NDC 61958-1701

Zydelig

Idelalisib

Zydelig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Idelalisib.

• Product ID: 61958-1701_228e809b-1bce-4d04-b13f-663424840b76
• NDC: 61958-1701
• Product Type: Human Prescription Drug
• Proprietary Name: Zydelig
• Generic Name: Idelalisib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-07-23
• Marketing Category: NDA / NDA
• Application Number: NDA205858
• Labeler Name: Gilead Sciences, Inc.
• Substance Name: IDELALISIB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61958-1701-1

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)

• Marketing Start Date: 2014-07-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61958-1701-1 [61958170101]

Zydelig TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205858
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-23

Drug Details

Active Ingredients

Ingredient	Strength
IDELALISIB	100 mg/1

OpenFDA Data

• SPL SET ID: efbdafa9-d18c-4e85-b4a2-1e620fc74e50
• Manufacturer:
  • Gilead Sciences, Inc.
• UNII:
  • YG57I8T5M0
• RxNorm Concept Unique ID - RxCUI:
  • 1544471
  • 1544473
  • 1544475
  • 1544465

Pharmacological Class

• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Kinase Inhibitor [EPC]
• Kinase Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]

NDC Crossover Matching brand name "Zydelig" or generic name "Idelalisib"

NDC	Brand Name	Generic Name
61958-1701	Zydelig	idelalisib
61958-1702	Zydelig	idelalisib