0093-1125 : Abiraterone Acetate 250 mg Oral Tablet, Film Coated

NDC:	0093-1125
Labeler:	Teva Pharmaceuticals USA, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Abiraterone Acetate
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA208432
Rev. Date:	Nov 21, 2018

Appearance:

Markings:	TEVA;1125
Shapes:	Oval
Colors:	White
Size (mm):	16
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 0093-1125-89: 120 TABLET, FILM COATED IN 1 BOTTLE (0093‑1125‑89)

Active Ingredients:

• Abiraterone Acetate

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Lactose Monohydrate
• Magnesium Stearate
• Polyethylene Glycol 3350
• Polyethylene Glycol 4000
• Povidone K30
• Sodium Lauryl Sulfate
• Talc
• Titanium Dioxide
• Microcrystalline Cellulose
• Polyvinyl Alcohol, Unspecified /

Pharmaceutical Classes:

• Cytochrome P450 17A1 Inhibitors [MoA]
• Cytochrome P450 17A1 Inhibitor [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]

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