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 30 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-9301
Product ID 68788-9301_7ad6ae66-a039-4738-beab-67dbfd83568d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2015-03-23

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 687889301
Hyphenated Format 68788-9301

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

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-0)
  • 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-1)
  • 20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-2)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-3)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-6)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-9)
source: ndc

Packages (6)

68788-9301-0 6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-0) 68788-9301-1 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-1) 68788-9301-2 20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-2) 68788-9301-3 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-3) 68788-9301-6 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-6) 68788-9301-9 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-9)

Ingredients (1)

duloxetine hydrochloride (30 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": "7ad6ae66-a039-4738-beab-67dbfd83568d", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["49821f58-a5a6-47c5-96d1-f673ef2f4bd5"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-0)", "package_ndc": "68788-9301-0", "marketing_start_date": "20150323"}, {"sample": false, "description": "10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-1)", "package_ndc": "68788-9301-1", "marketing_start_date": "20150323"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-2)", "package_ndc": "68788-9301-2", "marketing_start_date": "20150323"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-3)", "package_ndc": "68788-9301-3", "marketing_start_date": "20150323"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-6)", "package_ndc": "68788-9301-6", "marketing_start_date": "20150323"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9301-9)", "package_ndc": "68788-9301-9", "marketing_start_date": "20150323"}], "brand_name": "DULOXETINE DELAYED-RELEASE", "product_id": "68788-9301_7ad6ae66-a039-4738-beab-67dbfd83568d", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "68788-9301", "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": "30 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20150323", "listing_expiration_date": "20261231"}