duloxetine delayed-release

Generic: duloxetine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name duloxetine delayed-release
Generic Name duloxetine hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE, DELAYED RELEASE PELLETS
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 60 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0509
Product ID 71335-0509_f56840bd-a85a-489d-ae5a-cf6fe696f1a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203088
Listing Expiration 2026-12-31
Marketing Start 2014-06-11

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 713350509
Hyphenated Format 71335-0509

Supplemental Identifiers

RxCUI
596934
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
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-1)
  • 28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-2)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-3)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-4)
  • 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-5)
  • 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-6)
source: ndc

Packages (6)

71335-0509-1 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-1) 71335-0509-2 28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-2) 71335-0509-3 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-3) 71335-0509-4 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-4) 71335-0509-5 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-5) 71335-0509-6 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-6)

Ingredients (1)

duloxetine hydrochloride (60 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": "f56840bd-a85a-489d-ae5a-cf6fe696f1a8", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596934"], "spl_set_id": ["0c82422a-d493-4dda-8626-0d9baa25db8c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-1)", "package_ndc": "71335-0509-1", "marketing_start_date": "20210224"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-2)", "package_ndc": "71335-0509-2", "marketing_start_date": "20240529"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-3)", "package_ndc": "71335-0509-3", "marketing_start_date": "20210224"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-4)", "package_ndc": "71335-0509-4", "marketing_start_date": "20210407"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-5)", "package_ndc": "71335-0509-5", "marketing_start_date": "20220831"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-6)", "package_ndc": "71335-0509-6", "marketing_start_date": "20240529"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "71335-0509_f56840bd-a85a-489d-ae5a-cf6fe696f1a8", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71335-0509", "generic_name": "DULOXETINE HYDROCHLORIDE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duloxetine", "brand_name_suffix": "Delayed-Release", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}