FDA.reportPublic FDA data

NDC 62034-021-11 - DULOXETINE DELAYED-RELEASE

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
62034-021
Requested NDC
62034-021-11
Package NDCs from labels
62034-021-11, 62034-021-77
Manufacturer
Blenheim Pharmacal, Inc.
Effective date
2016-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DULOXETINE DELAYED-RELEASE - Blenheim Pharmacal, Inc.Blenheim Pharmacal, Inc.2016-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62034-021-772020-01-31C16284748780-19d75b9d1-1c92-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Duloxetine Delayed-release Capsules safely and effectively. See full prescribing information for Duloxetine Delayed-release Capsules. DULOXETINE delayed-release capsules USP for oral use. Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62034-021-11DULOXETINEDELAYED-RELEASE1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS14
62034-021-77DULOXETINEDELAYED-RELEASE100 in 1 BOX, UNIT-DOSECAPSULE, DELAYED RELEASE PELLETS1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62034-021DULOXETINE DELAYED-RELEASE (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE PELLETS [BLENHEIM PHARMACAL, INC.]4Legacy NDC, 2 package rows20160607_c49f4fe2-1a2f-46fd-9dd1-45d54fdd1d75.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 66 of 117 · 2,325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
unii: 15FIX9V2JP
Duloxetine D/RDULOXETINE D/RDirect_Rx3ac53025-8a99-31de-e063-6294a90a53d22025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 596926
unii: 9044SC542W
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
unii: 15FIX9V2JP
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
unii: 15FIX9V2JP
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsSMELLING SALTSShenzhen Weikeduo E-commerce Co., Ltd.377fa82a-dcbe-9ab6-e063-6394a90a63842025-07-18WarningsExact identifier
unii: 5138Q19F1X
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
unii: 15FIX9V2JP
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
unii: 15FIX9V2JP
Gluvelop SMELLING SALTSSMELLING SALTSShenzhen Nanjun Technology Co., Ltd398c26ec-5eba-1202-e063-6294a90a76c92025-07-09WarningsExact identifier
unii: 5138Q19F1X
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
unii: 15FIX9V2JP
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
MELAO WHITENING SUNSCREENTITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd1aaf5942-ff13-ee07-e063-6394a90acd282025-06-25WarningsExact identifier
unii: 15FIX9V2JP
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
unii: 15FIX9V2JP
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
unii: 15FIX9V2JP
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
unii: 15FIX9V2JP
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact identifier
unii: 15FIX9V2JP
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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