Maraviroc

Product NDC
70710-1930
11-digit product format
707101930
Labeler code
70710
Product ID
70710-1930_b9cfbc86-86a5-487f-8b6d-1e9607d2f8f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Maraviroc
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA217880
Marketing category
ANDA
Marketing start
2025-05-23
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217880-001MARAVIROCMARAVIROC150MGTABLET / ORALAB2025-05-13
A217880-002MARAVIROCMARAVIROC300MGTABLET / ORALAB2025-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217880-001AB
A217880-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217880-001MARAVIROC150MGTABLET / ORALAB2025-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217880-002MARAVIROC300MGTABLET / ORALAB2025-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217880-001MARAVIROC150MGTABLET / ORALAB2025-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217880-002MARAVIROC300MGTABLET / ORALAB2025-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217880-001MARAVIROC150MGTABLET / ORALAB2025-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217880-002MARAVIROC300MGTABLET / ORALAB2025-05-136a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217880-001MARAVIROC150MGTABLET / ORALAB2025-05-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217880-002MARAVIROC300MGTABLET / ORALAB2025-05-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217880-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217880-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217880-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217880-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217880-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217880-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217880-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217880-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Maraviroc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARAVIROC150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MD6P741W8AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
728223Internal RxNorm lookup
728225Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bba17ba-0bc5-430c-96d1-c568e236a0edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae2fe75-4679-c953-9914-a8340c1a78c9Product name420250516
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1930-6Maraviroc60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1930-6EA - Each70710-19304a9c6ceb-416f-4940-b812-076e44548a6512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1930MARAVIROC TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 1 package rows20250523_9bba17ba-0bc5-430c-96d1-c568e236a0ed.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MaravirocMARAVIROCNavinta LLC211290a4-5e26-4784-aa99-8ccaf2eaaa152025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217880
application number: ANDA217880
MaravirocMARAVIROCZydus Pharmaceuticals USA Inc.9bba17ba-0bc5-430c-96d1-c568e236a0ed2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217880
application number: ANDA217880
ndc (product): 70710-1930

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728223maraviroc 150 MG Oral TabletPSN9bba17ba-0bc5-430c-96d1-c568e236a0ed1
728225maraviroc 300 MG Oral TabletPSN9bba17ba-0bc5-430c-96d1-c568e236a0ed1
728223maraviroc 150 MG Oral TabletSCD9bba17ba-0bc5-430c-96d1-c568e236a0ed1
728225maraviroc 300 MG Oral TabletSCD9bba17ba-0bc5-430c-96d1-c568e236a0ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1930-67071019300660 TABLET, FILM COATED in 1 BOTTLE (70710-1930-6) 2025-05-23NoNoCurrent