duloxetine

Generic: duloxetine

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

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler actavis pharma, inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-2892
Product ID 0228-2892_15b6b091-1064-440e-8ab4-6b4eb28adcf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090776
Listing Expiration 2026-12-31
Marketing Start 2013-12-17

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 02282892
Hyphenated Format 0228-2892

Supplemental Identifiers

RxCUI
596926 596930 596934
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 (source: ndc)
Application Number ANDA090776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-03)
  • 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96)
source: ndc

Packages (2)

0228-2892-03 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-03) 0228-2892-96 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96)

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": "15b6b091-1064-440e-8ab4-6b4eb28adcf4", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["9dab9154-b86f-40dc-a4d1-18e6534dbc78"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-03)", "package_ndc": "0228-2892-03", "marketing_start_date": "20131217"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0228-2892-96)", "package_ndc": "0228-2892-96", "marketing_start_date": "20140905"}], "brand_name": "Duloxetine", "product_id": "0228-2892_15b6b091-1064-440e-8ab4-6b4eb28adcf4", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "0228-2892", "generic_name": "Duloxetine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090776", "marketing_category": "ANDA", "marketing_start_date": "20131217", "listing_expiration_date": "20261231"}