Duloxetine

Generic: Duloxetine

Labeler: Quality Care Products LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

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 60 mg/1

Identifiers & Regulatory

Product NDC 55700-628
Product ID 55700-628_e7698f58-da6d-4c61-bb09-374296df8f88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Marketing Start 2018-05-18
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55700628
Hyphenated Format 55700-628

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
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60)
source: ndc

Packages (2)

55700-628-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30) 55700-628-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60)

Ingredients (1)

DULOXETINE HYDROCHLORIDE (60 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": "e7698f58-da6d-4c61-bb09-374296df8f88", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["e4728363-a9ce-456b-ab5e-7e66b64f8787"], "manufacturer_name": ["Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30)", "package_ndc": "55700-628-30", "marketing_end_date": "20260228", "marketing_start_date": "20180518"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60)", "package_ndc": "55700-628-60", "marketing_end_date": "20260228", "marketing_start_date": "20180518"}], "brand_name": "Duloxetine", "product_id": "55700-628_e7698f58-da6d-4c61-bb09-374296df8f88", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "55700-628", "generic_name": "Duloxetine", "labeler_name": "Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20180518"}