NDC 47335-303

Odomzo

Sonidegib

Odomzo is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Sonidegib Phosphate.

• Product ID: 47335-303_01755c7d-439d-47d6-878a-e5b3ede4430d
• NDC: 47335-303
• Product Type: Human Prescription Drug
• Proprietary Name: Odomzo
• Generic Name: Sonidegib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-21
• Marketing Category: NDA / NDA
• Application Number: NDA205266
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: SONIDEGIB PHOSPHATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 47335-303-83

30 CAPSULE in 1 BOTTLE (47335-303-83)

• Marketing Start Date: 2017-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47335-303-83 [47335030383]

Odomzo CAPSULE

• Marketing Category: NDA
• Application Number: NDA205266
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-21

Drug Details

Active Ingredients

Ingredient	Strength
SONIDEGIB PHOSPHATE	200 mg/1

OpenFDA Data

• SPL SET ID: 028312dc-d155-4fd5-8abd-6bb9f011d3cc
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • W421AI34UW
• RxNorm Concept Unique ID - RxCUI:
  • 1659927
  • 1659921

Pharmacological Class

• Hedgehog Pathway Inhibitor [EPC]
• Smoothened Receptor Antagonists [MoA]