FDA.reportPublic FDA data

Emtriva

Product NDC
53808-0801
11-digit product format
538080801
Labeler code
53808
Product ID
53808-0801_cbe7f06f-5d03-478a-b878-e9149a9cc853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021500
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
EMTRICITABINE
Active strength
200 mg/1
Pharmacologic classes
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
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
dc21b1c2-b0f7-7f56-b95f-dcd93cbc30a4Product name320240320
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0801-12020-01-31C16284748780-19d75b9cf-d913-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EMTRIVA safely and effectively. See full prescribing information for EMTRIVA. EMTRIVA (emtricitabine) capsule for oral use EMTRIVA (emtricitabine) solution for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0801-1Emtriva30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
emtricitabineACTIVE MOIETYG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0801EMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100805_d99086c9-41a4-4c69-b41a-80054e828095.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403875emtricitabine 200 MG Oral CapsulePSNd99086c9-41a4-4c69-b41a-80054e8280951
404587Emtriva 200 MG Oral CapsulePSNd99086c9-41a4-4c69-b41a-80054e8280951
404587emtricitabine 200 MG Oral Capsule [Emtriva]SBDd99086c9-41a4-4c69-b41a-80054e8280951
403875emtricitabine 200 MG Oral CapsuleSCDd99086c9-41a4-4c69-b41a-80054e8280951
404587Emtriva 200 MG Oral CapsuleSYd99086c9-41a4-4c69-b41a-80054e8280951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0801-15380808010130 in 1 BLISTER PACKHistorical