TRUVADA

Product NDC
61919-669
11-digit product format
619190669
Labeler code
61919
Product ID
61919-669_9cad6d5a-7951-9080-e053-2a95a90a9281
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
NDA021752
Marketing category
NDA
Marketing start
2017-02-22
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-669-022023-07-18C16284748780-1f386c649-e860-0266-e053-dadaa90a7c1a49253228-5aaa-6ddc-e054-00144ff8d46c
61919-669-022023-01-30C16284748780-1f386c649-e860-0266-e053-dadaa90a7c1a49253228-5aaa-6ddc-e054-00144ff8d46c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-669-02EA - Each61919-669c14c10e0-be48-4ff6-9a77-14f64a1ecd1b12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-669-02619190669022 TABLET, FILM COATED in 1 BOTTLE (61919-669-02) 2017-02-220000-00-00NoNoCurrent