duloxetine dr

Generic: duloxetine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine dr
Generic Name duloxetine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0311
Product ID 80425-0311_2a9bfe6a-6d6d-b262-e063-6294a90a1cf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2023-04-07

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 804250311
Hyphenated Format 80425-0311

Supplemental Identifiers

RxCUI
596926
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 dr (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-1)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-2)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-3)
source: ndc

Packages (3)

80425-0311-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-1) 80425-0311-2 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-2) 80425-0311-3 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-3)

Ingredients (1)

duloxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Duloxetine DR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a9bfe6a-6d6d-b262-e063-6294a90a1cf3", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["f8c0bc80-b34e-daa8-e053-6394a90a05c2"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-1)", "package_ndc": "80425-0311-1", "marketing_start_date": "20230407"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-2)", "package_ndc": "80425-0311-2", "marketing_start_date": "20230407"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0311-3)", "package_ndc": "80425-0311-3", "marketing_start_date": "20230407"}], "brand_name": "Duloxetine DR", "product_id": "80425-0311_2a9bfe6a-6d6d-b262-e063-6294a90a1cf3", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "80425-0311", "generic_name": "Duloxetine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "DR", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20230407", "listing_expiration_date": "20261231"}