Home NDC 68475-007 Maraviroc
Product NDC 68475-007
11-digit product format 684750007
Labeler code 68475
Product ID 68475-007_9623d31f-0856-4aca-a288-c542b28edfba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Maraviroc
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Navinta LLC
Application ANDA217880
Marketing category ANDA
Marketing start 2025-06-23
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A217880-001 MARAVIROC MARAVIROC 150MG TABLET / ORAL AB 2025-05-13 A217880-002 MARAVIROC MARAVIROC 300MG TABLET / ORAL AB 2025-05-13
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.
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 A217880-001 MARAVIROC 150MG TABLET / ORAL AB 2025-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217880-002 MARAVIROC 300MG TABLET / ORAL AB 2025-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217880-001 MARAVIROC 150MG TABLET / ORAL AB 2025-05-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217880-002 MARAVIROC 300MG TABLET / ORAL AB 2025-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217880-001 MARAVIROC 150MG TABLET / ORAL AB 2025-05-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217880-002 MARAVIROC 300MG TABLET / ORAL AB 2025-05-13 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217880-001 MARAVIROC 150MG TABLET / ORAL AB 2025-05-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217880-002 MARAVIROC 300MG TABLET / ORAL AB 2025-05-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Maraviroc
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 728223 Internal RxNorm lookup 728225 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68475-007-01 Maraviroc 60 in 1 BOTTLE TABLET, FILM COATED 60 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68475-007-01 68475000701 60 TABLET, FILM COATED in 1 BOTTLE (68475-007-01) 2025-06-23 No No Current