Home NDC 59676-575-30 PREZCOBIX
Product NDC 59676-575
Requested package NDC 59676-575-30
11-digit product format 596760575
Labeler code 59676
Product ID 59676-575_9d92f536-2a35-4d1d-baca-8d87e8b8dcaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DARUNAVIR ETHANOLATE and COBICISTAT
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Janssen Products, LP
Application NDA205395
Marketing category NDA
Marketing start 2015-01-31
Substance COBICISTAT; DARUNAVIR ETHANOLATE
Active strength 150; 800 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], 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], 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205395-001 PREZCOBIX COBICISTAT; DARUNAVIR ETHANOLATE 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 N205395-002 PREZCOBIX COBICISTAT; DARUNAVIR ETHANOLATE 150MG;EQ 675MG BASE TABLET / ORAL RLD, RS 2025-03-21
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 N205395-001 7700645*PED 2027-06-26 Pediatric extension N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 N205395-001 8148374 2029-09-03 U-4162 Drug substance, Drug product 2015-02-26 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 N205395-002 7700645 2026-12-26 Drug substance, Drug product 2025-04-16 N205395-002 7700645*PED 2027-06-26 Pediatric extension N205395-002 8148374 2029-09-03 U-4162 Drug substance, Drug product 2025-04-16 N205395-002 10039718 2032-10-06 Drug product 2025-04-16
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 N205395-001 PREZCOBIX 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-002 PREZCOBIX 150MG;EQ 675MG BASE TABLET / ORAL RLD 2025-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 PREZCOBIX 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-002 PREZCOBIX 150MG;EQ 675MG BASE TABLET / ORAL RLD 2025-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205395-001 PREZCOBIX 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-002 PREZCOBIX 150MG;EQ 675MG BASE TABLET / ORAL RLD 2025-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205395-001 PREZCOBIX 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205395-001 PREZCOBIX 150MG;EQ 800MG BASE TABLET / ORAL RLD, RS 2015-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205395-001 PREZCOBIX 150MG;800MG TABLET / ORAL RLD, RS 2015-01-29 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 8 · 311 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 N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-001 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-001 8148374 2029-09-03 U-4162 Drug substance, Drug product 2015-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-002 7700645 2026-12-26 Drug substance, Drug product 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-002 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-002 8148374 2029-09-03 U-4162 Drug substance, Drug product 2025-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205395-002 10039718 2032-10-06 Drug product 2025-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 8148374 2029-09-03 U-4162 Drug substance, Drug product 2015-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-002 7700645 2026-12-26 Drug substance, Drug product 2025-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-002 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-002 8148374 2029-09-03 U-4162 Drug substance, Drug product 2025-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205395-002 10039718 2032-10-06 Drug product 2025-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-001 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-001 8148374 2029-09-03 U-4162 Drug substance, Drug product 2015-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-002 7700645 2026-12-26 Drug substance, Drug product 2025-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-002 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-002 8148374 2029-09-03 U-4162 Drug substance, Drug product 2025-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205395-002 10039718 2032-10-06 Drug product 2025-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 7700645 2026-12-26 Drug substance, Drug product 2015-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 7700645*PED 2027-06-26 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 8148374 2029-09-03 U-2939 Drug substance, Drug product 2015-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205395-001 10039718 2032-10-06 Drug product 2018-09-05 b8a1b40f171c…
Additional Listing Data#
Finished product Yes
Brand name base PREZCOBIX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR ETHANOLATE 150 mg/1 COBICISTAT 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LW2E03M5PG Internal UNII lookup 33O78XF0BW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1600704 Internal RxNorm lookup 1600710 Internal RxNorm lookup 2710424 Internal RxNorm lookup 2710426 Internal RxNorm lookup 2738995 Internal RxNorm lookup 2738999 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 59676-575-30 PREZCOBIX 30 in 1 BOTTLE TABLET, FILM COATED 30 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COBICISTAT ACTIVE INGREDIENT LW2E03M5PG PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 DARUNAVIR ETHANOLATE ACTIVE INGREDIENT 33O78XF0BW PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 COBICISTAT ACTIVE MOIETY LW2E03M5PG PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 DARUNAVIR ACTIVE MOIETY YO603Y8113 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59676-575 PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP] 25 Current NDC, Legacy NDC, 1 package rows 20250406_9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f.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 59676-575-30 59676057530 30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30) 2015-01-31 0000-00-00 No No Current