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 60 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6775
Product ID 50090-6775_81481944-52f6-4e1a-a841-c9a1a066e7d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090694
Listing Expiration 2027-12-31
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 500906775
Hyphenated Format 50090-6775

Supplemental Identifiers

RxCUI
596934
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 ANDA090694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-0)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-1)
source: ndc

Packages (2)

50090-6775-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-0) 50090-6775-1 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-1)

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": "81481944-52f6-4e1a-a841-c9a1a066e7d2", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["cdd870a9-3bed-42fc-b175-48aed5321969"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-0)", "package_ndc": "50090-6775-0", "marketing_start_date": "20231024"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6775-1)", "package_ndc": "50090-6775-1", "marketing_start_date": "20231024"}], "brand_name": "Duloxetine", "product_id": "50090-6775_81481944-52f6-4e1a-a841-c9a1a066e7d2", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "50090-6775", "generic_name": "Duloxetine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA090694", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20271231"}