43598-358 : Abiraterone Acetate 250 mg Oral Tablet

NDC:	43598-358
Labeler:	Dr. Reddys Laboratories Inc
Product Type:	Human Prescription Drug
Drug Name:	Abiraterone Acetate
Dosage Form:	Oral Tablet
Application #:	ANDA208416
Rev. Date:	May 19, 2020

Appearance:

Markings:	35
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:

• 43598-358-04: 120 TABLET IN 1 BOTTLE (43598‑358‑04)
• 43598-358-31: 3 BLISTER PACK IN 1 CARTON (43598‑358‑31) / 10 TABLET IN 1 BLISTER PACK (43598‑358‑79)

Active Ingredients:

• Abiraterone Acetate

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycol, Unspecified
• Povidone
• Sodium Lauryl Sulfate
• Titanium Dioxide /

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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