duloxetine

Generic: duloxetine

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 40 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-297
Product ID 68180-297_7efa28f3-0b15-4e1c-835f-2f1dff37bee8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Listing Expiration 2026-12-31
Marketing Start 2015-05-25

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 68180297
Hyphenated Format 68180-297

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
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 ANDA090694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-06)
source: ndc

Packages (1)

68180-297-06 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-06)

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": "7efa28f3-0b15-4e1c-835f-2f1dff37bee8", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["829a4f51-c882-4b64-81f3-abfb03a52ebe"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-06)", "package_ndc": "68180-297-06", "marketing_start_date": "20150715"}], "brand_name": "Duloxetine", "product_id": "68180-297_7efa28f3-0b15-4e1c-835f-2f1dff37bee8", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68180-297", "generic_name": "Duloxetine", "labeler_name": "Lupin 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": "20150525", "listing_expiration_date": "20261231"}