Home NDC 61958-0602-1 Emtriva
Product NDC 61958-0602
Requested package NDC 61958-0602-1
11-digit product format 619580602
Labeler code 61958
Product ID 61958-0602_5fa131e8-fb3b-f4ac-e063-6294a90a2136
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
Marketing end 2028-02-29
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
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021896-001 EMTRIVA EMTRICITABINE 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 3a93d1ddd44b…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021896-001 6642245 2020-11-04 U-257 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6703396 2021-03-09 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6642245*PED 2021-05-04 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021896-001 6703396*PED 2021-09-09 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021896-001 6703396 2021-03-09 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021896-001 6642245*PED 2021-05-04 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021896-001 6703396*PED 2021-09-09 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021896-001 6642245 2020-11-04 U-257 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021896-001 6642245 2020-11-04 U-257 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6703396 2021-03-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6642245*PED 2021-05-04 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021896-001 6703396*PED 2021-09-09 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021896-001 6642245 2020-11-04 U-257 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6703396 2021-03-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6642245*PED 2021-05-04 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021896-001 6703396*PED 2021-09-09 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021896-001 6642245 2020-11-04 U-257 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6703396 2021-03-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6642245*PED 2021-05-04 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021896-001 6703396*PED 2021-09-09 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021896-001 6642245 2020-11-04 U-257 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6703396 2021-03-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6642245*PED 2021-05-04 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021896-001 6703396*PED 2021-09-09 Pediatric extension ea99ee380514…
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 Ingredient Strength EMTRICITABINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G70B4ETF4S Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-04-25 These 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 2025-04-25 These 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 2025-04-25 These 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 2025-01-30 These 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 2025-01-30 These 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 2025-01-30 These 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 2020-07-22 These 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 2020-07-22 These 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 2020-07-22 These 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 NDC Product Description Form Quantity Strength SPL version 61958-0602-1 Emtriva 1 in 1 CARTON SOLUTION 1 13 61958-0602-1 Emtriva 170 mL in 1 BOTTLE, DISPENSING SOLUTION 170 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EMTRICITABINE ACTIVE INGREDIENT G70B4ETF4S EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 EMTRICITABINE ACTIVE MOIETY G70B4ETF4S EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-0602 EMTRIVA (EMTRICITABINE) CAPSULE EMTRIVA (EMTRICITABINE) SOLUTION [GILEAD SCIENCES, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250427_d6599395-3944-44f9-97f2-e0424c6b6a1f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61958-0602-1 61958060201 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) / 170 mL in 1 BOTTLE, DISPENSING 2005-09-28 2028-02-29 No No Current