duloxetine

Generic: duloxetine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-017
Product ID 57237-017_96d64764-43ee-44ed-9bf0-600ec4f88981
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 57237017
Hyphenated Format 57237-017

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0357237018309 0357237017609 0357237019306
UNII
9044SC542W

Packaging Origin

Original Packager
true

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
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-017-60)
source: ndc

Packages (1)

57237-017-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-017-60)

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": "96d64764-43ee-44ed-9bf0-600ec4f88981", "openfda": {"upc": ["0357237018309", "0357237017609", "0357237019306"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["ea2dc1a6-22d5-4295-9d39-9bf015dc5a89"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57237-017-60)", "package_ndc": "57237-017-60", "marketing_end_date": "20260430", "marketing_start_date": "20131211"}], "brand_name": "Duloxetine", "product_id": "57237-017_96d64764-43ee-44ed-9bf0-600ec4f88981", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "57237-017", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "20260430", "marketing_start_date": "20131211"}