emtricitabine

Product NDC
69097-642
11-digit product format
690970642
Labeler code
69097
Product ID
69097-642_ac668220-d696-48b3-86f7-05509ba90805
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA091168
Marketing category
ANDA
Marketing start
2020-08-31
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
69097-642-02emtricitabine30 in 1 BOTTLECAPSULE305
69097-642-15emtricitabine1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-642-02EA - Each69097-642b1111a8b-bf82-4fd8-ba7f-2225ffd7dc9312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-642EMTRICITABINE CAPSULE [CIPLA USA INC.]4Current NDC, Legacy NDC, 2 package rows20231122_a229c922-58eb-4795-9219-6cebb1779e35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403875emtricitabine 200 MG Oral CapsulePSNa229c922-58eb-4795-9219-6cebb1779e355
403875emtricitabine 200 MG Oral CapsuleSCDa229c922-58eb-4795-9219-6cebb1779e355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-642-026909706420230 CAPSULE in 1 BOTTLE (69097-642-02) 30 capsule2020-08-310000-00-00NoNoCurrent
69097-642-15690970642151000 CAPSULE in 1 BOTTLE (69097-642-15) 1000 capsule2020-08-310000-00-00NoNoCurrent