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 20 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7897
Product ID 68788-7897_8facbf87-c840-46ba-b14e-95b4e461a9e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2021-05-14

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 687887897
Hyphenated Format 68788-7897

Supplemental Identifiers

RxCUI
596926
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
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-3)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-6)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-9)
source: ndc

Packages (3)

68788-7897-3 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-3) 68788-7897-6 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-6) 68788-7897-9 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-9)

Ingredients (1)

duloxetine hydrochloride (20 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": "8facbf87-c840-46ba-b14e-95b4e461a9e7", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["29eacc40-cbec-4cc9-8556-773346617e85"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-3)", "package_ndc": "68788-7897-3", "marketing_start_date": "20210514"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-6)", "package_ndc": "68788-7897-6", "marketing_start_date": "20210514"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7897-9)", "package_ndc": "68788-7897-9", "marketing_start_date": "20210514"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "68788-7897_8facbf87-c840-46ba-b14e-95b4e461a9e7", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68788-7897", "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": "20 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20210514", "listing_expiration_date": "20261231"}