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 59 of 118 · 2,354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHTTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesa7f906f6-3041-4c24-955d-90cdd402dd022025-11-03WarningsExact identifier
unii: 15FIX9V2JP
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bc865f-29bd-da90-e063-6294a90aa16d2025-11-03WarningsExact identifier
unii: 15FIX9V2JP
Biopo Facial Mineral Sunscreen- Tinted SPF 40BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40Guangzhou Ariel Biotech Co., Ltd.42bd8bce-2959-266a-e063-6394a90a9a412025-11-03WarningsExact identifier
unii: 15FIX9V2JP
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
DuloxetineDULOXETINE HYDROCHLORIDEQuallent Pharmaceuticals Health, LLC31362045-201f-45f3-99f2-a5e322a0c30b2025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203088
rxcui: 596926
rxcui: 596930
rxcui: 616402
rxcui: 596934
unii: 9044SC542W
e l f Camo Semi Matte CC SPF 30 Light 205 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.055878ef-c671-4d65-9639-bda5a1dc30292025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 120 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b6b18a13-1f22-4061-91f5-852f7a487c032025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 100 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.d7815651-6b14-41f6-90cd-0a5b0b4a12ac2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 140 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.59331429-5fe0-4671-aabd-ec20640dd3ee2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Fair 125 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.c6ef3b07-babf-401d-a241-4e81e162c9652025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 330 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.c6d4b851-bf09-4177-b473-a2378c55ceec2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 210 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2f151e6c-ab2d-40cb-a67c-e067147ed7022025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 280 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6b0b9204-f205-415b-bd16-1970958b8be72025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 240 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8c12a34c-f648-4b55-8265-d430c72ae2052025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Light 250 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 370 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8d4862e-2671-4b85-8338-f935e0d0194f2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 310 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8d53abee-73bc-4268-b08d-0c196ff4d8522025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Medium 375 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1de296f5-276b-4e8f-8db2-78ea01965c4a2025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 610 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.75543b93-8ed9-4c7b-9fcf-99745df5a1942025-10-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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