zydelig

Generic: idelalisib

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

Drug Facts

Product Profile

Brand Name zydelig
Generic Name idelalisib
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

idelalisib 150 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1702
Product ID 61958-1702_ca3e7112-6dfe-403f-af6f-a0051e77d125
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205858
Listing Expiration 2026-12-31
Marketing Start 2014-07-23

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
kinase inhibitors [moa] cytochrome p450 3a inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619581702
Hyphenated Format 61958-1702

Supplemental Identifiers

RxCUI
1544465 1544471 1544473 1544475
UNII
YG57I8T5M0
NUI
N0000175605 N0000175082 N0000190114

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 zydelig (source: ndc)
Generic Name idelalisib (source: ndc)
Application Number NDA205858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)
source: ndc

Packages (1)

61958-1702-1 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)

Ingredients (1)

idelalisib (150 mg/1)

Linked Drug Pages (1)

Zydelig ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca3e7112-6dfe-403f-af6f-a0051e77d125", "openfda": {"nui": ["N0000175605", "N0000175082", "N0000190114"], "unii": ["YG57I8T5M0"], "rxcui": ["1544465", "1544471", "1544473", "1544475"], "spl_set_id": ["efbdafa9-d18c-4e85-b4a2-1e620fc74e50"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Kinase Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)", "package_ndc": "61958-1702-1", "marketing_start_date": "20140723"}], "brand_name": "Zydelig", "product_id": "61958-1702_ca3e7112-6dfe-403f-af6f-a0051e77d125", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "61958-1702", "generic_name": "idelalisib", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zydelig", "active_ingredients": [{"name": "IDELALISIB", "strength": "150 mg/1"}], "application_number": "NDA205858", "marketing_category": "NDA", "marketing_start_date": "20140723", "listing_expiration_date": "20261231"}