duloxetine

Generic: duloxetine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-383
Product ID 47335-383_cec0154d-5c8c-496d-89bd-ba2a93aee774
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090745
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 47335383
Hyphenated Format 47335-383

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0347335383836 0347335382839
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 ANDA090745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18)
  • 100 BLISTER PACK in 1 CARTON (47335-383-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88)
source: ndc

Packages (5)

47335-383-08 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08) 47335-383-18 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18) 47335-383-61 100 BLISTER PACK in 1 CARTON (47335-383-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 47335-383-83 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83) 47335-383-88 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88)

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": "cec0154d-5c8c-496d-89bd-ba2a93aee774", "openfda": {"upc": ["0347335383836", "0347335382839"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["f16beb64-5878-486a-82ee-8e83e728f26c"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08)", "package_ndc": "47335-383-08", "marketing_start_date": "20131211"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18)", "package_ndc": "47335-383-18", "marketing_start_date": "20131211"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (47335-383-61)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "47335-383-61", "marketing_start_date": "20131211"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83)", "package_ndc": "47335-383-83", "marketing_start_date": "20131211"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88)", "package_ndc": "47335-383-88", "marketing_start_date": "20131211"}], "brand_name": "Duloxetine", "product_id": "47335-383_cec0154d-5c8c-496d-89bd-ba2a93aee774", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "47335-383", "generic_name": "Duloxetine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090745", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20261231"}