Home NDC 70518-1483-0 PREZISTA
Product NDC 70518-1483
Requested package NDC 70518-1483-0
11-digit product format 705181483
Labeler code 70518
Product ID 70518-1483_e452a5dd-4223-0f44-e053-2a95a90a6b06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name darunavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021976
Marketing category NDA
Marketing start 2018-10-06
Marketing end 0000-00-00
Substance DARUNAVIR ETHANOLATE
Active strength 800 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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date N021976-001 PREZISTA DARUNAVIR 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-06-23 N021976-002 PREZISTA DARUNAVIR 600MG TABLET / ORAL AB RLD 2008-02-25 N021976-003 PREZISTA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 · 252 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 2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-002 PREZISTA 600MG TABLET / ORAL AB RLD 2008-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-004 PREZISTA 75MG TABLET / ORAL AB RLD 2008-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-005 PREZISTA 150MG TABLET / ORAL AB RLD 2008-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-006 PREZISTA 800MG TABLET / ORAL AB RLD, RS 2012-11-09 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 79 observed states.
Observed Orange Book patent history# Patent history page 1 of 28 · 1,100 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N021976-001 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-001 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-002 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-002 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-003 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-003 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-004 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-004 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-005 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-005 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-006 7700645 2026-12-26 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021976-006 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…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…
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70518-1483-0 70518148300 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1483-0) 2018-10-06 0000-00-00 No No Current