duloxetine

Generic: duloxetine

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler st. mary's medical park pharmacy
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-461
Product ID 60760-461_45745bf3-a131-b51a-e063-6394a90a712e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2019-09-05

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 60760461
Hyphenated Format 60760-461

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 ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-60)
source: ndc

Packages (2)

60760-461-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-30) 60760-461-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-60)

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": "45745bf3-a131-b51a-e063-6394a90a712e", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["9221aea1-8de1-b94e-e053-2a95a90a1eae"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-30)", "package_ndc": "60760-461-30", "marketing_start_date": "20190905"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-461-60)", "package_ndc": "60760-461-60", "marketing_start_date": "20191021"}], "brand_name": "Duloxetine", "product_id": "60760-461_45745bf3-a131-b51a-e063-6394a90a712e", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "60760-461", "generic_name": "Duloxetine", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20190905", "listing_expiration_date": "20261231"}