duloxetine

Generic: duloxetine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine hydrochloride
Labeler proficient rx lp
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-612
Product ID 63187-612_9e0aea8e-e493-432d-a390-5f6d7944ba69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090778
Listing Expiration 2026-12-31
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 63187612
Hyphenated Format 63187-612

Supplemental Identifiers

RxCUI
596930
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 hydrochloride (source: ndc)
Application Number ANDA090778 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-90)
source: ndc

Packages (3)

63187-612-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-30) 63187-612-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-60) 63187-612-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-90)

Ingredients (1)

duloxetine hydrochloride (30 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": "9e0aea8e-e493-432d-a390-5f6d7944ba69", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["c34f6115-f447-450f-8c83-58f3c51a76c9"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-30)", "package_ndc": "63187-612-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-60)", "package_ndc": "63187-612-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-612-90)", "package_ndc": "63187-612-90", "marketing_start_date": "20181201"}], "brand_name": "Duloxetine", "product_id": "63187-612_9e0aea8e-e493-432d-a390-5f6d7944ba69", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "63187-612", "generic_name": "Duloxetine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA090778", "marketing_category": "ANDA", "marketing_start_date": "20131211", "listing_expiration_date": "20261231"}