FDA.reportPublic FDA data

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product NDC
76282-677
11-digit product format
762820677
Labeler code
76282
Product ID
76282-677_09bb7f3f-5d80-4f4b-b681-4878830cd971
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA090958
Marketing category
ANDA
Marketing start
2021-04-06
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200; 300 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE200 mg/1
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG70B4ETF4S, OTT9J7900I
Rxcui476556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
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
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-677-30EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-677EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20210408_31af598d-6ef2-469b-ac4c-3ac805e6fa44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletPSN31af598d-6ef2-469b-ac4c-3ac805e6fa442
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral TabletSCD31af598d-6ef2-469b-ac4c-3ac805e6fa442
476556emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY31af598d-6ef2-469b-ac4c-3ac805e6fa442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-677-307628206773030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76282-677-30) 2021-04-060000-00-00NoNoCurrent