Home NDC 53808-0801 Emtriva
Product NDC 53808-0801
11-digit product format 538080801
Labeler code 53808
Product ID 53808-0801_cbe7f06f-5d03-478a-b878-e9149a9cc853
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name emtricitabine
Dosage form CAPSULE
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application NDA021500
Marketing category NDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance EMTRICITABINE
Active strength 200 mg/1
Pharmacologic classes Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0801-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0801-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…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 53808-0801-1 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 53808-0801-1 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 53808-0801-1 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 53808-0801-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0801-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0801-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0801-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0801-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0801-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0801-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0801-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0801-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0801-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0801-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0801-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0801-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0801-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0801-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0801-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0801-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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…
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 53808-0801-1 Emtriva 30 in 1 BLISTER PACK CAPSULE 30 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0801 EMTRIVA (EMTRICITABINE) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20100805_d99086c9-41a4-4c69-b41a-80054e828095.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): 021500 application number: NDA021500
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0801-1 53808080101 30 in 1 BLISTER PACK Historical