Home NDC 50090-1486 SELZENTRY
Product NDC 50090-1486
11-digit product format 500901486
Labeler code 50090
Product ID 50090-1486_074b036c-dfce-4827-9586-2d67f95891b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name maraviroc
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application NDA022128
Marketing category NDA
Marketing start 2011-05-16
Marketing end 0000-00-00
Substance MARAVIROC
Active strength 300 mg/1
Pharmacologic classes CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1486-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1486-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1486-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1486-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1486-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1486-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1486-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1486-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1486-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1486-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-1486-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-1486-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 164 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 2026-02-19 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022128-003 SELZENTRY 25MG TABLET / ORAL RLD 2016-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022128-004 SELZENTRY 75MG TABLET / ORAL RLD 2016-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022128-001 SELZENTRY 150MG TABLET / ORAL AB RLD 2007-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022128-002 SELZENTRY 300MG TABLET / ORAL AB RLD, RS 2007-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022128-003 SELZENTRY 25MG TABLET / ORAL RLD 2016-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022128-004 SELZENTRY 75MG TABLET / ORAL RLD 2016-11-04 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 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 · 2 matching rows.