FDA.reportPublic FDA data

REYATAZ

Product NDC
69189-3631
11-digit product format
691893631
Labeler code
69189
Product ID
69189-3631_48d06234-3489-471f-92b6-051f67e0a3c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATAZANAVIR
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA021567
Marketing category
NDA
Marketing start
2015-08-03
Marketing end
0000-00-00
Substance
ATAZANAVIR SULFATE
Active strength
200 mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7bc938bd-f454-36ec-72ed-9ef05424b276Product name820221117
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-3631-12020-01-31C16284748780-19d75b9cf-d3b5-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for REYATAZ. REYATAZ ® (atazanavir) capsules, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-3631-1REYATAZ1 in 1 DOSE PACKCAPSULE, GELATIN COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-3631REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170412_b5ecaee0-cf03-42ff-bb56-76dbb39b7e23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402247atazanavir sulfate 200 MG Oral CapsulePSNb5ecaee0-cf03-42ff-bb56-76dbb39b7e231
402093Reyataz 200 MG Oral CapsulePSNb5ecaee0-cf03-42ff-bb56-76dbb39b7e231
402093atazanavir 200 MG Oral Capsule [Reyataz]SBDb5ecaee0-cf03-42ff-bb56-76dbb39b7e231
402247atazanavir 200 MG Oral CapsuleSCDb5ecaee0-cf03-42ff-bb56-76dbb39b7e231
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSYb5ecaee0-cf03-42ff-bb56-76dbb39b7e231
402093Reyataz 200 MG Oral CapsuleSYb5ecaee0-cf03-42ff-bb56-76dbb39b7e231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-3631-1691893631011 in 1 DOSE PACKHistorical