maraviroc

Generic: maraviroc

Labeler: hetero labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name maraviroc
Generic Name maraviroc
Labeler hetero labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

maraviroc 300 mg/1

Manufacturer
Hetero Labs Limited

Identifiers & Regulatory

Product NDC 68554-3080
Product ID 68554-3080_1c6b1759-8500-1fec-e063-6294a90afabc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203347
Listing Expiration 2026-12-31
Marketing Start 2022-02-06

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 685543080
Hyphenated Format 68554-3080

Supplemental Identifiers

RxCUI
728223 728225
UPC
0368554307908 0368554308004
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 ANDA203347 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (68554-3080-0)
source: ndc

Packages (1)

68554-3080-0 60 TABLET, FILM COATED in 1 BOTTLE (68554-3080-0)

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": "1c6b1759-8500-1fec-e063-6294a90afabc", "openfda": {"nui": ["N0000175572", "N0000175445"], "upc": ["0368554307908", "0368554308004"], "unii": ["MD6P741W8A"], "rxcui": ["728223", "728225"], "spl_set_id": ["9db91945-127e-4bb6-970a-ff1e36dde658"], "pharm_class_epc": ["CCR5 Co-receptor Antagonist [EPC]"], "pharm_class_moa": ["Chemokine Co-receptor 5 Antagonists [MoA]"], "manufacturer_name": ["Hetero Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68554-3080-0)", "package_ndc": "68554-3080-0", "marketing_start_date": "20220206"}], "brand_name": "Maraviroc", "product_id": "68554-3080_1c6b1759-8500-1fec-e063-6294a90afabc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["CCR5 Co-receptor Antagonist [EPC]", "Chemokine Co-receptor 5 Antagonists [MoA]"], "product_ndc": "68554-3080", "generic_name": "Maraviroc", "labeler_name": "Hetero Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Maraviroc", "active_ingredients": [{"name": "MARAVIROC", "strength": "300 mg/1"}], "application_number": "ANDA203347", "marketing_category": "ANDA", "marketing_start_date": "20220206", "listing_expiration_date": "20261231"}