NDC 0378-6920

Abiraterone Acetate

Abiraterone Acetate

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

• Product ID: 0378-6920_03a01309-f4b8-44fd-8778-166d32cde663
• NDC: 0378-6920
• Product Type: Human Prescription Drug
• Proprietary Name: Abiraterone Acetate
• Generic Name: Abiraterone Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA208446
• Labeler Name: Mylan Pharmaceuticals 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: 2020-12-31

Packaging

NDC 0378-6920-78

120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)

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

NDC SPL Data Element Entries

NDC 0378-6920-78 [00378692078]

Abiraterone Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA208446
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-21

NDC 0378-6920-37 [00378692037]

Abiraterone Acetate TABLET

• Marketing Category: ANDA
• Application Number: ANDA208446
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-01
• Marketing End Date: 2019-05-30

Drug Details

Active Ingredients

Ingredient	Strength
ABIRATERONE ACETATE	250 mg/1

OpenFDA Data

• SPL SET ID: fe02db79-fa04-441f-b514-70bd74af6624
• Manufacturer:
  • Mylan Pharmaceuticals 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