duloxetine d/r

Generic: duloxetine d/r

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine d/r
Generic Name duloxetine d/r
Labeler direct_rx
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-608
Product ID 72189-608_2ef97557-bb95-c5c8-e063-6294a90a56eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Listing Expiration 2026-12-31
Marketing Start 2025-01-16

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 72189608
Hyphenated Format 72189-608

Supplemental Identifiers

RxCUI
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 d/r (source: ndc)
Generic Name duloxetine d/r (source: ndc)
Application Number ANDA090694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-90)
source: ndc

Packages (3)

72189-608-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-30) 72189-608-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-60) 72189-608-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-90)

Ingredients (1)

duloxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Duloxetine D/R ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ef97557-bb95-c5c8-e063-6294a90a56eb", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["2bd76155-709b-86ad-e063-6294a90aa1c5"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-30)", "package_ndc": "72189-608-30", "marketing_start_date": "20250116"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-60)", "package_ndc": "72189-608-60", "marketing_start_date": "20250116"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-608-90)", "package_ndc": "72189-608-90", "marketing_start_date": "20250116"}], "brand_name": "Duloxetine D/R", "product_id": "72189-608_2ef97557-bb95-c5c8-e063-6294a90a56eb", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "72189-608", "generic_name": "Duloxetine D/R", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine D/R", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090694", "marketing_category": "ANDA", "marketing_start_date": "20250116", "listing_expiration_date": "20261231"}