Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
0904-7172
11-digit product format
009047172
Labeler code
0904
Product ID
0904-7172_e3e2c3b9-806a-4639-ab44-5c5b4bb1166e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212114
Marketing category
ANDA
Marketing start
2019-07-26
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200; 300 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212114-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2019-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2019-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2019-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2019-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORAL2019-07-26b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212114-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2019-07-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212114-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212114-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212114-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212114-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212114-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212114-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212114-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212114-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212114-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212114-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212114-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212114-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212114-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212114-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212114-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212114-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212114-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212114-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212114-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212114-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212114-001AB15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212114-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212114-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212114-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212114-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212114-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212114-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212114-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212114-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212114-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212114-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212114-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212114-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212114-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212114-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Emtricitabine and Tenofovir Disoproxil Fumarate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE200 mg/1
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G70B4ETF4SInternal UNII lookup
OTT9J7900IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476556Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a78b51c9-c944-4b00-af81-9ecbfbb29fd1Available on FDA.report

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
0904-7172-07Emtricitabine and Tenofovir Disoproxil Fumarate30 in 1 CARTONTABLET, FILM COATED306
0904-7172-07Emtricitabine and Tenofovir Disoproxil Fumarate1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7172-07EA - Each0904-71722475b5b1-b16b-475d-9bfe-919d00068d3712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7172EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250206_a78b51c9-c944-4b00-af81-9ecbfbb29fd1.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEMajor Pharmaceuticalsa78b51c9-c944-4b00-af81-9ecbfbb29fd12026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212114
application number: ANDA212114
ndc (product): 0904-7172
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENuCare Pharmaceuticals, Inc.4feb83a5-9142-0c67-e063-6394a90a710f2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212114
application number: ANDA212114
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepackb8c5f114-61db-4797-b75e-c103d2d1820e2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212114
application number: ANDA212114
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATELaurus Labs Limited4a7ccbbf-da20-4012-9717-31c411efb3fb2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212114
application number: ANDA212114
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions7bf86d9d-999a-4b64-849a-0d43bbf7b7662024-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212114
application number: ANDA212114

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSNa78b51c9-c944-4b00-af81-9ecbfbb29fd16
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCDa78b51c9-c944-4b00-af81-9ecbfbb29fd16
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYa78b51c9-c944-4b00-af81-9ecbfbb29fd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7172-070090471720730 BLISTER PACK in 1 CARTON (0904-7172-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2019-07-260000-00-00NoNoCurrent