itovebi

Generic: inavolisib

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name itovebi
Generic Name inavolisib
Labeler genentech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

inavolisib 9 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-079
Product ID 50242-079_2c0bd6f0-2999-45eb-8569-7947736710d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219249
Listing Expiration 2027-12-31
Marketing Start 2024-10-14

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
phosphoinositide 3-kinase alpha inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242079
Hyphenated Format 50242-079

Supplemental Identifiers

RxCUI
2695427 2695433 2695435 2695437
UNII
L4C1UY2NYH
NUI
N0000175605 N0000194130

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 itovebi (source: ndc)
Generic Name inavolisib (source: ndc)
Application Number NDA219249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

50242-079-08 1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE 50242-079-86 1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

inavolisib (9 mg/1)

Linked Drug Pages (1)

Itovebi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c0bd6f0-2999-45eb-8569-7947736710d3", "openfda": {"nui": ["N0000175605", "N0000194130"], "unii": ["L4C1UY2NYH"], "rxcui": ["2695427", "2695433", "2695435", "2695437"], "spl_set_id": ["5de59f5b-e5db-410f-b692-658686ef4107"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Phosphoinositide 3-Kinase alpha Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50242-079-08)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50242-079-08", "marketing_start_date": "20241014"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (50242-079-86)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50242-079-86", "marketing_start_date": "20250106"}], "brand_name": "Itovebi", "product_id": "50242-079_2c0bd6f0-2999-45eb-8569-7947736710d3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Phosphoinositide 3-Kinase alpha Inhibitors [MoA]"], "product_ndc": "50242-079", "generic_name": "Inavolisib", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Itovebi", "active_ingredients": [{"name": "INAVOLISIB", "strength": "9 mg/1"}], "application_number": "NDA219249", "marketing_category": "NDA", "marketing_start_date": "20241014", "listing_expiration_date": "20271231"}