Home DailyMed 800c278e-db7f-4fe7-9976-a78dfda7dbed National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:08:15 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N021500-001 EMTRIVA 200MG CAPSULE / ORAL AB RLD, RS 2003-07-02 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.