Home NDC 61958-0705 Truvada
Product NDC 61958-0705
11-digit product format 619580705
Labeler code 61958
Product ID 61958-0705_32422ee8-1cdc-4305-bb3e-0458472513fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc
Application NDA021752
Marketing category NDA
Marketing start 2016-03-10
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 167; 250 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021752-001 TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 N021752-002 TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 N021752-003 TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 N021752-004 TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET / ORAL AB RLD 2016-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021752-001 TRUVADA 200MG;300MG TABLET / ORAL AB RLD, RS 2004-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-002 TRUVADA 100MG;150MG TABLET / ORAL AB RLD 2016-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-003 TRUVADA 133MG;200MG TABLET / ORAL AB RLD 2016-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-004 TRUVADA 167MG;250MG TABLET / ORAL AB RLD 2016-03-10 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 146 observed states.
Observed Orange Book patent history# Patent history page 1 of 10 · 390 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 8592397 2024-01-13 U-248 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 8592397 2024-01-13 U-541 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 8592397 2024-01-13 U-1170 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 8592397 2024-01-13 U-248 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 8592397 2024-01-13 U-541 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 8592397 2024-01-13 U-1170 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 8592397 2024-01-13 U-248 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 8592397 2024-01-13 U-541 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 8592397 2024-01-13 U-1170 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 8592397 2024-01-13 U-248 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 8592397 2024-01-13 U-541 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 8592397 2024-01-13 U-1170 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021752-001 8592397 2024-01-13 U-248 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-001 8592397 2024-01-13 U-541 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-001 8592397 2024-01-13 U-1170 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 8592397 2024-01-13 U-248 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 8592397 2024-01-13 U-541 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 8592397 2024-01-13 U-1170 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 9457036 2024-01-13 U-257 Drug product 2016-11-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021752-001 9744181 2024-01-13 U-257 Drug product 2017-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021752-001 8592397 2024-01-13 U-248 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021752-001 8592397 2024-01-13 U-541 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021752-001 8592397 2024-01-13 U-1170 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021752-001 8716264 2024-01-13 U-257 Drug product 2014-05-30 301d65b070ca…
Additional Listing Data#
Finished product Yes
Brand name base Truvada
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 167 mg/1 TENOFOVIR DISOPROXIL FUMARATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OTT9J7900I Internal UNII lookup G70B4ETF4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476556 Internal RxNorm lookup 639888 Internal RxNorm lookup 1744001 Internal RxNorm lookup 1744003 Internal RxNorm lookup 1744005 Internal RxNorm lookup 1744007 Internal RxNorm lookup 1744009 Internal RxNorm lookup 1744011 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-0705-1 Truvada 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded emtricitabine ACTIVE INGREDIENT G70B4ETF4S TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 tenofovir disoproxil fumarate ACTIVE INGREDIENT OTT9J7900I TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 emtricitabine ACTIVE MOIETY G70B4ETF4S TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 tenofovir anhydrous ACTIVE MOIETY W4HFE001U5 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 aluminum oxide INACTIVE INGREDIENT LMI26O6933 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 starch, corn INACTIVE INGREDIENT O8232NY3SJ TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 triacetin INACTIVE INGREDIENT XHX3C3X673 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19 water INACTIVE INGREDIENT 059QF0KO0R TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-0705 TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] 31 Current NDC, Legacy NDC, 1 package rows 20240524_54e82b13-a037-49ed-b4b3-030b37c0ecdd.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61958-0705-1 61958070501 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0705-1) 2016-03-10 0000-00-00 No No Current