Home NDC 59676-565 PREZISTA
Product NDC 59676-565
11-digit product format 596760565
Labeler code 59676
Product ID 59676-565_3d80bc62-24ac-c092-e063-6394a90a7bba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name darunavir
Dosage form SUSPENSION
Route ORAL
Labeler Janssen Products LP
Application NDA202895
Marketing category NDA
Marketing start 2011-12-16
Substance DARUNAVIR ETHANOLATE
Active strength 100 mg/mL
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N202895-001 PREZISTA DARUNAVIR 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 N202895-001 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 2 · 43 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 2026-09-14 22:38:34 2026-08 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202895-001 PREZISTA EQ 100MG BASE/ML SUSPENSION / ORAL RLD, RS 2011-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202895-001 PREZISTA EQ 100MG BASE/ML SUSPENSION / ORAL RLD, RS 2011-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202895-001 PREZISTA 100MG/ML SUSPENSION / ORAL RLD, RS 2011-12-16 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 5 · 184 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202895-001 7700645*PED 2027-06-26 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202895-001 7700645*PED 2027-06-26 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202895-001 7700645*PED 2027-06-26 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202895-001 7700645*PED 2027-06-26 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202895-001 7700645*PED 2027-06-26 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202895-001 7700645*PED 2027-06-26 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202895-001 7700645*PED 2027-06-26 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202895-001 8518987*PED 2024-08-16 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202895-001 7700645*PED 2027-06-26 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202895-001 8518987*PED 2024-08-16 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202895-001 7700645*PED 2027-06-26 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202895-001 8518987*PED 2024-08-16 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202895-001 7700645*PED 2027-06-26 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202895-001 8518987*PED 2024-08-16 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202895-001 7700645*PED 2027-06-26 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202895-001 8518987*PED 2024-08-16 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202895-001 7700645*PED 2027-06-26 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202895-001 8518987*PED 2024-08-16 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202895-001 7700645 2026-12-26 Drug substance, Drug product 2012-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202895-001 7700645*PED 2027-06-26 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202895-001 8518987 2024-02-16 Drug substance, Drug product 2013-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202895-001 8518987*PED 2024-08-16 Pediatric extension 301d65b070ca…
Additional Listing Data#
Finished product Yes
Brand name base PREZISTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DARUNAVIR ETHANOLATE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33O78XF0BW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 670026 Internal RxNorm lookup 794610 Internal RxNorm lookup 831868 Internal RxNorm lookup 831870 Internal RxNorm lookup 850455 Internal RxNorm lookup 850457 Internal RxNorm lookup 1236628 Internal RxNorm lookup 1236632 Internal RxNorm lookup 1359269 Internal RxNorm lookup 1359271 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 59676-565-01 PREZISTA 200 mL in 1 BOTTLE, GLASS SUSPENSION 200 58 59676-565-01 PREZISTA 1 in 1 CARTON SUSPENSION 1 58
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded darunavir ethanolate ACTIVE INGREDIENT 33O78XF0BW PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 darunavir ACTIVE MOIETY YO603Y8113 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 crospovidone INACTIVE INGREDIENT 68401960MK PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 METHYLPARABEN SODIUM INACTIVE INGREDIENT CR6K9C2NHK PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 talc INACTIVE INGREDIENT 7SEV7J4R1U PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31 WATER INACTIVE INGREDIENT 059QF0KO0R PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 31
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59676-565 PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] 57 Current NDC, Legacy NDC, 2 package rows 20240724_814301f9-c990-46a5-b481-2879a521a16f.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 59676-565-01 59676056501 1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS 2011-12-16 0000-00-00 No No Current