duloxetine

Generic: duloxetine

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

duloxetine hydrochloride 20 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-727
Product ID 55700-727_bb8fec7f-1868-42d9-8cfb-a180fe1124e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Marketing Start 2019-02-22
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 55700727
Hyphenated Format 55700-727

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 (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 (55700-727-30)
source: ndc

Packages (1)

55700-727-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-727-30)

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": "bb8fec7f-1868-42d9-8cfb-a180fe1124e4", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["4d489d05-e767-498f-8827-c03ebfc512e0"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-727-30)", "package_ndc": "55700-727-30", "marketing_end_date": "20260531", "marketing_start_date": "20190222"}], "brand_name": "Duloxetine", "product_id": "55700-727_bb8fec7f-1868-42d9-8cfb-a180fe1124e4", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "55700-727", "generic_name": "Duloxetine", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20190222"}