duloxetine

Generic: duloxetine hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-282
Product ID 59651-282_ad4ac841-ec88-467d-9970-ccdbba56bd11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Listing Expiration 2026-12-31
Marketing Start 2013-12-11

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 59651282
Hyphenated Format 59651-282

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0359651279601 0359651280300 0359651282304
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 hydrochloride (source: ndc)
Application Number ANDA090778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-30)
  • 10 BLISTER PACK in 1 CARTON (59651-282-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-90)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-99)
source: ndc

Packages (4)

59651-282-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-30) 59651-282-78 10 BLISTER PACK in 1 CARTON (59651-282-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10) 59651-282-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-90) 59651-282-99 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-99)

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": "ad4ac841-ec88-467d-9970-ccdbba56bd11", "openfda": {"upc": ["0359651279601", "0359651280300", "0359651282304"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["3adfceb3-5f89-4bcf-b874-e3cb572a98b6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-30)", "package_ndc": "59651-282-30", "marketing_start_date": "20131211"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (59651-282-78)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10)", "package_ndc": "59651-282-78", "marketing_start_date": "20131211"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-90)", "package_ndc": "59651-282-90", "marketing_start_date": "20131211"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-282-99)", "package_ndc": "59651-282-99", "marketing_start_date": "20131211"}], "brand_name": "Duloxetine", "product_id": "59651-282_ad4ac841-ec88-467d-9970-ccdbba56bd11", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "59651-282", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20261231"}