Home NDC 61958-1401 Tybost
Product NDC 61958-1401
11-digit product format 619581401
Labeler code 61958
Product ID 61958-1401_169d8571-3b28-4b3b-8def-18316f1297f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COBICISTAT
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA203094
Marketing category NDA
Marketing start 2014-09-24
Marketing end 2028-03-31
Substance COBICISTAT
Active strength 150 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 61958-1401 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61958-1401 61958-1401-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203094-001 TYBOST COBICISTAT 150MG TABLET / ORAL RLD 2014-09-24 N203094-002 TYBOST COBICISTAT 90MG TABLET / ORAL RLD 2025-06-20
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 N203094-001 8148374*PED 2030-03-03 Pediatric extension N203094-001 10039718 2032-10-06 Drug product 2018-09-04 N203094-001 10039718*PED 2033-04-06 Pediatric extension N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 N203094-002 8148374*PED 2030-03-03 Pediatric extension N203094-002 10039718 2032-10-06 Drug product 2025-07-15 N203094-002 10039718*PED 2033-04-06 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N203094-001 ODE-260 2026-08-22
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 · 45 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 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 TYBOST 90MG TABLET / ORAL RLD 2025-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203094-001 TYBOST 150MG TABLET / ORAL AB RLD, RS 2014-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203094-001 TYBOST 150MG TABLET / ORAL RLD, RS 2014-09-24 3a93d1ddd44b…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 164 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 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-001 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 8148374*PED 2030-03-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203094-002 10039718*PED 2033-04-06 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 8148374*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-001 10039718*PED 2033-04-06 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 8148374*PED 2030-03-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203094-002 10039718*PED 2033-04-06 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 8148374*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-001 10039718*PED 2033-04-06 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 8148374 2029-09-03 U-1279 Drug substance, Drug product 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 8148374*PED 2030-03-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 10039718 2032-10-06 Drug product 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203094-002 10039718*PED 2033-04-06 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 8148374*PED 2030-03-03 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203094-001 10039718*PED 2033-04-06 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 8148374*PED 2030-03-03 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203094-001 10039718*PED 2033-04-06 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 8148374*PED 2030-03-03 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203094-001 10039718*PED 2033-04-06 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2014-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 8148374*PED 2030-03-03 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 10039718 2032-10-06 Drug product 2018-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203094-001 10039718*PED 2033-04-06 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 55 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tybost Active Ingredients# Ingredient, Strength table Ingredient Strength COBICISTAT 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LW2E03M5PG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1551993 Internal RxNorm lookup 1551999 Internal RxNorm lookup 2719618 Internal RxNorm lookup 2719620 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 61958-1401-1 Tybost 30 in 1 BOTTLE TABLET, FILM COATED 30 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COBICISTAT ACTIVE INGREDIENT LW2E03M5PG TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 COBICISTAT ACTIVE MOIETY LW2E03M5PG TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-1401 TYBOST (COBICISTAT) TABLET, FILM COATED [GILEAD SCIENCES, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20250119_3784c35c-e87f-410c-900b-8fd6313c6010.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.
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 61958-1401-1 61958140101 30 TABLET, FILM COATED in 1 BOTTLE (61958-1401-1) 2014-09-24 2028-03-31 No No Current