NDC 47335-401

YONSA

Abiraterone Acetate

YONSA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Abiraterone Acetate.

• Product ID: 47335-401_017c925b-42af-4c17-971a-4cc9dbe089a1
• NDC: 47335-401
• Product Type: Human Prescription Drug
• Proprietary Name: YONSA
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA210308
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: ABIRATERONE ACETATE
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 47335-401-81

120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)

• Marketing Start Date: 2018-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47335-401-81 [47335040181]

YONSA TABLET

• Marketing Category: NDA
• Application Number: NDA210308
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-22

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	125 mg/1

OpenFDA Data

• SPL SET ID: b8967e10-f768-47ce-ac9e-2324c8390132
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • EM5OCB9YJ6
• RxNorm Concept Unique ID - RxCUI:
  • 2046579
  • 2046585

Pharmacological Class

• Cytochrome P450 17A1 Inhibitors [MoA]
• Cytochrome P450 17A1 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Cytochrome P450 17A1 Inhibitors [MoA]
• Cytochrome P450 17A1 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]

NDC Crossover Matching brand name "YONSA" or generic name "Abiraterone Acetate"

NDC	Brand Name	Generic Name
47335-401	YONSA	abiraterone acetate
0143-9597	Abiraterone	Abiraterone acetate
0093-1125	Abiraterone Acetate	Abiraterone Acetate
0378-6920	Abiraterone Acetate	abiraterone acetate
0378-6921	Abiraterone Acetate	abiraterone acetate
0378-6924	Abiraterone Acetate	abiraterone acetate
0904-6948	Abiraterone Acetate	Abiraterone Acetate
16714-963	Abiraterone Acetate	Abiraterone Acetate
42292-057	Abiraterone Acetate	abiraterone acetate
43598-358	Abiraterone Acetate	Abiraterone Acetate