FDA.reportPublic FDA data

EVOTAZ

Product NDC
0003-3641
11-digit product format
000033641
Labeler code
0003
Product ID
0003-3641_fa642c67-5a9e-4136-a141-64e1236f6a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atazanavir and cobicistat
Dosage form
TABLET
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA206353
Marketing category
NDA
Marketing start
2015-01-29
Substance
ATAZANAVIR SULFATE; COBICISTAT
Active strength
300; 150 mg/1; mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 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], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATAZANAVIR SULFATE300 mg/1
COBICISTAT150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4MT4VIE29P, LW2E03M5PG
Rxcui1601654, 1601660

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
7bc938bd-f454-36ec-72ed-9ef05424b276Product name820221117
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
0003-3641-11EVOTAZ30 in 1 BOTTLETABLET3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-3641-11EA - Each0003-3641ac733342-64b3-4f0b-a025-97e05e26455c12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATAZANAVIR SULFATEACTIVE INGREDIENT4MT4VIE29PEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
COBICISTATACTIVE INGREDIENTLW2E03M5PGEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
ATAZANAVIRACTIVE MOIETYQZU4H47A3SEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
COBICISTATACTIVE MOIETYLW2E03M5PGEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0003-3641EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.]16Current NDC, Legacy NDC, 1 package rows20250524_83db29d7-5d85-49d6-8cb6-740473365cf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601654atazanavir 300 MG / cobicistat 150 MG Oral TabletPSN83db29d7-5d85-49d6-8cb6-740473365cf816
1601660EVOTAZ 300 MG / 150 MG Oral TabletPSN83db29d7-5d85-49d6-8cb6-740473365cf816
1601660atazanavir 300 MG / cobicistat 150 MG Oral Tablet [Evotaz]SBD83db29d7-5d85-49d6-8cb6-740473365cf816
1601654atazanavir 300 MG / cobicistat 150 MG Oral TabletSCD83db29d7-5d85-49d6-8cb6-740473365cf816
1601660Evotaz (atazanavir 300 MG (as atazanavir sulfate 342 MG) / cobicistat 150 MG) Oral TabletSY83db29d7-5d85-49d6-8cb6-740473365cf816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0003-3641-110000336411130 TABLET in 1 BOTTLE (0003-3641-11) 30 tablet2015-01-290000-00-00NoNoCurrent