FDA.reportPublic FDA data

Emtriva

Product NDC
61958-0602
11-digit product format
619580602
Labeler code
61958
Product ID
61958-0602_13ed3577-67a4-4828-b886-f35206f149a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EMTRICITABINE
Dosage form
SOLUTION
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA021896
Marketing category
NDA
Marketing start
2005-09-28
Substance
EMTRICITABINE
Active strength
10 mg/mL
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
Emtriva
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG70B4ETF4S
Rxcui403875, 404587, 597291, 616148

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
61958-0602-12025-04-25C16284748780-1ab0e2407-303e-f274-e053-dbdaa90a6471These 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) oral solution Initial U.S. Approval: 2003
61958-0602-12025-01-30C16284748780-1ab0e2407-303e-f274-e053-dbdaa90a6471These 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) oral solution Initial U.S. Approval: 2003
61958-0602-12020-07-22C16284748780-1ab0e2407-303e-f274-e053-dbdaa90a6471These 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) oral solution Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0602-1Emtriva1 in 1 CARTONSOLUTION113
61958-0602-1Emtriva170 mL in 1 BOTTLE, DISPENSINGSOLUTION17013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0602-1ML - Milliliter61958-06024b28b7f7-c070-41a1-8e23-da6fa9e91a4512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
EMTRICITABINEACTIVE MOIETYG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0REMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EEMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0602EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]12Current NDC, Legacy NDC, 2 package rows20250427_d6599395-3944-44f9-97f2-e0424c6b6a1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597291emtricitabine 10 MG in 1 mL Oral SolutionPSNd6599395-3944-44f9-97f2-e0424c6b6a1f13
403875emtricitabine 200 MG Oral CapsulePSNd6599395-3944-44f9-97f2-e0424c6b6a1f13
616148Emtriva 10 MG in 1 mL Oral SolutionPSNd6599395-3944-44f9-97f2-e0424c6b6a1f13
404587Emtriva 200 MG Oral CapsulePSNd6599395-3944-44f9-97f2-e0424c6b6a1f13
616148emtricitabine 10 MG/ML Oral Solution [Emtriva]SBDd6599395-3944-44f9-97f2-e0424c6b6a1f13
404587emtricitabine 200 MG Oral Capsule [Emtriva]SBDd6599395-3944-44f9-97f2-e0424c6b6a1f13
597291emtricitabine 10 MG/ML Oral SolutionSCDd6599395-3944-44f9-97f2-e0424c6b6a1f13
403875emtricitabine 200 MG Oral CapsuleSCDd6599395-3944-44f9-97f2-e0424c6b6a1f13
597291emtricitabine 10 MG per 1 ML Oral SolutionSYd6599395-3944-44f9-97f2-e0424c6b6a1f13
616148Emtriva 10 MG per 1 ML Oral SolutionSYd6599395-3944-44f9-97f2-e0424c6b6a1f13
616148Emtriva 10 MG/ML Oral SolutionSYd6599395-3944-44f9-97f2-e0424c6b6a1f13
404587Emtriva 200 MG Oral CapsuleSYd6599395-3944-44f9-97f2-e0424c6b6a1f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61958-0602-1619580602011 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING2005-09-280000-00-00NoNoCurrent