Home NDC 70518-0689 PREZISTA
Product NDC 70518-0689
11-digit product format 705180689
Labeler code 70518
Product ID 70518-0689_6818b4b6-ba19-d852-e053-2991aa0a87c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name darunavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021976
Marketing category NDA
Marketing start 2017-08-21
Marketing end 0000-00-00
Substance DARUNAVIR ETHANOLATE
Active strength 600 mg/1
Pharmacologic classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-0689-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-0689-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-0689-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-0689-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-0689-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-0689-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-0689-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-0689-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-0689-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-0689-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-0689-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-0689-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021976-001 PREZISTA DARUNAVIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 N021976-002 PREZISTA DARUNAVIR 600MG TABLET / ORAL AB RLD 2008-02-25 N021976-003 PREZISTA DARUNAVIR 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 N021976-004 PREZISTA DARUNAVIR 75MG TABLET / ORAL AB RLD 2008-12-18 N021976-005 PREZISTA DARUNAVIR 150MG TABLET / ORAL AB RLD 2008-12-18 N021976-006 PREZISTA DARUNAVIR 800MG TABLET / ORAL AB RLD, RS 2012-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021976-001 7700645 2026-12-26 Drug substance, Drug product N021976-001 7700645*PED 2027-06-26 Pediatric extension N021976-002 7700645 2026-12-26 Drug substance, Drug product N021976-002 7700645*PED 2027-06-26 Pediatric extension N021976-003 7700645 2026-12-26 Drug substance, Drug product N021976-003 7700645*PED 2027-06-26 Pediatric extension N021976-004 7700645 2026-12-26 Drug substance, Drug product N021976-004 7700645*PED 2027-06-26 Pediatric extension N021976-005 7700645 2026-12-26 Drug substance, Drug product N021976-005 7700645*PED 2027-06-26 Pediatric extension N021976-006 7700645 2026-12-26 Drug substance, Drug product N021976-006 7700645*PED 2027-06-26 Pediatric extension
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 7 · 246 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 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-005 PREZISTA 150MG TABLET / ORAL RLD 2008-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-001 PREZISTA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-003 PREZISTA 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2008-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021976-004 PREZISTA 75MG TABLET / ORAL RLD 2008-12-18 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 75 observed states.
Observed Orange Book patent history# Patent history page 1 of 28 · 1,088 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 N021976-001 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-001 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-002 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-003 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-004 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-005 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 7700645 2026-12-26 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021976-006 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-001 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-002 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-003 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-004 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-005 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 7700645 2026-12-26 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021976-006 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021976-001 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-001 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-002 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-003 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-004 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-005 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 7700645 2026-12-26 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021976-006 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 7700645 2026-12-26 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-001 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 7700645 2026-12-26 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021976-002 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…
FDA-Initiated Inactive NDC Indexing# 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 PREZISTA DARUNAVIR Janssen Products LP 814301f9-c990-46a5-b481-2879a521a16f 2025-08-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 021976 application number: NDA021976