rukobia

Generic: fostemsavir tromethamine

Labeler: viiv healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rukobia
Generic Name fostemsavir tromethamine
Labeler viiv healthcare company
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fostemsavir tromethamine 600 mg/1

Manufacturer
ViiV Healthcare Company

Identifiers & Regulatory

Product NDC 49702-250
Product ID 49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212950
Listing Expiration 2026-12-31
Marketing Start 2020-07-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49702250
Hyphenated Format 49702-250

Supplemental Identifiers

RxCUI
2380549 2380551
UNII
2X513P36U0

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 rukobia (source: ndc)
Generic Name fostemsavir tromethamine (source: ndc)
Application Number NDA212950 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

49702-250-18 1 BOTTLE in 1 CARTON (49702-250-18) / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

fostemsavir tromethamine (600 mg/1)

Linked Drug Pages (1)

Rukobia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9a0bc98a-3305-43f1-85bf-fb1e9ba88d45", "openfda": {"unii": ["2X513P36U0"], "rxcui": ["2380549", "2380551"], "spl_set_id": ["a21006b7-6d6f-4f06-81b4-17978756452b"], "manufacturer_name": ["ViiV Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49702-250-18)  / 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "49702-250-18", "marketing_start_date": "20200702"}], "brand_name": "Rukobia", "product_id": "49702-250_9a0bc98a-3305-43f1-85bf-fb1e9ba88d45", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "49702-250", "generic_name": "fostemsavir tromethamine", "labeler_name": "ViiV Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rukobia", "active_ingredients": [{"name": "FOSTEMSAVIR TROMETHAMINE", "strength": "600 mg/1"}], "application_number": "NDA212950", "marketing_category": "NDA", "marketing_start_date": "20200702", "listing_expiration_date": "20261231"}