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 ID69539-049_19fc3e14-b31a-42d4-99fb-3f554f9424e5
NDC69539-049
Product TypeHuman Prescription Drug
Proprietary NameAbiraterone
Generic NameAbiraterone Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA210686
Labeler NameMSN LABORATORIES PRIVATE LIMITED
Substance NameABIRATERONE ACETATE
Active Ingredient Strength250 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 69539-049-92

120 TABLET in 1 BOTTLE (69539-049-92)
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69539-049-92 [69539004992]

Abiraterone TABLET
Marketing CategoryANDA
Application NumberANDA210686
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
ABIRATERONE ACETATE250 mg/1

OpenFDA Data

SPL SET ID:0a84f388-a8b4-4065-93a6-1c663c99d265
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0143-9597AbirateroneAbiraterone acetate
    69539-049AbirateroneAbiraterone
    72205-030AbirateroneAbiraterone
    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
    47335-401YONSAabiraterone acetate

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