Home NDC 70518-1847 Emtriva
Product NDC 70518-1847
11-digit product format 705181847
Labeler code 70518
Product ID 70518-1847_da41ab3c-c728-d7ae-e053-2995a90aac7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EMTRICITABINE
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA021500
Marketing category NDA
Marketing start 2019-02-04
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-1847-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-1847-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-1847-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-1847-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-1847-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-1847-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-1847-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-1847-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-1847-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-1847-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-1847-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-1847-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021500-001 EMTRIVA EMTRICITABINE 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021500-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 N021500-001 6642245 2020-11-04 U-541 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021500-001 6642245 2020-11-04 U-257 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021500-001 6703396 2021-03-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021500-001 6642245*PED 2021-05-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021500-001 6703396*PED 2021-09-09 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021500-001 6703396 2021-03-09 Drug substance, Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021500-001 6642245*PED 2021-05-04 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021500-001 6703396*PED 2021-09-09 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021500-001 6703396 2021-03-09 Drug substance, Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021500-001 6642245*PED 2021-05-04 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021500-001 6703396*PED 2021-09-09 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021500-001 6703396 2021-03-09 Drug substance, Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021500-001 6642245*PED 2021-05-04 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021500-001 6703396*PED 2021-09-09 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021500-001 6642245 2020-11-04 U-257 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021500-001 6642245 2020-11-04 U-541 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021500-001 6703396 2021-03-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021500-001 6642245*PED 2021-05-04 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021500-001 6703396*PED 2021-09-09 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021500-001 6642245 2020-11-04 U-257 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021500-001 6642245 2020-11-04 U-541 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021500-001 6703396 2021-03-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021500-001 6642245*PED 2021-05-04 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021500-001 6703396*PED 2021-09-09 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021500-001 6642245 2020-11-04 U-541 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021500-001 6642245 2020-11-04 U-257 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021500-001 6703396 2021-03-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021500-001 6642245*PED 2021-05-04 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021500-001 6703396*PED 2021-09-09 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021500-001 6642245 2020-11-04 U-541 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021500-001 6642245 2020-11-04 U-257 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021500-001 6703396 2021-03-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021500-001 6642245*PED 2021-05-04 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021500-001 6703396*PED 2021-09-09 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021500-001 6642245 2020-11-04 U-257 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021500-001 6642245 2020-11-04 U-541 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021500-001 6703396 2021-03-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021500-001 6642245*PED 2021-05-04 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021500-001 6703396*PED 2021-09-09 Pediatric extension ea99ee380514…
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): 021500 application number: NDA021500
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-1847-0 70518184700 4 CAPSULE in 1 BLISTER PACK (70518-1847-0) 4 capsule 2019-02-04 0000-00-00 No No Current