NDC 0378-6921

Abiraterone Acetate

Abiraterone Acetate

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

Product ID0378-6921_16cd9ff7-86d7-49ab-8579-7be174844486
NDC0378-6921
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone Acetate
Generic NameAbiraterone Acetate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-12-14
Marketing CategoryANDA / ANDA
Application NumberANDA208446
Labeler NameMylan Pharmaceuticals Inc.
Substance NameABIRATERONE ACETATE
Active Ingredient Strength500 mg/1
Pharm ClassesCytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-6921-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91)
Marketing Start Date2020-12-14
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0093-1125Abiraterone AcetateAbiraterone Acetate
0378-6920Abiraterone Acetateabiraterone acetate
0378-6921Abiraterone Acetateabiraterone acetate
0378-6924Abiraterone Acetateabiraterone acetate
0904-6948Abiraterone AcetateAbiraterone Acetate
16714-963Abiraterone AcetateAbiraterone Acetate
42291-024Abiraterone AcetateAbiraterone
42291-073ABIRATERONE ACETATEABIRATERONE
42292-057Abiraterone Acetateabiraterone acetate
43598-358Abiraterone AcetateAbiraterone Acetate
69238-1165Abiraterone AcetateAbiraterone Acetate
51407-181Abiraterone AcetateAbiraterone Acetate
57894-199Abiraterone acetateAbiraterone acetate
57894-155Abiraterone acetateAbiraterone acetate
60505-4327Abiraterone AcetateAbiraterone Acetate
64679-021Abiraterone acetateAbiraterone acetate
64980-418Abiraterone acetateAbiraterone acetate
60687-455Abiraterone AcetateAbiraterone Acetate
72606-566Abiraterone acetateAbiraterone acetate
68462-135abiraterone acetateabiraterone acetate
0143-9597AbirateroneAbiraterone acetate
47335-401YONSAabiraterone acetate

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