Home NDC 70518-0097-0 Truvada
Product NDC 70518-0097
Requested package NDC 70518-0097-0
11-digit product format 705180097
Labeler code 70518
Product ID 70518-0097_df38be31-b767-7143-e053-2995a90a05c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021752
Marketing category NDA
Marketing start 2016-12-30
Marketing end 0000-00-00
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Truvada EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE Gilead Sciences, Inc 54e82b13-a037-49ed-b4b3-030b37c0ecdd 2025-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021752 application number: NDA021752 Truvada EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE NuCare Pharmaceuticals,Inc. 46e06df0-654d-43cc-e054-00144ff8d46c 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021752 application number: NDA021752
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-0097-0 70518009700 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-0) 2016-12-30 0000-00-00 No No Current