Home NDC 61958-0602 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61958-0602-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61958-0602-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61958-0602-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61958-0602-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61958-0602-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61958-0602-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61958-0602-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021896-001 EMTRIVA 10MG/ML SOLUTION / ORAL RLD, RS 2005-09-28 cb3db0bc1861…
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…
Additional Listing Data#
Finished product Yes
Brand name base Emtriva
Listing expiration 2026-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403875 Internal RxNorm lookup 404587 Internal RxNorm lookup 597291 Internal RxNorm lookup 616148 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Emtriva EMTRICITABINE Gilead Sciences, Inc. d6599395-3944-44f9-97f2-e0424c6b6a1f 2025-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021896 application number: NDA021896 ndc (product): 61958-0602
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 0000-00-00 No No Current