NDC 69539-049

Abiraterone

Abiraterone Acetate

Abiraterone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Msn Laboratories Private Limited. The primary component is Abiraterone Acetate.

• Product ID: 69539-049_19fc3e14-b31a-42d4-99fb-3f554f9424e5
• NDC: 69539-049
• Product Type: Human Prescription Drug
• Proprietary Name: Abiraterone
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210686
• Labeler Name: MSN LABORATORIES PRIVATE LIMITED
• Substance Name: ABIRATERONE ACETATE
• Active Ingredient Strength: 250 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: 2022-12-31

Packaging

NDC 69539-049-92

120 TABLET in 1 BOTTLE (69539-049-92)

• Marketing Start Date: 2019-07-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69539-049-92 [69539004992]

Abiraterone TABLET

• Marketing Category: ANDA
• Application Number: ANDA210686
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-10

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	250 mg/1

OpenFDA Data

• SPL SET ID: 0a84f388-a8b4-4065-93a6-1c663c99d265
• Manufacturer:
  • MSN LABORATORIES PRIVATE LIMITED
• UNII:
  • EM5OCB9YJ6
• RxNorm Concept Unique ID - RxCUI:
  • 1100075
• UPC Code:
  • 0369539049929

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 "Abiraterone" or generic name "Abiraterone Acetate"

NDC	Brand Name	Generic Name
0143-9597	Abiraterone	Abiraterone acetate
69539-049	Abiraterone	Abiraterone
72205-030	Abiraterone	Abiraterone
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
42291-024	Abiraterone Acetate	Abiraterone
42291-073	ABIRATERONE ACETATE	ABIRATERONE
42292-057	Abiraterone Acetate	abiraterone acetate
43598-358	Abiraterone Acetate	Abiraterone Acetate
47335-401	YONSA	abiraterone acetate