duloxetine

Generic: duloxetine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler a-s medication solutions
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7812
Product ID 50090-7812_22329868-1b97-471b-b501-453b9896cc28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2017-03-16

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 500907812
Hyphenated Format 50090-7812

Supplemental Identifiers

RxCUI
596926
UNII
9044SC542W

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 ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-0)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-1)
source: ndc

Packages (2)

50090-7812-0 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-0) 50090-7812-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-1)

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": "22329868-1b97-471b-b501-453b9896cc28", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["7685a825-3c06-433d-ba98-4019c6ed2583"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-0)", "package_ndc": "50090-7812-0", "marketing_start_date": "20251208"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-7812-1)", "package_ndc": "50090-7812-1", "marketing_start_date": "20251208"}], "brand_name": "Duloxetine", "product_id": "50090-7812_22329868-1b97-471b-b501-453b9896cc28", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "50090-7812", "generic_name": "Duloxetine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20170316", "listing_expiration_date": "20261231"}