Emtricitabine/TDF

Product NDC
72189-403
Requested package NDC
72189-403-03
11-digit product format
721890403
Labeler code
72189
Product ID
72189-403_2c4cdf7a-45da-784b-e063-6294a90a82b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine/TDF
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090513
Marketing category
ANDA
Marketing start
2022-12-05
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-40372189-403-03UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-40372189-403-03UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090513-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090513-001EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALAB2018-01-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090513-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090513-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090513-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090513-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090513-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090513-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090513-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090513-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090513-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090513-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090513-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090513-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090513-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090513-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090513-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090513-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090513-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090513-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090513-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090513-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090513-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090513-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090513-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090513-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090513-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090513-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090513-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090513-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090513-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090513-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090513-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090513-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090513-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090513-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090513-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090513-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090513-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090513-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090513-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090513-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Emtricitabine/TDF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE200 mg/1
EMTRICITABINE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OTT9J7900IInternal UNII lookup
G70B4ETF4SInternal 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
ef1a90ca-92bc-3787-e053-2a95a90a58ecAvailable 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
72189-403-03Emtricitabine/TDF3 in 1 BOTTLETABLET, FILM COATED34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-403-03EA - Each72189-403db8f8301-8d3d-47b5-aeed-d5228d9acc2412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-403EMTRICITABINE/TDF TABLET, FILM COATED [DIRECT_RX]4Current NDC, Legacy NDC, 1 package rows20250123_ef1a90ca-92bc-3787-e053-2a95a90a58ec.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Emtricitabine/TDFEMTRICITABINE/TDFDirect_Rxef1a90ca-92bc-3787-e053-2a95a90a58ec2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090513
application number: ANDA090513
ndc (package): 72189-403-03
ndc (product): 72189-403
ndc11 (package): 72189040303
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEProficient Rx LPd3b849a7-219d-4acc-9e29-8f246cb4a7a92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090513
application number: ANDA090513
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEQUALLENT PHARMACEUTICALS HEALTH LLC4af2529d-a14f-4337-87ed-04f8f27da7462024-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090513
application number: ANDA090513
Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limitedd8c32565-9ff2-4bfb-a5cf-ae6e0e498ccc2024-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090513
application number: ANDA090513

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSNef1a90ca-92bc-3787-e053-2a95a90a58ec4
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCDef1a90ca-92bc-3787-e053-2a95a90a58ec4
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYef1a90ca-92bc-3787-e053-2a95a90a58ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-403-03721890403033 TABLET, FILM COATED in 1 BOTTLE (72189-403-03) 2022-12-050000-00-00NoNoCurrent