FDA.reportPublic FDA data

NDC 70710-1365-2 - Emtricitabine and tenofovir disoproxil fumarate

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
70710-1365
Requested NDC
70710-1365-2
Package NDCs from labels
70710-1365-3, 70710-1365-2, 70710-1365-4, 70710-1365-9
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2024-05-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EMTRICITABINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-05-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1365-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED108
70710-1365-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED308
70710-1365-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED108
70710-1365-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1365EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 4 package rows20240518_7def7a95-e69e-4985-974a-efacadcecc95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1365-3EA - Each70710-13650ad390b6-b292-4401-a209-b7d2c10e0f3312021-08-05

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 76 of 108 · 2,144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer TintTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inca1cab79d-0151-49ee-86dc-c2739842e62e2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Even Up Sunscreen SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef9d375af-3c8b-4462-b729-fdd4be9292842024-12-17WarningsExact identifier
unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.dc6b28ca-b922-460a-8028-fb3f5afdbe9d2024-12-16WarningsExact identifier
unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.1f9a4b71-45aa-4156-9fe6-ffa81f808a852024-12-16WarningsExact identifier
unii: 15FIX9V2JP
Natural Finish Pressed Foundation SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColoresciencec389e183-bfad-4813-af09-fae3aa05e82a2024-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunforgettable Total Protection Brush-On Shield SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencec77357f1-7ada-4325-86f7-5ee801610f422024-12-16WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine, Rilpivirine, Tenofovir Disoproxil FumarateEMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATEMylan Pharmaceuticals Inc.d9a4185e-43fa-4aeb-9b0f-8db01b1660382024-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
unii: G70B4ETF4S
WEIGHTLESS SKIN FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.fbd04b66-738b-2762-e053-6394a90a8b722024-12-13WarningsExact identifier
unii: 15FIX9V2JP
Calming Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienced681cdb5-307e-4a2a-8e1d-2b29131d48d02024-12-13WarningsExact identifier
unii: 15FIX9V2JP
Mineral Corrector Palette SPF 20 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescienceab70122f-bd68-4781-841f-dc83284e14032024-12-13WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Healthy Skin Radiant Tinted Moisturizer Sunscreen Broad Spectrum SPF 25, Sheer Ivory 10TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC0a0654cc-ad47-2167-e063-6294a90a52f42024-12-12WarningsExact identifier
unii: 15FIX9V2JP
Babo Botanicals Daily Sheer Mineral Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEBabo Botanicals, Inc.f8adda52-e909-1905-e053-6294a90a3c782024-12-12WarningsExact identifier
unii: 15FIX9V2JP
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural GlowMINERAL SUNSCREENBabo Botanicals, Inc.ab39d9f0-d869-6f33-e053-2995a90a08d42024-12-12WarningsExact identifier
unii: 15FIX9V2JP
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
unii: 15FIX9V2JP
All Calm Clinical Redness Corrector SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColorescience68b95e94-3686-4d11-9952-ec86394376ee2024-12-12WarningsExact identifier
unii: 15FIX9V2JP
Sunforgettable Tint du Soleil Foundation SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescience219e2ef4-e977-4527-8999-14b27d5a7a332024-12-12WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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