duloxetine

Generic: duloxetine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler american health packaging
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-723
Product ID 60687-723_3140ed8f-e974-d45b-e063-6294a90a725d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Marketing Start 2023-04-25
Marketing End 2026-05-31

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 60687723
Hyphenated Format 60687-723

Supplemental Identifiers

RxCUI
596926 596930 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 (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA090778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-723-21) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-723-11)
source: ndc

Packages (1)

60687-723-21 30 BLISTER PACK in 1 CARTON (60687-723-21) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-723-11)

Ingredients (1)

duloxetine hydrochloride (20 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": "3140ed8f-e974-d45b-e063-6294a90a725d", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["7da3d2c4-8793-4da3-b54a-ae20717cf066"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-723-21)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-723-11)", "package_ndc": "60687-723-21", "marketing_end_date": "20260531", "marketing_start_date": "20230425"}], "brand_name": "Duloxetine", "product_id": "60687-723_3140ed8f-e974-d45b-e063-6294a90a725d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "60687-723", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20230425"}