Stribild

Product NDC
69189-1201
11-digit product format
691891201
Labeler code
69189
Product ID
69189-1201_ba8255c3-a4e3-4e8d-97bd-27c4b018c553
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA203100
Marketing category
NDA
Marketing start
2015-10-28
Marketing end
0000-00-00
Substance
ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
150 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
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
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
9c956088-4d4f-4a6e-847e-6f64b96f97f1Product name120150402
8abcd50f-6149-4309-942e-836623ca381dProduct name120150401
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-1201-1Stribild1 in 1 DOSE PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-1201STRIBILD (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170412_8ac4d501-7f05-426e-93be-a42240087b0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1306292elvitegravir 150 MG / cobicistat 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN8ac4d501-7f05-426e-93be-a42240087b0c1
1306298Stribild 150 MG / 150 MG / 200 MG / 300 MG Oral TabletPSN8ac4d501-7f05-426e-93be-a42240087b0c1
1306298cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Stribild]SBD8ac4d501-7f05-426e-93be-a42240087b0c1
1306292cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD8ac4d501-7f05-426e-93be-a42240087b0c1
1306292cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY8ac4d501-7f05-426e-93be-a42240087b0c1
1306298Stribild (cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral TabletSY8ac4d501-7f05-426e-93be-a42240087b0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-1201-1691891201011 in 1 DOSE PACKHistorical