FDA.reportPublic FDA data

PREZISTA

Product NDC
59676-562
11-digit product format
596760562
Labeler code
59676
Product ID
59676-562_3d80bc62-24ac-c092-e063-6394a90a7bba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darunavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Products LP
Application
NDA021976
Marketing category
NDA
Marketing start
2008-03-08
Substance
DARUNAVIR ETHANOLATE
Active strength
600 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
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
IngredientStrength
DARUNAVIR ETHANOLATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33O78XF0BW
Rxcui670026, 794610, 831868, 831870, 850455, 850457, 1236628, 1236632, 1359269, 1359271

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2fProduct name620251113
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-562-01PREZISTA60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6058

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-562-01EA - Each59676-562537c9b7d-e5f9-42c1-aba9-575fe59dd92212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
darunavir ethanolateACTIVE INGREDIENT33O78XF0BWPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
darunavirACTIVE MOIETYYO603Y8113PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
crospovidoneINACTIVE INGREDIENT68401960MKPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
magnesium stearateINACTIVE INGREDIENT70097M6I30PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
polyvinyl alcoholINACTIVE INGREDIENT532B59J990PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
talcINACTIVE INGREDIENT7SEV7J4R1UPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
WATERINACTIVE INGREDIENT059QF0KO0RPREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]31
DARUNAVIR ETHANOLATEACTIVE INGREDIENT33O78XF0BWPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
darunavirACTIVE MOIETYYO603Y8113PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREZISTA (DARUNAVIR ETHANOLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
darunavir ethanolateACTIVE INGREDIENT33O78XF0BWPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
darunavirACTIVE MOIETYYO603Y8113PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPREZISTA (DARUNAVIR) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-562PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]57Current NDC, Legacy NDC, 1 package rows20240724_814301f9-c990-46a5-b481-2879a521a16f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236628darunavir 100 MG in 1 mL Oral SuspensionPSN814301f9-c990-46a5-b481-2879a521a16f58
850455darunavir 150 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
670026darunavir 600 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
831868darunavir 75 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
1359269darunavir 800 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
1236632PREZISTA 100 MG in 1 mL Oral SuspensionPSN814301f9-c990-46a5-b481-2879a521a16f58
850457PREZISTA 150 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
794610PREZISTA 600 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
831870PREZISTA 75 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
1359271Prezista 800 MG Oral TabletPSN814301f9-c990-46a5-b481-2879a521a16f58
1236632darunavir 100 MG/ML Oral Suspension [Prezista]SBD814301f9-c990-46a5-b481-2879a521a16f58
850457darunavir 150 MG Oral Tablet [Prezista]SBD814301f9-c990-46a5-b481-2879a521a16f58
794610darunavir 600 MG Oral Tablet [Prezista]SBD814301f9-c990-46a5-b481-2879a521a16f58
831870darunavir 75 MG Oral Tablet [Prezista]SBD814301f9-c990-46a5-b481-2879a521a16f58
1359271darunavir 800 MG Oral Tablet [Prezista]SBD814301f9-c990-46a5-b481-2879a521a16f58
1236628darunavir 100 MG/ML Oral SuspensionSCD814301f9-c990-46a5-b481-2879a521a16f58
850455darunavir 150 MG Oral TabletSCD814301f9-c990-46a5-b481-2879a521a16f58
670026darunavir 600 MG Oral TabletSCD814301f9-c990-46a5-b481-2879a521a16f58
831868darunavir 75 MG Oral TabletSCD814301f9-c990-46a5-b481-2879a521a16f58
1359269darunavir 800 MG Oral TabletSCD814301f9-c990-46a5-b481-2879a521a16f58
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
1236628darunavir 100 MG per 1 ML Oral SuspensionSY814301f9-c990-46a5-b481-2879a521a16f58
1236632Prezista 100 MG per 1 ML Oral SuspensionSY814301f9-c990-46a5-b481-2879a521a16f58
1236632Prezista 100 MG/ML Oral SuspensionSY814301f9-c990-46a5-b481-2879a521a16f58
850457Prezista 150 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
794610Prezista 600 MG (as darunavir ethanolate ) Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
794610Prezista 600 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
831870Prezista 75 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
1359271Prezista 800 MG Oral TabletSY814301f9-c990-46a5-b481-2879a521a16f58
824338darunavir 400 MG Oral TabletPSN4cde01bb-230b-42d8-a9e1-4c7da1a01b763
670026darunavir 600 MG Oral TabletPSN4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824876PREZISTA 400 MG Oral TabletPSN4cde01bb-230b-42d8-a9e1-4c7da1a01b763
794610PREZISTA 600 MG Oral TabletPSN4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824876darunavir 400 MG Oral Tablet [Prezista]SBD4cde01bb-230b-42d8-a9e1-4c7da1a01b763
794610darunavir 600 MG Oral Tablet [Prezista]SBD4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824338darunavir 400 MG Oral TabletSCD4cde01bb-230b-42d8-a9e1-4c7da1a01b763
670026darunavir 600 MG Oral TabletSCD4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824338darunavir (as darunavir ethanolate) 400 MG Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824876Prezista 400 MG Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
794610Prezista 600 MG (as darunavir ethanolate ) Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
794610Prezista 600 MG Oral TabletSY4cde01bb-230b-42d8-a9e1-4c7da1a01b763
824338darunavir 400 MG Oral TabletPSN13671be1-b4b4-44c9-a27d-0727f937bb3c2
670026darunavir 600 MG Oral TabletPSN13671be1-b4b4-44c9-a27d-0727f937bb3c2
824876PREZISTA 400 MG Oral TabletPSN13671be1-b4b4-44c9-a27d-0727f937bb3c2
794610PREZISTA 600 MG Oral TabletPSN13671be1-b4b4-44c9-a27d-0727f937bb3c2
824876darunavir 400 MG Oral Tablet [Prezista]SBD13671be1-b4b4-44c9-a27d-0727f937bb3c2
794610darunavir 600 MG Oral Tablet [Prezista]SBD13671be1-b4b4-44c9-a27d-0727f937bb3c2
824338darunavir 400 MG Oral TabletSCD13671be1-b4b4-44c9-a27d-0727f937bb3c2
670026darunavir 600 MG Oral TabletSCD13671be1-b4b4-44c9-a27d-0727f937bb3c2
824338darunavir (as darunavir ethanolate) 400 MG Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2
824876Prezista 400 MG Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2
794610Prezista 600 MG (as darunavir ethanolate ) Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2
794610Prezista 600 MG Oral TabletSY13671be1-b4b4-44c9-a27d-0727f937bb3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59676-562-015967605620160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01) 2008-03-080000-00-00NoNoCurrent