NDC 0093-1125

Abiraterone Acetate

Abiraterone Acetate

Abiraterone Acetate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Abiraterone Acetate.

• Product ID: 0093-1125_0e174a8d-2494-4f8d-a3fd-2a70ca6f5d7f
• NDC: 0093-1125
• Product Type: Human Prescription Drug
• Proprietary Name: Abiraterone Acetate
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208432
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• 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 0093-1125-89

120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89)

• Marketing Start Date: 2018-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-1125-89 [00093112589]

Abiraterone Acetate TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA208432
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-21

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	250 mg/1

OpenFDA Data

• SPL SET ID: 0b452d6a-c8fa-4668-9d34-60101a4129f0
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• 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