duloxetine

Generic: duloxetine

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler preferred pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7672
Product ID 68788-7672_707ee23e-19a5-4e39-be4d-e262442a34a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2020-02-28

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 687887672
Hyphenated Format 68788-7672

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-0)
  • 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-1)
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-2)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-6)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-8)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-9)
source: ndc

Packages (7)

68788-7672-0 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-0) 68788-7672-1 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-1) 68788-7672-2 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-2) 68788-7672-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-3) 68788-7672-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-6) 68788-7672-8 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-8) 68788-7672-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-9)

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": "707ee23e-19a5-4e39-be4d-e262442a34a6", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["7a7c67be-6800-4ec3-9072-1e0e390a854b"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-0)", "package_ndc": "68788-7672-0", "marketing_start_date": "20200228"}, {"sample": false, "description": "10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-1)", "package_ndc": "68788-7672-1", "marketing_start_date": "20200228"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-2)", "package_ndc": "68788-7672-2", "marketing_start_date": "20200228"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-3)", "package_ndc": "68788-7672-3", "marketing_start_date": "20200228"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-6)", "package_ndc": "68788-7672-6", "marketing_start_date": "20200228"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-8)", "package_ndc": "68788-7672-8", "marketing_start_date": "20200228"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7672-9)", "package_ndc": "68788-7672-9", "marketing_start_date": "20200228"}], "brand_name": "Duloxetine", "product_id": "68788-7672_707ee23e-19a5-4e39-be4d-e262442a34a6", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68788-7672", "generic_name": "Duloxetine", "labeler_name": "Preferred Pharmaceuticals, Inc.", "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_start_date": "20200228", "listing_expiration_date": "20261231"}