duloxetine

Generic: duloxetine

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler zydus lifesciences limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-801
Product ID 65841-801_22968719-7127-4aab-b4c4-4497de16ca23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090739
Listing Expiration 2026-12-31
Marketing Start 2014-05-27

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 65841801
Hyphenated Format 65841-801

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0365841800166 0365841801163 0365841799163
UNII
9044SC542W

Packaging Origin

Original Packager
true

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 ANDA090739 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16)
source: ndc

Packages (3)

65841-801-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06) 65841-801-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-10) 65841-801-16 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16)

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": "22968719-7127-4aab-b4c4-4497de16ca23", "openfda": {"upc": ["0365841800166", "0365841801163", "0365841799163"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["f36b414e-ace4-4f04-a80f-75bb25db430d"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-06)", "package_ndc": "65841-801-06", "marketing_start_date": "20140527"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-10)", "package_ndc": "65841-801-10", "marketing_start_date": "20140527"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-801-16)", "package_ndc": "65841-801-16", "marketing_start_date": "20140527"}], "brand_name": "Duloxetine", "product_id": "65841-801_22968719-7127-4aab-b4c4-4497de16ca23", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "65841-801", "generic_name": "Duloxetine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090739", "marketing_category": "ANDA", "marketing_start_date": "20140527", "listing_expiration_date": "20261231"}