FDA.reportPublic FDA data

PREZCOBIX

Product NDC
59676-575
11-digit product format
596760575
Labeler code
59676
Product ID
59676-575_9d92f536-2a35-4d1d-baca-8d87e8b8dcaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DARUNAVIR ETHANOLATE and COBICISTAT
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Products, LP
Application
NDA205395
Marketing category
NDA
Marketing start
2015-01-31
Substance
COBICISTAT; DARUNAVIR ETHANOLATE
Active strength
150; 800 mg/1; mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREZCOBIX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COBICISTAT150 mg/1
DARUNAVIR ETHANOLATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW2E03M5PG, 33O78XF0BW
Rxcui1600704, 1600710, 2710424, 2710426, 2738995, 2738999

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2fProduct name620251113
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
8abcd50f-6149-4309-942e-836623ca381dProduct name120150401
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59676-575-30PREZCOBIX30 in 1 BOTTLETABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59676-575-30EA - Each59676-575e5d18a0d-2dde-425f-8957-2e344bb114a812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COBICISTATACTIVE INGREDIENTLW2E03M5PGPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
DARUNAVIR ETHANOLATEACTIVE INGREDIENT33O78XF0BWPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
COBICISTATACTIVE MOIETYLW2E03M5PGPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
DARUNAVIRACTIVE MOIETYYO603Y8113PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59676-575PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [JANSSEN PRODUCTS LP]25Current NDC, Legacy NDC, 1 package rows20250406_9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2738995darunavir 600 MG / cobicistat 90 MG Tablet for Oral SuspensionPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710424darunavir 675 MG / cobicistat 150 MG Oral TabletPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600704darunavir 800 MG / cobicistat 150 MG Oral TabletPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710426PREZCOBIX 675 MG / 150 MG Oral TabletPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600710Prezcobix 800 MG / 150 MG Oral TabletPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2738999PREZCOBIX PED 600 MG / 90 MG Tablet for Oral SuspensionPSN9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710426cobicistat 150 MG / darunavir 675 MG Oral Tablet [Prezcobix]SBD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600710cobicistat 150 MG / darunavir 800 MG Oral Tablet [Prezcobix]SBD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2738999cobicistat 90 MG / darunavir 600 MG Tablet for Oral Suspension [Prezcobix]SBD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710424cobicistat 150 MG / darunavir 675 MG Oral TabletSCD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600704cobicistat 150 MG / darunavir 800 MG Oral TabletSCD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2738995cobicistat 90 MG / darunavir 600 MG Tablet for Oral SuspensionSCD9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2738995darunavir 600 MG (as darunavir ethanolate ) / cobicistat 90 MG Tablet for Oral SuspensionSY9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710424darunavir 675 MG (as darunavir ethanolate ) / cobicistat 150 MG Oral TabletSY9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2738999Prezcobix 600 MG (as darunavir ethanolate ) / 90 MG Tablet for Oral SuspensionSY9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
2710426Prezcobix 675 MG (as darunavir ethanolate ) / 150 MG Oral TabletSY9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600710Prezcobix 800 MG (as darunavir ethanolate ) / 150 MG Oral TabletSY9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f28
1600704darunavir 800 MG / cobicistat 150 MG Oral TabletPSN16ca460a-3c89-4697-8f45-972615a2a5189
1600710Prezcobix 800 MG / 150 MG Oral TabletPSN16ca460a-3c89-4697-8f45-972615a2a5189
1600710cobicistat 150 MG / darunavir 800 MG Oral Tablet [Prezcobix]SBD16ca460a-3c89-4697-8f45-972615a2a5189
1600704cobicistat 150 MG / darunavir 800 MG Oral TabletSCD16ca460a-3c89-4697-8f45-972615a2a5189
1600710Prezcobix 800 MG (as darunavir ethanolate ) / 150 MG Oral TabletSY16ca460a-3c89-4697-8f45-972615a2a5189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59676-575-305967605753030 TABLET, FILM COATED in 1 BOTTLE (59676-575-30) 2015-01-310000-00-00NoNoCurrent