FDA.reportPublic FDA data

SELZENTRY

Product NDC
49702-223
11-digit product format
497020223
Labeler code
49702
Product ID
49702-223_c3a27122-8cd6-4889-a1ef-7ef629c270b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
maraviroc
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ViiV Healthcare Company
Application
NDA022128
Marketing category
NDA
Marketing start
2011-05-16
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022128-001SELZENTRYMARAVIROC150MGTABLET / ORALABRLD2007-08-06
N022128-002SELZENTRYMARAVIROC300MGTABLET / ORALABRLD, RS2007-08-06
N022128-003SELZENTRYMARAVIROC25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-11-04
N022128-004SELZENTRYMARAVIROC75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022128-001AB
N022128-002AB

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
2026-08-01 22:54:322026-06N022128-001SELZENTRY150MGTABLET / ORALABRLD2007-08-06a50c72e98297…
2026-08-01 22:54:322026-06N022128-002SELZENTRY300MGTABLET / ORALABRLD, RS2007-08-06a50c72e98297…
2026-08-01 22:54:322026-06N022128-003SELZENTRY25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-11-04a50c72e98297…
2026-08-01 22:54:322026-06N022128-004SELZENTRY75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-11-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022128-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022128-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SELZENTRYMARAVIROCA-S Medication Solutions3c52dddd-0457-41cd-99e0-d30d4fd00ec52023-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022128
application number: NDA022128
SELZENTRYMARAVIROCViiV Healthcare Company46f30ac5-c96b-429e-976d-8c5ee1c0761b2022-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022128
application number: NDA022128
ndc (product): 49702-223

Additional Listing Data#

Finished product
Yes
Brand name base
SELZENTRY
Listing expiration
2027-12-31

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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
728223Internal RxNorm lookup
728225Internal RxNorm lookup
729201Internal RxNorm lookup
729203Internal RxNorm lookup
1857921Internal RxNorm lookup
1857925Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46f30ac5-c96b-429e-976d-8c5ee1c0761bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae2fe75-4679-c953-9914-a8340c1a78c9Product name420250516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49702-223-18SELZENTRY60 in 1 BOTTLETABLET, FILM COATED6025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49702-223-18EA - Each49702-223b29a2e57-c904-4b71-b095-b7759e9330c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MARAVIROCACTIVE INGREDIENTMD6P741W8ASELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
MARAVIROCACTIVE MOIETYMD6P741W8ASELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NSELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
TALCINACTIVE INGREDIENT7SEV7J4R1USELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSELZENTRY (MARAVIROC) TABLET, FILM COATED [VIIV HEALTHCARE COMPANY]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49702-223SELZENTRY (MARAVIROC) TABLET, FILM COATED SELZENTRY (MARAVIROC) SOLUTION SELZENTRY (MARAVIROC) KIT [VIIV HEALTHCARE COMPANY]24Current NDC, Legacy NDC, 1 package rows20240616_46f30ac5-c96b-429e-976d-8c5ee1c0761b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728223maraviroc 150 MG Oral TabletPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857921maraviroc 20 MG in 1 mL Oral SolutionPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
728225maraviroc 300 MG Oral TabletPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729201Selzentry 150 MG Oral TabletPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857925Selzentry 20 MG in 1 mL Oral SolutionPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729203Selzentry 300 MG Oral TabletPSN46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729201maraviroc 150 MG Oral Tablet [Selzentry]SBD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857925maraviroc 20 MG/ML Oral Solution [Selzentry]SBD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729203maraviroc 300 MG Oral Tablet [Selzentry]SBD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
728223maraviroc 150 MG Oral TabletSCD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857921maraviroc 20 MG/ML Oral SolutionSCD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
728225maraviroc 300 MG Oral TabletSCD46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857921maraviroc 20 MG per 1 ML Oral SolutionSY46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729201Selzentry 150 MG Oral TabletSY46f30ac5-c96b-429e-976d-8c5ee1c0761b25
1857925Selzentry 20 MG per 1 ML Oral SolutionSY46f30ac5-c96b-429e-976d-8c5ee1c0761b25
729203Selzentry 300 MG Oral TabletSY46f30ac5-c96b-429e-976d-8c5ee1c0761b25
728223maraviroc 150 MG Oral TabletPSN3c52dddd-0457-41cd-99e0-d30d4fd00ec54
729201Selzentry 150 MG Oral TabletPSN3c52dddd-0457-41cd-99e0-d30d4fd00ec54
729201maraviroc 150 MG Oral Tablet [Selzentry]SBD3c52dddd-0457-41cd-99e0-d30d4fd00ec54
728223maraviroc 150 MG Oral TabletSCD3c52dddd-0457-41cd-99e0-d30d4fd00ec54
729201Selzentry 150 MG Oral TabletSY3c52dddd-0457-41cd-99e0-d30d4fd00ec54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49702-223-184970202231860 TABLET, FILM COATED in 1 BOTTLE (49702-223-18) 2011-05-160000-00-00NoNoCurrent