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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202895-001	PREZISTA	100MG/ML	SUSPENSION / ORAL	RLD, RS	2011-12-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	7700645	2026-12-26	Drug substance, Drug product	2012-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202895-001	7700645*PED	2027-06-26	Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202895-001	8518987	2024-02-16	Drug substance, Drug product	2013-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202895-001	8518987*PED	2024-08-16	Pediatric extension		`1e350fbaab3a…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
814301f9-c990-46a5-b481-2879a521a16f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
81157882-d7f5-4b49-9a52-b2a0c7e54020	Product name	2	20260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2f	Product name	6	20251113
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7	Product name	1	20180911
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-565-01	ML - Milliliter	59676-565	15769aea-9842-410a-a134-27cc1a322d8d	1	2013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

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): 202895 application number: NDA202895 ndc (product): 59676-565

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33O78XF0BW	DARUNAVIR ETHANOLATE	635728-49-3	DARUNAVIR ETHANOLATE
YO603Y8113	DARUNAVIR	206361-99-1	darunavir

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1236628	darunavir 100 MG in 1 mL Oral Suspension	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
850455	darunavir 150 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir 600 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
831868	darunavir 75 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir 800 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	PREZISTA 100 MG in 1 mL Oral Suspension	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
850457	PREZISTA 150 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
794610	PREZISTA 600 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
831870	PREZISTA 75 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	Prezista 800 MG Oral Tablet	PSN	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	darunavir 100 MG/ML Oral Suspension [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
850457	darunavir 150 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
794610	darunavir 600 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
831870	darunavir 75 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	darunavir 800 MG Oral Tablet [Prezista]	SBD	814301f9-c990-46a5-b481-2879a521a16f	58
1236628	darunavir 100 MG/ML Oral Suspension	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
850455	darunavir 150 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir 600 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
831868	darunavir 75 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir 800 MG Oral Tablet	SCD	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir (as darunavir ethanolate) 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1359269	darunavir (as darunavir ethanolate) 800 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
670026	darunavir (as darunavir hydrate) 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236628	darunavir 100 MG per 1 ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	Prezista 100 MG per 1 ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1236632	Prezista 100 MG/ML Oral Suspension	SY	814301f9-c990-46a5-b481-2879a521a16f	58
850457	Prezista 150 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
794610	Prezista 600 MG (as darunavir ethanolate ) Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
794610	Prezista 600 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
831870	Prezista 75 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58
1359271	Prezista 800 MG Oral Tablet	SY	814301f9-c990-46a5-b481-2879a521a16f	58

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREZISTA	Janssen Products LP \| Janssen Pharmaceuticals, Inc \| Janssen Pharmaceutica NV \| Cilag AG \| Porton Pharma Solutions Ltd \| Janssen Cilag SpA \| JANSSEN ORTHO LLC \| Janssen Pharmaceutical Sciences Unlimited Company \| Thermo Fisher Scientific Cork Limited	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	58