FDA.reportPublic FDA data

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:18:24

Label at a glance#

ProductEmtricitabine and tenofovir disoproxil fumarate
Active ingredientEMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1620-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg

Rx Only

30 tablets

MFG label
MFG label

NDC 70771-1621-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 133 mg/200 mg

Rx Only

30 tablets

MFG label
MFG label

NDC 70771-1622-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 167 mg/250 mg

Rx Only

30 tablets

MFG label
MFG label

NDC 70771-1709-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

Rx Only

30 tablets

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletPSN6
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletPSN6
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletPSN6
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN6
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral TabletSCD6
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral TabletSCD6
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral TabletSCD6
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD6
1744001emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY6
1744005emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY6
1744009emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY6
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EMTRICITABINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20200302
TENOFOVIR ANHYDROUS Pharmacologic Class Indexing6Indexing - Pharmacologic Class20200302

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1620-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED106
70771-1620-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED306
70771-1620-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED106
70771-1620-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED906
70771-1621-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED106
70771-1621-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED306
70771-1621-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED106
70771-1621-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED906
70771-1622-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED106
70771-1622-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED306
70771-1622-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED106
70771-1622-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED906
70771-1709-2Emtricitabine and tenofovir disoproxil fumarate10 in 1 BLISTER PACKTABLET, FILM COATED106
70771-1709-3Emtricitabine and tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED306
70771-1709-4Emtricitabine and tenofovir disoproxil fumarate10 in 1 CARTONTABLET, FILM COATED106
70771-1709-9Emtricitabine and tenofovir disoproxil fumarate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1620EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 4 package rows20241201_a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3.zip
70771-1621EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 4 package rows20241201_a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3.zip
70771-1622EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 4 package rows20241201_a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3.zip
70771-1709EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 4 package rows20241201_a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-162070771-1620-3, 70771-1620-9, 70771-1620-2, 70771-1620-4
70771-162170771-1621-3, 70771-1621-2, 70771-1621-4, 70771-1621-9
70771-162270771-1622-3, 70771-1622-9, 70771-1622-2, 70771-1622-4
70771-170970771-1709-3, 70771-1709-9, 70771-1709-2, 70771-1709-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
EMTRICITABINEG70B4ETF4SACTIB
TENOFOVIR DISOPROXIL FUMARATEOTT9J7900IACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GLYCERYL MONOCAPRYLOCAPRATEG7515SW10NIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
KAOLIN24H4NWX5COIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
EMTRICITABINEG70B4ETF4SACTIB
TENOFOVIR DISOPROXIL FUMARATEOTT9J7900IACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GLYCERYL MONOCAPRYLOCAPRATEG7515SW10NIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
KAOLIN24H4NWX5COIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
EMTRICITABINEG70B4ETF4SACTIB
TENOFOVIR DISOPROXIL FUMARATEOTT9J7900IACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GLYCERYL MONOCAPRYLOCAPRATEG7515SW10NIACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
KAOLIN24H4NWX5COIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
EMTRICITABINEG70B4ETF4SACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28
A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01
A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01
A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A212689-001AB
A212689-002AB
A212689-003AB
A212689-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28c2088c7a36db…
2026-10-15 13:18:302026-09A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01c2088c7a36db…
2026-10-15 13:18:302026-09A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01c2088c7a36db…
2026-09-14 22:38:342026-08A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-2884e616aacf4f…
2026-09-14 22:38:342026-08A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-0184e616aacf4f…
2026-09-14 22:38:342026-08A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212689-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2020-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212689-002EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALAB2021-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212689-003EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALAB2021-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212689-004EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALAB2021-07-012680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A212689-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A212689-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A212689-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A212689-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A212689-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212689-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A212689-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A212689-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A212689-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212689-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212689-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212689-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212689-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212689-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212689-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212689-004AB1fd3edfee7708…
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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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEZydus Lifesciences Limiteda0ee89b6-72c3-4b99-8d1c-d7473f1d5ef32024-11-28Exact identifier
ndc (package): 70771-1621-2
ndc (package): 70771-1620-9
ndc (package): 70771-1621-4
ndc (package): 70771-1620-3
ndc (package): 70771-1620-4
ndc (package): 70771-1622-9
ndc (package): 70771-1622-2
ndc (package): 70771-1709-9
ndc (package): 70771-1709-4
ndc (package): 70771-1709-3
ndc (package): 70771-1621-9
ndc (package): 70771-1622-3
ndc (package): 70771-1621-3
ndc (package): 70771-1622-4
ndc (package): 70771-1620-2
ndc (package): 70771-1709-2
ndc (product): 70771-1620
ndc (product): 70771-1709
ndc (product): 70771-1622
ndc (product): 70771-1621
ndc11 (package): 70771162202
ndc11 (package): 70771162004
ndc11 (package): 70771162003
ndc11 (package): 70771170903
ndc11 (package): 70771170904
ndc11 (package): 70771162203
ndc11 (package): 70771162102
ndc11 (package): 70771162209
ndc11 (package): 70771170909
ndc11 (package): 70771162103
ndc11 (package): 70771162009
ndc11 (package): 70771162002
ndc11 (package): 70771162204
ndc11 (package): 70771162104
ndc11 (package): 70771162109
ndc11 (package): 70771170902
spl id: 8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6
spl set id: a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3

Reported adverse events (FAERS/openFDA)#

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