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 62 of 108 · 2,144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COMPLERAEMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.d637cfab-f1e8-4eb3-a1b3-f85ca3bec6122025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
unii: G70B4ETF4S
TruvadaEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc54e82b13-a037-49ed-b4b3-030b37c0ecdd2025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1744009
rxcui: 476556
rxcui: 1744001
rxcui: 1744005
unii: OTT9J7900I
unii: G70B4ETF4S
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
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEAvKARE38e06005-b998-9abb-e063-6294a90a71cb2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 476556
unii: OTT9J7900I
unii: G70B4ETF4S
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEToshiki Pigment Co., ltd.b7162a2f-07f1-6188-e053-2995a90a8a9c2025-06-27WarningsExact identifier
unii: 15FIX9V2JP
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
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
unii: 15FIX9V2JP
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
unii: 15FIX9V2JP
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
unii: 15FIX9V2JP
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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