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 87 of 108 · 2,148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Efavirenz, Lamivudine and Tenofovir Disoproxil FumarateEFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATELaurus Labs Limited98342153-b9de-4318-aac4-9f8d19590cd72024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
BiktarvyBICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATEA-S Medication Solutions0476d7eb-1024-4821-bbe7-abaacfda32a22024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G70B4ETF4S
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
unii: 24H4NWX5CO
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TopazTITANIUM DIOXIDEChantecaille Beaute Inc2012f671-7889-4e29-b70f-215cbc9dbdc72024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 VanillaTITANIUM DIOXIDEChantecaille Beaute Inc7133c47d-ed1c-43e9-8cdf-42f7b2f215f52024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Alumina silicataKAOLINBoiron83ea8d43-c4d9-c9e2-e053-2991aa0af0802024-04-24Exact identifier
unii: 24H4NWX5CO
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGolden State Medical Supply, Inc.bdd87563-251a-d990-e053-2a95a90ad5782024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 476556
unii: OTT9J7900I
unii: G70B4ETF4S

Reported adverse events (FAERS/openFDA)#

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