Home NDC 61958-1101 COMPLERA
Product NDC 61958-1101
11-digit product format 619581101
Labeler code 61958
Product ID 61958-1101_21d7850d-11ea-43cc-84a5-0dae02a19ce6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA202123
Marketing category NDA
Marketing start 2011-08-10
Substance EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 200; 25; 300 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202123-001 COMPLERA EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202123-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202123-001 10857102 2033-01-14 Drug product 2021-01-06
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 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 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL AB RLD, RS 2011-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202123-001 COMPLERA 200MG;EQ 25MG BASE;300MG TABLET / ORAL RLD, RS 2011-08-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202123-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202123-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 9 · 341 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 8592397 2024-01-13 U-257 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 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 N202123-001 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 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 8592397 2024-01-13 U-257 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 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 N202123-001 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 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 8592397 2024-01-13 U-257 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 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 N202123-001 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 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202123-001 10857102 2033-01-14 Drug product 2021-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 8592397 2024-01-13 U-257 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 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 N202123-001 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 N202123-001 9744181 2024-01-13 U-257 Drug product 2017-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 7125879 2025-04-21 U-257 Drug substance, Drug product 2011-09-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202123-001 8841310 2025-12-09 U-257 Drug product 2014-10-20 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base COMPLERA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EMTRICITABINE 200 mg/1 RILPIVIRINE HYDROCHLORIDE 25 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup 212WAX8KDD Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147334 Internal RxNorm lookup 1147337 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 61958-1101-1 2024-09-25 C162847 48780-1 ab0e2407-3575-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA ® (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011 61958-1101-1 2024-07-30 C162847 48780-1 ab0e2407-3575-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA ® (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011 61958-1101-1 2020-07-22 C162847 48780-1 ab0e2407-3575-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA ® (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2011
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-1101-1 COMPLERA 30 in 1 BOTTLE TABLET, FILM COATED 30 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded emtricitabine ACTIVE INGREDIENT G70B4ETF4S COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 rilpivirine hydrochloride ACTIVE INGREDIENT 212WAX8KDD COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 tenofovir disoproxil fumarate ACTIVE INGREDIENT OTT9J7900I COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 emtricitabine ACTIVE MOIETY G70B4ETF4S COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 rilpivirine ACTIVE MOIETY FI96A8X663 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 tenofovir anhydrous ACTIVE MOIETY W4HFE001U5 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 aluminum oxide INACTIVE INGREDIENT LMI26O6933 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 Povidones INACTIVE INGREDIENT FZ989GH94E COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 starch, corn INACTIVE INGREDIENT O8232NY3SJ COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 triacetin INACTIVE INGREDIENT XHX3C3X673 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 11 emtricitabine ACTIVE INGREDIENT G70B4ETF4S COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 rilpivirine hydrochloride ACTIVE INGREDIENT 212WAX8KDD COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 tenofovir disoproxil fumarate ACTIVE INGREDIENT OTT9J7900I COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 emtricitabine ACTIVE MOIETY G70B4ETF4S COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 rilpivirine ACTIVE MOIETY FI96A8X663 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 tenofovir anhydrous ACTIVE MOIETY W4HFE001U5 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 Povidones INACTIVE INGREDIENT FZ989GH94E COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 triacetin INACTIVE INGREDIENT XHX3C3X673 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-1101 COMPLERA (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 20 Current NDC, Legacy NDC, 1 package rows 20240927_d637cfab-f1e8-4eb3-a1b3-f85ca3bec612.zip
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Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COMPLERA EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE Gilead Sciences, Inc. d637cfab-f1e8-4eb3-a1b3-f85ca3bec612 2025-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202123 application number: NDA202123 ndc (product): 61958-1101
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 61958-1101-1 61958110101 30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1) 2011-08-10 0000-00-00 No No Current