duloxetine

Generic: duloxetine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7043
Product ID 0904-7043_d893474d-4a41-4771-88d3-25ea749deeff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Marketing Start 2013-12-11
Marketing End 2026-03-31

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 09047043
Hyphenated Format 0904-7043

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 (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
  • 30 BLISTER PACK in 1 CARTON (0904-7043-04) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7043-04 30 BLISTER PACK in 1 CARTON (0904-7043-04) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

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": "d893474d-4a41-4771-88d3-25ea749deeff", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["fdc774b5-c8f2-4daf-94cb-7e73548b541a"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7043-04)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7043-04", "marketing_end_date": "20260331", "marketing_start_date": "20131211"}], "brand_name": "Duloxetine", "product_id": "0904-7043_d893474d-4a41-4771-88d3-25ea749deeff", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "0904-7043", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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_end_date": "20260331", "marketing_start_date": "20131211"}