duloxetine

Generic: duloxetine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler coupler llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1585
Product ID 67046-1585_47f98b3c-9a0b-755e-e063-6394a90ab490
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Listing Expiration 2027-12-31
Marketing Start 2025-09-15

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 670461585
Hyphenated Format 67046-1585

Supplemental Identifiers

RxCUI
596930
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 (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA090694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1585-3)
source: ndc

Packages (1)

67046-1585-3 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1585-3)

Ingredients (1)

duloxetine hydrochloride (30 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": "47f98b3c-9a0b-755e-e063-6394a90ab490", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["3edce3bd-1102-5951-e063-6394a90ae6c5"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1585-3)", "package_ndc": "67046-1585-3", "marketing_start_date": "20250915"}], "brand_name": "Duloxetine", "product_id": "67046-1585_47f98b3c-9a0b-755e-e063-6394a90ab490", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "67046-1585", "generic_name": "Duloxetine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA090694", "marketing_category": "ANDA", "marketing_start_date": "20250915", "listing_expiration_date": "20271231"}