Home NDC 59676-800 Symtuza
Product NDC 59676-800
11-digit product format 596760800
Labeler code 59676
Product ID 59676-800_a8468da1-a6e7-4a14-a108-23915ccaeee8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Products LP
Application NDA210455
Marketing category NDA
Marketing start 2018-07-17
Substance COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
Active strength 150; 800; 200; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], 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], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N210455-001 SYMTUZA COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 N210455-001 10786518 2038-07-19 U-2978 2020-10-28
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 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210455-001 SYMTUZA 150MG;EQ 800MG BASE;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210455-001 SYMTUZA 150MG;EQ 800MG BASE;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210455-001 SYMTUZA 150MG;800MG;200MG;EQ 10MG BASE TABLET / ORAL RLD, RS 2018-07-17 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 17 · 644 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 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210455-001 10786518 2038-07-19 U-2978 2020-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 7390791 2025-04-17 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210455-001 10786518 2038-07-19 U-2978 2020-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210455-001 7390791 2025-04-17 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 7700645 2026-12-26 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2353 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2767 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2768 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2766 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2364 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8148374 2029-09-03 U-2365 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8754065 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 8754065 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 9296769 2032-08-15 U-2352 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 9296769 2032-08-15 U-2765 Drug substance, Drug product 2018-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210455-001 10039718 2032-10-06 Drug product 2018-09-05 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Symtuza
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR 150 mg/1 COBICISTAT 800 mg/1 EMTRICITABINE 200 mg/1 TENOFOVIR ALAFENAMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2049671 Internal RxNorm lookup 2049677 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 59676-800-30 2020-07-22 C162847 48780-1 ab0e2407-3409-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA. SYMTUZA ® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 59676-800-99 2020-07-22 C162847 48780-1 ab0e2407-3409-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use SYMTUZA safely and effectively. See full prescribing information for SYMTUZA. SYMTUZA ® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59676-800-30 Symtuza 30 in 1 BOTTLE TABLET, FILM COATED 30 23 59676-800-99 Symtuza 30 in 1 BOTTLE TABLET, FILM COATED 30 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59676-800 SYMTUZA (DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 22 Current NDC, Legacy NDC, 2 package rows 20240724_85a17d00-6b7c-41ea-a6b3-5ad924820dab.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Symtuza DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE Janssen Products LP 85a17d00-6b7c-41ea-a6b3-5ad924820dab 2026-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210455 application number: NDA210455 ndc (product): 59676-800
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 59676-800-30 59676080030 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) 2018-07-17 0000-00-00 No No Current 59676-800-99 59676080099 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) 2018-07-17 0000-00-00 Yes No Current