maraviroc

Generic: maraviroc

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name maraviroc
Generic Name maraviroc
Labeler navinta llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

maraviroc 300 mg/1

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-007
Product ID 68475-007_9623d31f-0856-4aca-a288-c542b28edfba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217880
Listing Expiration 2026-12-31
Marketing Start 2025-06-23

Pharmacologic Class

Established (EPC)
ccr5 co-receptor antagonist [epc]
Mechanism of Action
chemokine co-receptor 5 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475007
Hyphenated Format 68475-007

Supplemental Identifiers

RxCUI
728223 728225
UPC
0368475007017 0368475008014
UNII
MD6P741W8A
NUI
N0000175572 N0000175445

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name maraviroc (source: ndc)
Generic Name maraviroc (source: ndc)
Application Number ANDA217880 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68475-007-01)
source: ndc

Packages (1)

68475-007-01 60 TABLET, FILM COATED in 1 BOTTLE (68475-007-01)

Ingredients (1)

maraviroc (300 mg/1)

Linked Drug Pages (1)

Maraviroc ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9623d31f-0856-4aca-a288-c542b28edfba", "openfda": {"nui": ["N0000175572", "N0000175445"], "upc": ["0368475007017", "0368475008014"], "unii": ["MD6P741W8A"], "rxcui": ["728223", "728225"], "spl_set_id": ["211290a4-5e26-4784-aa99-8ccaf2eaaa15"], "pharm_class_epc": ["CCR5 Co-receptor Antagonist [EPC]"], "pharm_class_moa": ["Chemokine Co-receptor 5 Antagonists [MoA]"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68475-007-01)", "package_ndc": "68475-007-01", "marketing_start_date": "20250623"}], "brand_name": "Maraviroc", "product_id": "68475-007_9623d31f-0856-4aca-a288-c542b28edfba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["CCR5 Co-receptor Antagonist [EPC]", "Chemokine Co-receptor 5 Antagonists [MoA]"], "product_ndc": "68475-007", "generic_name": "Maraviroc", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Maraviroc", "active_ingredients": [{"name": "MARAVIROC", "strength": "300 mg/1"}], "application_number": "ANDA217880", "marketing_category": "ANDA", "marketing_start_date": "20250623", "listing_expiration_date": "20261231"}