Home NDC 68554-3079 Maraviroc
Product NDC 68554-3079
11-digit product format 685543079
Labeler code 68554
Product ID 68554-3079_1c6b1759-8500-1fec-e063-6294a90afabc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Maraviroc
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hetero Labs Limited
Application ANDA203347
Marketing category ANDA
Marketing start 2022-02-06
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 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 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 · 64 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 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…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203347-001 MARAVIROC 150MG TABLET / ORAL AB 2022-02-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A203347-002 MARAVIROC 300MG TABLET / ORAL AB 2022-02-07 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Maraviroc
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MARAVIROC 150 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 68554-3079-0 Maraviroc 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68554-3079 MARAVIROC (MARAVIROC) TABLET, FILM COATED [HETERO LABS LIMITED] 1 Current NDC, 1 package rows 20240705_9db91945-127e-4bb6-970a-ff1e36dde658.zip
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Maraviroc MARAVIROC A-S Medication Solutions 0c5f41e8-d358-403a-b199-6b9028b52748 2026-06-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203347 application number: ANDA203347 Maraviroc MARAVIROC Hetero Labs Limited 9db91945-127e-4bb6-970a-ff1e36dde658 2024-07-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203347 application number: ANDA203347 ndc (product): 68554-3079 Maraviroc MARAVIROC XLCare Pharmaceuticals Inc. d3a728e2-1866-462e-bfcc-5f3c9dd88794 2023-07-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203347 application number: ANDA203347 Maraviroc MARAVIROC Camber Pharmaceuticals, Inc. 09ec3e79-c0d3-4b8f-80d8-0a854c4ca339 2022-01-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203347 application number: ANDA203347
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68554-3079-0 68554307900 60 TABLET, FILM COATED in 1 BOTTLE (68554-3079-0) 2022-02-06 No No Current