FDA.reportPublic FDA data

PREZCOBIX PED

Product NDC
59676-577
11-digit product format
596760577
Labeler code
59676
Product ID
59676-577_37a1f6a0-296b-47ee-8060-9e89b01eae72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DARUNAVIR ETHANOLATE and COBICISTAT
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Labeler
Janssen Products, LP
Application
NDA220092
Marketing category
NDA
Marketing start
2026-02-27
Substance
DARUNAVIR ETHANOLATE; COBICISTAT
Active strength
600; 90 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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220092-001PREZCOBIX PEDCOBICISTAT; DARUNAVIR ETHANOLATE90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220092-001PREZCOBIX PED90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-2784e616aacf4f…
2026-08-18 06:07:402026-07N220092-001PREZCOBIX PED90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220092-001PREZCOBIX PED90MG;EQ 600MG BASETABLET, FOR SUSPENSION / ORALRLD, RS2026-02-27a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARUNAVIR ETHANOLATE600 mg/1
COBICISTAT90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LW2E03M5PGInternal UNII lookup
33O78XF0BWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1600704Internal RxNorm lookup
1600710Internal RxNorm lookup
2710424Internal RxNorm lookup
2710426Internal RxNorm lookup
2738995Internal RxNorm lookup
2738999Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2fProduct name620251113
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
59676-577-30PREZCOBIX PED30 in 1 BOTTLETABLET, FOR SUSPENSION3028

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREZCOBIXDARUNAVIR ETHANOLATE AND COBICISTATJanssen Products, LP9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f2026-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 220092
application number: NDA220092
ndc (product): 59676-577

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59676-577-305967605773030 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30) 2026-02-27NoNoCurrent