Home NDC 50090-8005 Maraviroc
Product NDC 50090-8005
11-digit product format 500908005
Labeler code 50090
Product ID 50090-8005_b132ca6a-1bcb-4662-82dd-4377a1df819f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Maraviroc
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA203347
Marketing category ANDA
Marketing start 2022-02-06
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 2027-12-31
Current FDA listing Yes 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 A203347-001 MARAVIROC MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 A203347-002 MARAVIROC MARAVIROC 300MG TABLET / ORAL AB 2022-02-07
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 2 · 68 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 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Maraviroc
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MARAVIROC 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MD6P741W8A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 728225 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-8005-0 50090800500 60 TABLET, FILM COATED in 1 BOTTLE (50090-8005-0) 2026-06-25 No No Current