duloxetine delayed-release

Generic: duloxetine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine delayed-release
Generic Name duloxetine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8362
Product ID 68788-8362_19b034a2-26d7-4c9b-b8a6-391e06a31adb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 687888362
Hyphenated Format 68788-8362

Supplemental Identifiers

RxCUI
616402
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
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-0)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-3)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-9)
source: ndc

Packages (3)

68788-8362-0 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-0) 68788-8362-3 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-3) 68788-8362-9 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-9)

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": "19b034a2-26d7-4c9b-b8a6-391e06a31adb", "openfda": {"unii": ["9044SC542W"], "rxcui": ["616402"], "spl_set_id": ["2c233b3f-83de-40c4-9f1d-81f901f89459"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-0)", "package_ndc": "68788-8362-0", "marketing_start_date": "20230314"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-3)", "package_ndc": "68788-8362-3", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-8362-9)", "package_ndc": "68788-8362-9", "marketing_start_date": "20230201"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "68788-8362_19b034a2-26d7-4c9b-b8a6-391e06a31adb", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68788-8362", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20230201", "listing_expiration_date": "20261231"}