NDC 60505-4327

Abiraterone Acetate

Abiraterone Acetate

Abiraterone Acetate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Abiraterone Acetate.

• Product ID: 60505-4327_249bb36e-0c42-5bce-e326-869606ac4999
• NDC: 60505-4327
• Product Type: Human Prescription Drug
• Proprietary Name: Abiraterone Acetate
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208453
• Labeler Name: Apotex Corp.
• 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 60505-4327-1

120 TABLET in 1 BOTTLE (60505-4327-1)

• Marketing Start Date: 2018-11-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60505-4327-1 [60505432701]

Abiraterone Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA208453
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-23

NDC 60505-4327-3 [60505432703]

Abiraterone Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA208453
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-11-23

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	250 mg/1

OpenFDA Data

• SPL SET ID: 2ac063f0-4177-c90f-27c3-e70e29689255
• Manufacturer:
  • Apotex Corp.
• UNII:
  • EM5OCB9YJ6
• RxNorm Concept Unique ID - RxCUI:
  • 1100075

Pharmacological Class

• 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 Acetate" or generic name "Abiraterone Acetate"

NDC	Brand Name	Generic Name
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
69238-1165	Abiraterone Acetate	Abiraterone Acetate
51407-181	Abiraterone Acetate	Abiraterone Acetate
57894-199	Abiraterone acetate	Abiraterone acetate
57894-155	Abiraterone acetate	Abiraterone acetate
60505-4327	Abiraterone Acetate	Abiraterone Acetate
64679-021	Abiraterone acetate	Abiraterone acetate
64980-418	Abiraterone acetate	Abiraterone acetate
60687-455	Abiraterone Acetate	Abiraterone Acetate
72606-566	Abiraterone acetate	Abiraterone acetate
68462-135	abiraterone acetate	abiraterone acetate
0143-9597	Abiraterone	Abiraterone acetate
47335-401	YONSA	abiraterone acetate