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 30 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0392
Product ID 71335-0392_e8fe3c0e-a41b-4e12-a4c7-71c8f6e37de5
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 713350392
Hyphenated Format 71335-0392

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
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-1)
  • 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-2)
  • 28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-3)
  • 6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-4)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-5)
  • 15 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-6)
  • 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-7)
  • 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-8)
source: ndc

Packages (8)

71335-0392-1 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-1) 71335-0392-2 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-2) 71335-0392-3 28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-3) 71335-0392-4 6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-4) 71335-0392-5 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-5) 71335-0392-6 15 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-6) 71335-0392-7 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-7) 71335-0392-8 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-8)

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": "e8fe3c0e-a41b-4e12-a4c7-71c8f6e37de5", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596930"], "spl_set_id": ["41876761-9d5b-4190-a200-6a822c54582e"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-1)", "package_ndc": "71335-0392-1", "marketing_start_date": "20180312"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-2)", "package_ndc": "71335-0392-2", "marketing_start_date": "20180322"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-3)", "package_ndc": "71335-0392-3", "marketing_start_date": "20240529"}, {"sample": false, "description": "6 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-4)", "package_ndc": "71335-0392-4", "marketing_start_date": "20181108"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-5)", "package_ndc": "71335-0392-5", "marketing_start_date": "20180327"}, {"sample": false, "description": "15 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-6)", "package_ndc": "71335-0392-6", "marketing_start_date": "20190218"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-7)", "package_ndc": "71335-0392-7", "marketing_start_date": "20190723"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-8)", "package_ndc": "71335-0392-8", "marketing_start_date": "20240529"}], "brand_name": "Duloxetine Delayed-Release", "product_id": "71335-0392_e8fe3c0e-a41b-4e12-a4c7-71c8f6e37de5", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71335-0392", "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": "30 mg/1"}], "application_number": "ANDA203088", "marketing_category": "ANDA", "marketing_start_date": "20140611", "listing_expiration_date": "20261231"}