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 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8782
Product ID 68788-8782_c45d0905-3478-4da4-b114-9f4cfb4a58ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Listing Expiration 2027-12-31
Marketing Start 2024-12-11

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 687888782
Hyphenated Format 68788-8782

Supplemental Identifiers

RxCUI
616402
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 ANDA090694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-6)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-9)
source: ndc

Packages (3)

68788-8782-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-3) 68788-8782-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-6) 68788-8782-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-9)

Ingredients (1)

duloxetine hydrochloride (40 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": "c45d0905-3478-4da4-b114-9f4cfb4a58ef", "openfda": {"unii": ["9044SC542W"], "rxcui": ["616402"], "spl_set_id": ["ae381859-be09-43e1-8b56-d0d8f4b49020"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-3)", "package_ndc": "68788-8782-3", "marketing_start_date": "20241211"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-6)", "package_ndc": "68788-8782-6", "marketing_start_date": "20241211"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-9)", "package_ndc": "68788-8782-9", "marketing_start_date": "20241211"}], "brand_name": "Duloxetine", "product_id": "68788-8782_c45d0905-3478-4da4-b114-9f4cfb4a58ef", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68788-8782", "generic_name": "Duloxetine", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA090694", "marketing_category": "ANDA", "marketing_start_date": "20241211", "listing_expiration_date": "20271231"}