duloxetine

Generic: duloxetine hydrochloride

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

Drug Facts

Product Profile

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

duloxetine hydrochloride 20 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-608
Product ID 25000-608_c8aa863f-eb1f-4b66-9ec6-2af2c7958248
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090723
Listing Expiration 2026-12-31
Marketing Start 2022-05-27

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 25000608
Hyphenated Format 25000-608

Supplemental Identifiers

RxCUI
596926 596930 596934
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 ANDA090723 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06)
source: ndc

Packages (1)

25000-608-06 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06)

Ingredients (1)

duloxetine hydrochloride (20 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": "c8aa863f-eb1f-4b66-9ec6-2af2c7958248", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934"], "spl_set_id": ["3686cde5-f76d-4d16-aa5d-caceb8408f8c"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06)", "package_ndc": "25000-608-06", "marketing_start_date": "20220527"}], "brand_name": "Duloxetine", "product_id": "25000-608_c8aa863f-eb1f-4b66-9ec6-2af2c7958248", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "25000-608", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA090723", "marketing_category": "ANDA", "marketing_start_date": "20220527", "listing_expiration_date": "20261231"}