duloxetine

Generic: duloxetine

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

Drug Facts

Product Profile

Brand Name duloxetine
Generic Name duloxetine
Labeler bryant ranch prepack
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

duloxetine hydrochloride 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1964
Product ID 71335-1964_b4aff1e4-f7f7-4929-92fd-6c27babc38f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206653
Listing Expiration 2026-12-31
Marketing Start 2016-01-20

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 713351964
Hyphenated Format 71335-1964

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 (source: ndc)
Generic Name duloxetine (source: ndc)
Application Number ANDA206653 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-1)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-2)
  • 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-3)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-4)
source: ndc

Packages (4)

71335-1964-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-1) 71335-1964-2 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-2) 71335-1964-3 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-3) 71335-1964-4 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-4)

Ingredients (1)

duloxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

DULOXETINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b4aff1e4-f7f7-4929-92fd-6c27babc38f5", "openfda": {"unii": ["9044SC542W"], "rxcui": ["596926"], "spl_set_id": ["9a8cb289-0332-4835-960f-32d273092d15"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-1)", "package_ndc": "71335-1964-1", "marketing_start_date": "20210210"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-2)", "package_ndc": "71335-1964-2", "marketing_start_date": "20210210"}, {"sample": false, "description": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-3)", "package_ndc": "71335-1964-3", "marketing_start_date": "20210210"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1964-4)", "package_ndc": "71335-1964-4", "marketing_start_date": "20210210"}], "brand_name": "DULOXETINE", "product_id": "71335-1964_b4aff1e4-f7f7-4929-92fd-6c27babc38f5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Norepinephrine Uptake Inhibitors [MoA]", "Serotonin Uptake Inhibitors [MoA]", "Serotonin and Norepinephrine Reuptake Inhibitor [EPC]"], "product_ndc": "71335-1964", "generic_name": "Duloxetine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DULOXETINE", "active_ingredients": [{"name": "DULOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA206653", "marketing_category": "ANDA", "marketing_start_date": "20160120", "listing_expiration_date": "20261231"}