Home NDC 42858-246 Maraviroc
Product NDC 42858-246
11-digit product format 428580246
Labeler code 42858
Product ID 42858-246_7f97db4c-6c65-4056-b301-53feac86d8f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Maraviroc
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rhodes Pharmaceuticals LLC
Application ANDA216143
Marketing category ANDA
Marketing start 2026-09-30
Substance MARAVIROC
Active strength 150 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 A216143-001 MARAVIROC MARAVIROC 150MG TABLET / ORAL 2025-11-04 A216143-002 MARAVIROC MARAVIROC 300MG TABLET / ORAL 2025-11-04
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.
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 A216143-001 MARAVIROC 150MG TABLET / ORAL 2025-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216143-002 MARAVIROC 300MG TABLET / ORAL 2025-11-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216143-001 MARAVIROC 150MG TABLET / ORAL 2025-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216143-002 MARAVIROC 300MG TABLET / ORAL 2025-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216143-001 MARAVIROC 150MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216143-002 MARAVIROC 300MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216143-001 MARAVIROC 150MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216143-002 MARAVIROC 300MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216143-001 MARAVIROC 150MG TABLET / ORAL 2025-11-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216143-002 MARAVIROC 300MG TABLET / ORAL 2025-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216143-001 AB 1 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216143-002 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216143-001 AB 1 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216143-002 AB 1 31067a03dcf5…
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 150 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42858-246-06 42858024606 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42858-246-06) 2026-09-30 No No Current