duloxetine

Generic: duloxetine

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler bluepoint laboratories
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 30 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-595
Product ID 68001-595_3cc7677d-d409-c32e-e063-6294a90a94f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208706
Listing Expiration 2026-12-31
Marketing Start 2023-07-28

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 68001595
Hyphenated Format 68001-595

Supplemental Identifiers

RxCUI
596926 596930 596934 616402
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 (source: ndc)
Application Number ANDA208706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-04)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-05)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-08)
source: ndc

Packages (3)

68001-595-04 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-04) 68001-595-05 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-05) 68001-595-08 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-08)

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": "3cc7677d-d409-c32e-e063-6294a90a94f4", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926", "596930", "596934", "616402"], "spl_set_id": ["1409fc2b-7252-472f-b719-e56141b36da2"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-04)", "package_ndc": "68001-595-04", "marketing_start_date": "20240222"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-05)", "package_ndc": "68001-595-05", "marketing_start_date": "20231110"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-595-08)", "package_ndc": "68001-595-08", "marketing_start_date": "20230728"}], "brand_name": "Duloxetine", "product_id": "68001-595_3cc7677d-d409-c32e-e063-6294a90a94f4", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68001-595", "generic_name": "Duloxetine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA208706", "marketing_category": "ANDA", "marketing_start_date": "20230728", "listing_expiration_date": "20261231"}