FDA.reportPublic FDA data

NDC 71335-1964-03 - DULOXETINE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-1964
Requested NDC
71335-1964-03
Package NDCs from labels
71335-1964-1, 71335-1964-2, 71335-1964-3, 71335-1964-4, 71335-1964-03
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DULOXETINE - Bryant Ranch PrepackBryant Ranch Prepack2024-04-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1964-1DULOXETINE30 in 1 BOTTLECAPSULE, DELAYED RELEASE30102
71335-1964-2DULOXETINE60 in 1 BOTTLECAPSULE, DELAYED RELEASE60102
71335-1964-3DULOXETINE28 in 1 BOTTLECAPSULE, DELAYED RELEASE28102
71335-1964-4DULOXETINE90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1964DULOXETINE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240504_9a8cb289-0332-4835-960f-32d273092d15.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 117 · 2,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
DuloxetineDULOXETINEHAWAII REPACK, INCb32a39d8-5f1a-4e44-bc46-b65925bde7532026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
DuloxetineDULOXETINEHAWAII REPACK, INC.79bfd6be-a1ff-4786-b4e2-abbd0a3e39322026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
rxcui: 596930
rxcui: 596934
unii: 9044SC542W
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
DuloxetineDULOXETINEREMEDYREPACK INC.ed164dbb-e713-42d1-a78e-31145578b9f82026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596930
unii: 9044SC542W
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.