Home DailyMed 2afec18e-a0c8-4fc1-95a7-eaf2b3771e9b 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 01:25:01 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022145-001 ISENTRESS RALTEGRAVIR POTASSIUM EQ 400MG BASE TABLET / ORAL AB RLD, RS 2007-10-12 N022145-002 ISENTRESS HD RALTEGRAVIR POTASSIUM EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product N022145-001 7754731*PED 2029-09-11 Pediatric extension N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 N022145-002 7754731*PED 2029-09-11 Pediatric extension N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 N022145-002 9649311*PED 2031-04-21 Pediatric extension N022145-002 10772888 2032-03-30 U-1663 2020-10-27
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 3 · 86 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 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL AB RLD, RS 2007-10-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL AB RLD, RS 2017-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL AB RLD, RS 2007-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022145-001 ISENTRESS EQ 400MG BASE TABLET / ORAL RLD, RS 2007-10-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022145-002 ISENTRESS HD EQ 600MG BASE TABLET / ORAL RLD, RS 2017-05-26 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 694 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-001 7754731*PED 2029-09-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 7754731*PED 2029-09-11 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 9649311*PED 2031-04-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 7754731*PED 2029-09-11 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 9649311*PED 2031-04-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 7754731*PED 2029-09-11 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 9649311*PED 2031-04-21 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8852632 2028-01-28 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731 2029-03-11 U-257 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-001 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731 2029-03-11 U-257 Drug substance, Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 7754731*PED 2029-09-11 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 8771733 2030-06-02 U-257 Drug substance, Drug product 2023-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311 2030-10-21 Drug product 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 9649311*PED 2031-04-21 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022145-002 10772888 2032-03-30 U-1663 2020-10-27 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 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.