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

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 Identifiers#

Field, Values table
Field	Values
Unii	33O78XF0BW
Rxcui	670026, 794610, 831868, 831870, 850455, 850457, 1236628, 1236632, 1359269, 1359271

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

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

PREZISTA

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#