duloxetine

Generic: duloxetine

Labeler: inventia healthcare limited.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler inventia healthcare limited.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Inventia Healthcare Limited.

Identifiers & Regulatory

Product NDC 49252-009
Product ID 49252-009_3fb45d3e-3fbc-8814-e063-6294a90a4a70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202336
Listing Expiration 2026-12-31
Marketing Start 2015-12-05

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 49252009
Hyphenated Format 49252-009

Supplemental Identifiers

RxCUI
596926 596930 596934
UPC
0349252007574 0349252009103 0349252008106 0349252008571 0349252009578
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 ANDA202336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-10)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-11)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-12)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-18)
  • 100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-009-57)
source: ndc

Packages (5)

49252-009-10 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-10) 49252-009-11 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-11) 49252-009-12 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-12) 49252-009-18 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-18) 49252-009-57 100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-009-57)

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": "3fb45d3e-3fbc-8814-e063-6294a90a4a70", "openfda": {"upc": ["0349252007574", "0349252009103", "0349252008106", "0349252008571", "0349252009578"], "unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["eab90059-ea1c-46c1-884d-c15e7c562a01"], "manufacturer_name": ["Inventia Healthcare Limited."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-10)", "package_ndc": "49252-009-10", "marketing_start_date": "20151205"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-11)", "package_ndc": "49252-009-11", "marketing_start_date": "20151205"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-12)", "package_ndc": "49252-009-12", "marketing_start_date": "20151205"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49252-009-18)", "package_ndc": "49252-009-18", "marketing_start_date": "20151205"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-009-57)", "package_ndc": "49252-009-57", "marketing_start_date": "20151205"}], "brand_name": "duloxetine", "product_id": "49252-009_3fb45d3e-3fbc-8814-e063-6294a90a4a70", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "49252-009", "generic_name": "duloxetine", "labeler_name": "Inventia Healthcare Limited.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA202336", "marketing_category": "ANDA", "marketing_start_date": "20151205", "listing_expiration_date": "20261231"}