FDA.reportPublic FDA data

NDC 70710-1367-2 - 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
70710-1367
Requested NDC
70710-1367-2
Package NDCs from labels
70710-1367-3, 70710-1367-9, 70710-1367-2, 70710-1367-4
Manufacturer
American Health Packaging
Effective date
2025-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Emtricitabine and tenofovir disoproxil fumarate - American Health PackagingAmerican Health Packaging2025-07-18HUMAN PRESCRIPTION DRUG LABEL
CROSCARMELLOSE SODIUM - Redpharm Drug, Inc. | Zydus Pharmaceuticals USA Inc.Redpharm Drug, Inc. | Zydus Pharmaceuticals USA Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL
Emtricitabine and tenofovir disoproxil fumarate - Pharmasource Meds, LLCPharmasource Meds, LLC2024-05-28HUMAN PRESCRIPTION DRUG LABEL
EMTRICITABINE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-05-10HUMAN PRESCRIPTION DRUG LABEL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE - DIRECT RXDIRECT RX2021-06-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1367-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED108
70710-1367-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED308
70710-1367-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED108
70710-1367-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1367EMTRICITABINE 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
70710-1367-3EA - Each70710-136728235e35-38d8-4c3a-9b02-76efaaaa3ac012021-04-08

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 86 of 108 · 2,148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
unii: 15FIX9V2JP
198b975a-455e-116c-e063-6394a90aec10fe0d4bf9-fddd-6722-e053-6294a90aa9f32024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 198b975a-455e-116c-e063-6394a90aec10
spl set id: fe0d4bf9-fddd-6722-e053-6294a90aa9f3
Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATETeva Pharmaceuticals USA, Inc.fc9c2149-8d40-401b-af13-5ae7f953950a2024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
unii: G70B4ETF4S
COOLA Mineral Liplux Lip Balm SPF 30 Nude BeachTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee2842c3-65e0-3904-e053-2a95a90aabff2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 FirecrackerTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee026a1c-885b-256f-e053-2a95a90af5642024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla CocoTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCec96dee8-85e8-3147-e053-2995a90aaf532024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze GoddessTITANIUM DIOXIDECOOLA, LLCeeb406c6-a543-379a-e053-2995a90a49982024-05-22WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh RoseTITANIUM DIOXIDECOOLA, LLCee01642f-478e-b307-e053-2a95a90a7d812024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Matte Untinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCecabcc89-fb09-41a9-e053-2995a90a8b312024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Matte Tinted Face SPF 30TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCee018c21-dca7-28aa-e053-2a95a90a3bdb2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Golden DazeTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeeb70034-0f8d-a46d-e053-2a95a90a81302024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Diamond DustTITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCeec83ecb-d0ab-7857-e053-2995a90a40ed2024-05-22WarningsExact identifier
unii: 15FIX9V2JP
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
unii: 15FIX9V2JP
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions7bf86d9d-999a-4b64-849a-0d43bbf7b7662024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 476556
unii: OTT9J7900I
unii: G70B4ETF4S
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEZydus Pharmaceuticals USA Inc.7def7a95-e69e-4985-974a-efacadcecc952024-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212689
ndc (package): 70710-1366-3
ndc (package): 70710-1365-4
ndc (package): 70710-1366-2
ndc (package): 70710-1366-9
ndc (package): 70710-1367-9
ndc (package): 70710-1367-2
ndc (package): 70710-1364-2
ndc (package): 70710-1365-3
ndc (package): 70710-1367-3
ndc (package): 70710-1366-4
ndc (package): 70710-1364-9
ndc (package): 70710-1367-4
ndc (package): 70710-1365-9
ndc (package): 70710-1364-4
ndc (package): 70710-1365-2
ndc (package): 70710-1364-3
ndc (product): 70710-1366
ndc (product): 70710-1365
ndc (product): 70710-1367
ndc (product): 70710-1364
ndc11 (package): 70710136702
rxcui: 1744009
rxcui: 476556
rxcui: 1744001
rxcui: 1744005
spl id: 919c0aaa-f6d2-426d-a673-ef5c806f9a3a
spl set id: 7def7a95-e69e-4985-974a-efacadcecc95
unii: OTT9J7900I
unii: G70B4ETF4S
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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