movantik

Generic: naloxegol oxalate

Labeler: redhill biopharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name movantik
Generic Name naloxegol oxalate
Labeler redhill biopharma ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naloxegol oxalate 25 mg/1

Manufacturer
RedHill Biopharma Ltd

Identifiers & Regulatory

Product NDC 57841-1301
Product ID 57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204760
Marketing Start 2020-10-01
Marketing End 2027-01-31

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 578411301
Hyphenated Format 57841-1301

Supplemental Identifiers

RxCUI
1551782 1551917 1551923 1601373
UPC
0357841130114 0357841130015
UNII
65I14TNM33

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 movantik (source: ndc)
Generic Name naloxegol oxalate (source: ndc)
Application Number NDA204760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)
  • 10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

57841-1301-1 30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1) 57841-1301-2 90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2) 57841-1301-3 10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK 57841-1301-4 1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

naloxegol oxalate (25 mg/1)

Linked Drug Pages (1)

MOVANTIK ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27e98e6d-9faf-3a94-e063-6394a90a1dcb", "openfda": {"upc": ["0357841130114", "0357841130015"], "unii": ["65I14TNM33"], "rxcui": ["1551782", "1551917", "1551923", "1601373"], "spl_set_id": ["300a6474-ebcd-4404-8040-48fdcfcc1635"], "manufacturer_name": ["RedHill Biopharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)", "package_ndc": "57841-1301-1", "marketing_end_date": "20270131", "marketing_start_date": "20201001"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)", "package_ndc": "57841-1301-2", "marketing_end_date": "20270131", "marketing_start_date": "20201001"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (57841-1301-3)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "57841-1301-3", "marketing_end_date": "20270131", "marketing_start_date": "20201001"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (57841-1301-4)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "57841-1301-4", "marketing_end_date": "20270131", "marketing_start_date": "20201001"}], "brand_name": "MOVANTIK", "product_id": "57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "57841-1301", "generic_name": "naloxegol oxalate", "labeler_name": "RedHill Biopharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOVANTIK", "active_ingredients": [{"name": "NALOXEGOL OXALATE", "strength": "25 mg/1"}], "application_number": "NDA204760", "marketing_category": "NDA", "marketing_end_date": "20270131", "marketing_start_date": "20201001"}