Maraviroc

Product NDC
68554-3080
11-digit product format
685543080
Labeler code
68554
Product ID
68554-3080_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
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
68554-3080-0Maraviroc60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68554-3080MARAVIROC (MARAVIROC) TABLET, FILM COATED [HETERO LABS LIMITED]1Current NDC, 1 package rows20240705_9db91945-127e-4bb6-970a-ff1e36dde658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728223maraviroc 150 MG Oral TabletPSN9db91945-127e-4bb6-970a-ff1e36dde6581
728225maraviroc 300 MG Oral TabletPSN9db91945-127e-4bb6-970a-ff1e36dde6581
728223maraviroc 150 MG Oral TabletSCD9db91945-127e-4bb6-970a-ff1e36dde6581
728225maraviroc 300 MG Oral TabletSCD9db91945-127e-4bb6-970a-ff1e36dde6581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68554-3080-06855430800060 TABLET, FILM COATED in 1 BOTTLE (68554-3080-0) 2022-02-06NoNoHistorical