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 30 mg/1

Identifiers & Regulatory

Product NDC 83008-046
Product ID 83008-046_b207672b-4423-4e03-8223-51d62aa7920f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Marketing Start 2024-02-15
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008046
Hyphenated Format 83008-046

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 BOTTLE (83008-046-30)
source: ndc

Packages (1)

83008-046-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83008-046-30)

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": "b207672b-4423-4e03-8223-51d62aa7920f", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["2163f0f2-95f1-4e2c-9ad3-eaab00f6dbf9"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83008-046-30)", "package_ndc": "83008-046-30", "marketing_end_date": "20260228", "marketing_start_date": "20240215"}], "brand_name": "Duloxetine", "product_id": "83008-046_b207672b-4423-4e03-8223-51d62aa7920f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "83008-046", "generic_name": "Duloxetine", "labeler_name": "Quality Care Products, 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_end_date": "20260228", "marketing_start_date": "20240215"}