-4222-bf61-23c90df44aa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Marketing Start 2013-12-11
Marketing End 2026-04-30

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 551542342
Hyphenated Format 55154-2342

Supplemental Identifiers

RxCUI
596930 596934
UPC
0055154234108 0055154234207
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
  • 30 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-2342-0) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

55154-2342-0 10 BLISTER PACK in 1 BAG (55154-2342-0) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

duloxetine hydrochloride (30 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": "4ab3f62d-40ab-4222-bf61-23c90df44aa6", "openfda": {"upc": ["0055154234108", "0055154234207"], "unii": ["9044SC542W"], "rxcui": ["596930", "596934"], "spl_set_id": ["26e7c5d9-f191-43d5-81c8-e6cf1fcb3986"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-2342-0)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "55154-2342-0", "marketing_end_date": "20260430", "marketing_start_date": "20131211"}], "brand_name": "Duloxetine", "product_id": "55154-2342_4ab3f62d-40ab-4222-bf61-23c90df44aa6", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "55154-2342", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_end_date": "20260430", "marketing_start_date": "20131211"}