Home DailyMed c08dae44-333e-4bfb-b0db-efe76c9580ea 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 02:36:05 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022187-001 INTELENCE ETRAVIRINE 100MG TABLET / ORAL AB RLD 2008-01-18 N022187-002 INTELENCE ETRAVIRINE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 N022187-003 INTELENCE ETRAVIRINE 25MG TABLET / ORAL RLD 2012-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 129 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 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022187-002 INTELENCE 200MG TABLET / ORAL AB RLD, RS 2010-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022187-003 INTELENCE 25MG TABLET / ORAL RLD 2012-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022187-001 INTELENCE 100MG TABLET / ORAL AB RLD 2008-01-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 207 observed states.
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 N022187-001 7887845 2019-03-25 Drug product 2011-03-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7887845*PED 2019-09-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 8003789 2019-11-01 Drug substance, Drug product 2011-09-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 6878717 2019-11-05 U-1016 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 6878717 2019-11-05 U-256 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 6878717 2019-11-05 U-2354 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 6878717 2019-11-05 U-1237 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 8003789*PED 2020-05-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 6878717*PED 2020-05-05 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7037917 2020-12-13 U-1016 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7037917 2020-12-13 U-256 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7037917 2020-12-13 U-1237 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7037917 2020-12-13 U-2354 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-001 7037917*PED 2021-06-13 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7887845 2019-03-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7887845*PED 2019-09-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 8003789 2019-11-01 Drug substance, Drug product 2011-09-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 6878717 2019-11-05 U-1016 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 6878717 2019-11-05 U-2354 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 6878717 2019-11-05 U-256 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 6878717 2019-11-05 U-1237 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 8003789*PED 2020-05-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 6878717*PED 2020-05-05 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7037917 2020-12-13 U-2354 Drug substance, Drug product 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7037917 2020-12-13 U-256 Drug substance, Drug product 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7037917 2020-12-13 U-1016 Drug substance, Drug product 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7037917 2020-12-13 U-1237 Drug substance, Drug product 2011-01-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-002 7037917*PED 2021-06-13 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 7887845 2019-03-25 Drug product 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 7887845*PED 2019-09-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 8003789 2019-11-01 Drug substance, Drug product 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 6878717 2019-11-05 U-2354 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 6878717 2019-11-05 U-256 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 6878717 2019-11-05 U-1016 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 6878717 2019-11-05 U-1237 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 8003789*PED 2020-05-01 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 6878717*PED 2020-05-05 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 7037917 2020-12-13 U-2354 Drug substance, Drug product 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 7037917 2020-12-13 U-1237 Drug substance, Drug product 2012-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022187-003 7037917*PED 2021-06-13 Pediatric extension 74a2ff9319b5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 81 observed states.
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.