FDA.reportPublic FDA data

NDC 68071-4355-01 - Cephalexin

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
68071-4355
Requested NDC
68071-4355-01
Package NDCs from labels
68071-4355-4, 68071-4355-3, 68071-4355-7, 68071-4355-1, 68071-4355-8, 68071-4355-9, 68071-4355-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cephalexin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4355-42021-02-16C16284748780-1ba0f9c33-431d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
68071-4355-42021-01-29C16284748780-1ba0f9c33-431d-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4355-1Cephalexin21 in 1 BOTTLECAPSULE2110
68071-4355-3Cephalexin30 in 1 BOTTLECAPSULE3010
68071-4355-4Cephalexin14 in 1 BOTTLECAPSULE1410
68071-4355-7Cephalexin40 in 1 BOTTLECAPSULE4010
68071-4355-8Cephalexin28 in 1 BOTTLECAPSULE2810
68071-4355-9Cephalexin10 in 1 BOTTLECAPSULE1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4355CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]10Current NDC, Legacy NDC, 6 package rows20240608_681c235f-6dee-1401-e053-2991aa0addc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-4355-7EA - Each68071-4355fbeb737c-181b-4ead-a970-870d22983ef312021-04-08

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 50 of 144 · 2,870 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
unii: 15FIX9V2JP
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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