Home DailyMed 773887c8-4e31-4550-a5d9-6a2ac476b71f 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 02:04:48 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022128-001 SELZENTRY MARAVIROC 150MG TABLET / ORAL AB RLD 2007-08-06 N022128-002 SELZENTRY MARAVIROC 300MG TABLET / ORAL AB RLD, RS 2007-08-06 N022128-003 SELZENTRY MARAVIROC 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 N022128-004 SELZENTRY MARAVIROC 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04
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 5 · 172 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 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022128-003 SELZENTRY 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022128-004 SELZENTRY 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2016-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022128-003 SELZENTRY 25MG TABLET / ORAL RLD 2016-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022128-004 SELZENTRY 75MG TABLET / ORAL RLD 2016-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022128-003 SELZENTRY 25MG TABLET / ORAL RLD 2016-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022128-004 SELZENTRY 75MG TABLET / ORAL RLD 2016-11-04 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Observed Orange Book patent history# Patent history page 1 of 8 · 316 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-001 6667314*PED 2022-02-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-001 7368460 2022-11-25 U-824 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-001 7368460*PED 2023-05-25 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-002 6667314*PED 2022-02-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-002 7368460 2022-11-25 U-824 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-002 7368460*PED 2023-05-25 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-003 6667314*PED 2022-02-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-003 7368460 2022-11-25 U-824 2016-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-003 7368460*PED 2023-05-25 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-004 6667314*PED 2022-02-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-004 7368460 2022-11-25 U-824 2016-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022128-004 7368460*PED 2023-05-25 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022128-001 6667314*PED 2022-02-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-001 7368460 2022-11-25 U-824 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-001 7368460*PED 2023-05-25 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-002 6667314*PED 2022-02-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-002 7368460 2022-11-25 U-824 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-002 7368460*PED 2023-05-25 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-003 6667314*PED 2022-02-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-003 7368460 2022-11-25 U-824 2016-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-003 7368460*PED 2023-05-25 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-004 6667314*PED 2022-02-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-004 7368460 2022-11-25 U-824 2016-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022128-004 7368460*PED 2023-05-25 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022128-001 6667314*PED 2022-02-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-001 7368460 2022-11-25 U-824 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-001 7368460*PED 2023-05-25 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-002 6667314*PED 2022-02-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-002 7368460 2022-11-25 U-824 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-002 7368460*PED 2023-05-25 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-003 6667314*PED 2022-02-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-003 7368460 2022-11-25 U-824 2016-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-003 7368460*PED 2023-05-25 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-004 6667314*PED 2022-02-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-004 7368460 2022-11-25 U-824 2016-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022128-004 7368460*PED 2023-05-25 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022128-001 6586430 2019-12-01 U-824 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022128-001 7576097 2021-05-25 Drug substance 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022128-001 6667314 2021-08-06 U-824 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022128-001 7368460 2022-11-25 U-824 74a2ff9319b5…
Observed Orange Book exclusivity history# 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.