Maraviroc

Product NDC: 50090-8010
11-digit product format: 500908010
Labeler code: 50090
Product ID: 50090-8010_72fd8e22-0f78-4f79-b952-625070540a93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Maraviroc
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA217114
Marketing category: ANDA
Marketing start: 2023-09-15
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
A217114-001	MARAVIROC	MARAVIROC	150MG	TABLET / ORAL	AB		2023-08-17
A217114-002	MARAVIROC	MARAVIROC	300MG	TABLET / ORAL	AB		2023-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217114-001	AB
A217114-002	AB

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217114-001	MARAVIROC	150MG	TABLET / ORAL	AB	2023-08-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217114-002	MARAVIROC	300MG	TABLET / ORAL	AB	2023-08-17	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217114-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217114-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217114-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217114-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217114-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217114-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217114-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217114-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217114-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217114-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217114-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217114-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217114-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217114-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217114-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217114-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217114-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217114-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217114-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217114-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217114-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217114-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217114-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217114-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217114-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217114-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217114-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217114-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217114-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217114-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217114-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217114-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217114-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217114-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217114-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217114-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217114-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217114-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217114-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217114-002	AB	1	`a72a2bbeb626…`

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

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
728223	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5c4a1da5-a8e1-4038-970d-fb15c189c35e	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maraviroc	MARAVIROC	A-S Medication Solutions	5c4a1da5-a8e1-4038-970d-fb15c189c35e	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217114 application number: ANDA217114 ndc (product): 50090-8010
Maraviroc	MARAVIROC	A2A Integrated Pharmaceuticals	2a16417d-a3b8-483b-9dfe-d5263cc16538	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217114 application number: ANDA217114
Maraviroc	MARAVIROC	i3 Pharmaceuticals, LLC	f7b9c67b-10c6-45b5-b2a8-952cd350b0b1	2023-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217114 application number: ANDA217114

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MD6P741W8A	MARAVIROC	376348-65-1	MARAVIROC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-8010-0	50090801000	60 TABLET, FILM COATED in 1 BOTTLE (50090-8010-0)	2026-07-08	No	No	Current