duloxetine delayed-release

Generic: duloxetine hydrochloride

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

Drug Facts

Product Profile

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

duloxetine hydrochloride 40 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-024
Product ID 82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2018-05-21

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 82804024
Hyphenated Format 82804-024

Supplemental Identifiers

RxCUI
616402
UPC
0382804024308
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 delayed-release (source: ndc)
Generic Name duloxetine hydrochloride (source: ndc)
Application Number ANDA203088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90)
source: ndc

Packages (3)

82804-024-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30) 82804-024-60 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60) 82804-024-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90)

Ingredients (1)

duloxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

Duloxetine Delayed-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f5e7503a-b28f-4cd0-a4ee-47bdca88d54b", "openfda": {"upc": ["0382804024308"], "unii": ["9044SC542W"], "rxcui": ["616402"], "spl_set_id": ["f5e7503a-b28f-4cd0-a4ee-47bdca88d54b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30)", "package_ndc": "82804-024-30", "marketing_start_date": "20231016"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60)", "package_ndc": "82804-024-60", "marketing_start_date": "20231016"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90)", "package_ndc": "82804-024-90", "marketing_start_date": "20231016"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54b", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "82804-024", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20180521", "listing_expiration_date": "20261231"}