Maraviroc

Product NDC
72319-025
11-digit product format
723190025
Labeler code
72319
Product ID
72319-025_0416607a-fd74-87e3-e063-6294a90ae6b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Maraviroc
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA217114
Marketing category
ANDA
Marketing start
2023-09-15
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARAVIROC300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMD6P741W8A
Rxcui728223, 728225

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
72319-025-02Maraviroc60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-025MARAVIROC TABLET, FILM COATED [I3 PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20230915_f7b9c67b-10c6-45b5-b2a8-952cd350b0b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728223maraviroc 150 MG Oral TabletPSNf7b9c67b-10c6-45b5-b2a8-952cd350b0b13
728225maraviroc 300 MG Oral TabletPSNf7b9c67b-10c6-45b5-b2a8-952cd350b0b13
728223maraviroc 150 MG Oral TabletSCDf7b9c67b-10c6-45b5-b2a8-952cd350b0b13
728225maraviroc 300 MG Oral TabletSCDf7b9c67b-10c6-45b5-b2a8-952cd350b0b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72319-025-027231900250260 TABLET, FILM COATED in 1 BOTTLE (72319-025-02) 2023-09-15NoNoHistorical