Emtriva

Product NDC
61958-0601
11-digit product format
619580601
Labeler code
61958
Product ID
61958-0601_5fa131e8-fb3b-f4ac-e063-6294a90a2136
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EMTRICITABINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA021500
Marketing category
NDA
Marketing start
2003-07-02
Marketing end
2028-05-31
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
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61958-0601-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61958-0601-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61958-0601-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61958-0601-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61958-0601-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61958-0601-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61958-0601-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021500-001EMTRIVAEMTRICITABINE200MGCAPSULE / ORALABRLD, RS2003-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021500-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02c2088c7a36db…
2026-09-14 22:38:342026-08N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0284e616aacf4f…
2026-08-18 06:07:402026-07N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021500-001EMTRIVA200MGCAPSULE / ORALABRLD, RS2003-07-023a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021500-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N021500-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N021500-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021500-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021500-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021500-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021500-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021500-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021500-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021500-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021500-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021500-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021500-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021500-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021500-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021500-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021500-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021500-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021500-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021500-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021500-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021500-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021500-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021500-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021500-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021500-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021500-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021500-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021500-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021500-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021500-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021500-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021500-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021500-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021500-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021500-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021500-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021500-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021500-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021500-001AB13a93d1ddd44b…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021500-00166422452020-11-04U-54174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021500-00166422452020-11-04U-25774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021500-00167033962021-03-09Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021500-0016642245*PED2021-05-04Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021500-0016703396*PED2021-09-09Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021500-00167033962021-03-09Drug substance, Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021500-0016642245*PED2021-05-04Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021500-0016703396*PED2021-09-09Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021500-00167033962021-03-09Drug substance, Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021500-0016642245*PED2021-05-04Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021500-0016703396*PED2021-09-09Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021500-00167033962021-03-09Drug substance, Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021500-0016642245*PED2021-05-04Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021500-0016703396*PED2021-09-09Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021500-00166422452020-11-04U-2578869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021500-00166422452020-11-04U-5418869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021500-00167033962021-03-09Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021500-0016642245*PED2021-05-04Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021500-0016703396*PED2021-09-09Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021500-00166422452020-11-04U-257c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021500-00166422452020-11-04U-541c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021500-00167033962021-03-09Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021500-0016642245*PED2021-05-04Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021500-0016703396*PED2021-09-09Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021500-00166422452020-11-04U-5413f01610625f2…
2019-12-14 00:12 UTC2019-12N021500-00166422452020-11-04U-2573f01610625f2…
2019-12-14 00:12 UTC2019-12N021500-00167033962021-03-09Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021500-0016642245*PED2021-05-04Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021500-0016703396*PED2021-09-09Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021500-00166422452020-11-04U-541b00525d2431f…
2019-09-15 20:21 UTC2019-09N021500-00166422452020-11-04U-257b00525d2431f…
2019-09-15 20:21 UTC2019-09N021500-00167033962021-03-09Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021500-0016642245*PED2021-05-04Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021500-0016703396*PED2021-09-09Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021500-00166422452020-11-04U-257ea99ee380514…
2019-07-19 19:46 UTC2019-07N021500-00166422452020-11-04U-541ea99ee380514…
2019-07-19 19:46 UTC2019-07N021500-00167033962021-03-09Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021500-0016642245*PED2021-05-04Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021500-0016703396*PED2021-09-09Pediatric extensionea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Emtriva

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EMTRICITABINE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G70B4ETF4SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6599395-3944-44f9-97f2-e0424c6b6a1fAvailable on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2025-04-25These 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
2025-04-25These 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
2025-04-25These 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
2025-01-30These 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
2025-01-30These 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
2025-01-30These 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
2020-07-22These 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
2020-07-22These 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
2020-07-22These 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
61958-0601-1Emtriva30 in 1 BOTTLE, PLASTICCAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0601-1EA - Each61958-0601800c278e-db7f-4fe7-9976-a78dfda7dbed12012-07-24

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
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
emtricitabineACTIVE INGREDIENTG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
emtricitabineACTIVE MOIETYG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
emtricitabineACTIVE MOIETYG70B4ETF4SEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
crospovidoneINACTIVE INGREDIENT68401960MKEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30EMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPEMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0REMTRIVA (EMTRICITABINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0601EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.]12Current NDC, Legacy NDC, 1 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
403875emtricitabine 200 MG Oral CapsulePSNd99086c9-41a4-4c69-b41a-80054e8280951
403875emtricitabine 200 MG Oral CapsulePSN39ae3070-9b9b-41f3-b058-2e240b4ac18e1
404587Emtriva 200 MG Oral CapsulePSNd99086c9-41a4-4c69-b41a-80054e8280951
404587Emtriva 200 MG Oral CapsulePSN39ae3070-9b9b-41f3-b058-2e240b4ac18e1
404587emtricitabine 200 MG Oral Capsule [Emtriva]SBDd99086c9-41a4-4c69-b41a-80054e8280951
404587emtricitabine 200 MG Oral Capsule [Emtriva]SBD39ae3070-9b9b-41f3-b058-2e240b4ac18e1
403875emtricitabine 200 MG Oral CapsuleSCD39ae3070-9b9b-41f3-b058-2e240b4ac18e1
403875emtricitabine 200 MG Oral CapsuleSCDd99086c9-41a4-4c69-b41a-80054e8280951
404587Emtriva 200 MG Oral CapsuleSY39ae3070-9b9b-41f3-b058-2e240b4ac18e1
404587Emtriva 200 MG Oral CapsuleSYd99086c9-41a4-4c69-b41a-80054e8280951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-0601-16195806010130 CAPSULE in 1 BOTTLE, PLASTIC (61958-0601-1) 30 capsule2003-07-022028-05-31NoNoCurrent