movantik

Generic: naloxegol oxalate

Labeler: valinor pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name movantik
Generic Name naloxegol oxalate
Labeler valinor pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naloxegol oxalate 12.5 mg/1

Manufacturer
Valinor Pharma, LLC

Identifiers & Regulatory

Product NDC 82625-8801
Product ID 82625-8801_6747ab38-787e-4cd4-9626-b79b0432bc36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204760
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 826258801
Hyphenated Format 82625-8801

Supplemental Identifiers

RxCUI
1551782 1551917 1551923 1601373
UPC
0382625880213 0382625880114
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
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82625-8801-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82625-8801-2)
  • 10 BLISTER PACK in 1 CARTON (82625-8801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (82625-8801-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

82625-8801-1 30 TABLET, FILM COATED in 1 BOTTLE (82625-8801-1) 82625-8801-2 90 TABLET, FILM COATED in 1 BOTTLE (82625-8801-2) 82625-8801-3 10 BLISTER PACK in 1 CARTON (82625-8801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK 82625-8801-4 1 BLISTER PACK in 1 CARTON (82625-8801-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

naloxegol oxalate (12.5 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": "6747ab38-787e-4cd4-9626-b79b0432bc36", "openfda": {"upc": ["0382625880213", "0382625880114"], "unii": ["65I14TNM33"], "rxcui": ["1551782", "1551917", "1551923", "1601373"], "spl_set_id": ["28596788-b73f-4247-85fc-3105f51fff5a"], "manufacturer_name": ["Valinor Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82625-8801-1)", "package_ndc": "82625-8801-1", "marketing_start_date": "20230328"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82625-8801-2)", "package_ndc": "82625-8801-2", "marketing_start_date": "20230328"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (82625-8801-3)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "82625-8801-3", "marketing_start_date": "20230328"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (82625-8801-4)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "82625-8801-4", "marketing_start_date": "20230328"}], "brand_name": "MOVANTIK", "product_id": "82625-8801_6747ab38-787e-4cd4-9626-b79b0432bc36", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "82625-8801", "generic_name": "naloxegol oxalate", "labeler_name": "Valinor Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MOVANTIK", "active_ingredients": [{"name": "NALOXEGOL OXALATE", "strength": "12.5 mg/1"}], "application_number": "NDA204760", "marketing_category": "NDA", "marketing_start_date": "20230328", "listing_expiration_date": "20261231"}