FDA.reportPublic FDA data

Emtricitabine

Product NDC
65862-301
11-digit product format
658620301
Labeler code
65862
Product ID
65862-301_b4553ee9-214c-43d5-b704-16f4eee5f2b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079188
Marketing category
ANDA
Marketing start
2023-03-15
Substance
EMTRICITABINE
Active strength
200 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG70B4ETF4S
Rxcui403875

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-301-05Emtricitabine500 in 1 BOTTLECAPSULE5002
65862-301-30Emtricitabine30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-301-30EA - Each65862-3010419de9d-c826-4683-b98e-4f66aa4a259712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-301EMTRICITABINE CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20240209_cdfb7868-3eba-46e1-a286-ca40760fd98d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403875emtricitabine 200 MG Oral CapsulePSNcdfb7868-3eba-46e1-a286-ca40760fd98d2
403875emtricitabine 200 MG Oral CapsuleSCDcdfb7868-3eba-46e1-a286-ca40760fd98d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-301-0565862030105500 CAPSULE in 1 BOTTLE (65862-301-05) 500 capsule2023-03-15NoNoCurrent
65862-301-26658620301262500 CAPSULE in 1 BAG (65862-301-26)2500 capsule15-MAR-23Current
65862-301-306586203013030 CAPSULE in 1 BOTTLE (65862-301-30) 30 capsule2023-03-15NoNoCurrent