FDA.reportPublic FDA data

PREZCOBIX

Product NDC
50090-1723
11-digit product format
500901723
Labeler code
50090
Product ID
50090-1723_c5bd2c9e-5b7b-4404-bcd2-a82a46da19d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DARUNAVIR ETHANOLATE and COBICISTAT
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREZCOBIX
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW2E03M5PG, 33O78XF0BW
Rxcui1600704, 1600710

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
50090-1723-0PREZCOBIX30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1723-0EA - Each50090-1723751ec0fb-c62f-489d-bde6-79fa2bf30d1712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1723PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240103_16ca460a-3c89-4697-8f45-972615a2a518.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-1723-05009017230030 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0) 2015-03-040000-00-00NoNoCurrent