duloxetine hydrochloride

Generic: duloxetine hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

duloxetine hydrochloride 30 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-161
Product ID 33342-161_d2bdee38-c510-432f-bf05-a8a573cf459c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204815
Listing Expiration 2026-12-31
Marketing Start 2017-03-24

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 33342161
Hyphenated Format 33342-161

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 hydrochloride (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA204815 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-07)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10)
  • 10 BLISTER PACK in 1 CARTON (33342-161-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-44)
source: ndc

Packages (4)

33342-161-07 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-07) 33342-161-10 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10) 33342-161-12 10 BLISTER PACK in 1 CARTON (33342-161-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 33342-161-44 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-44)

Ingredients (1)

duloxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Duloxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d2bdee38-c510-432f-bf05-a8a573cf459c", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["177ce798-3924-416b-ba37-23dfa911a43b"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-07)", "package_ndc": "33342-161-07", "marketing_start_date": "20170324"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10)", "package_ndc": "33342-161-10", "marketing_start_date": "20170324"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-161-12)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-161-12", "marketing_start_date": "20170324"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-44)", "package_ndc": "33342-161-44", "marketing_start_date": "20170324"}], "brand_name": "Duloxetine Hydrochloride", "product_id": "33342-161_d2bdee38-c510-432f-bf05-a8a573cf459c", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "33342-161", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine Hydrochloride", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA204815", "marketing_category": "ANDA", "marketing_start_date": "20170324", "listing_expiration_date": "20261231"}