31722-883 : Rosuvastatin 10 mg Oral Tablet, Film Coated

NDC:	31722-883
Labeler:	Camber Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Rosuvastatin
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA207616
Rev. Date:	Oct 29, 2016

Appearance:

Markings:	H;R4
Shapes:	Round
Colors:	Pink
Size (mm):	6
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:

• 31722-883-31: 100 TABLET, FILM COATED IN 1 CARTON (31722‑883‑31)
• 31722-883-90: 90 TABLET, FILM COATED IN 1 BOTTLE (31722‑883‑90)

Active Ingredients:

• Rosuvastatin Calcium

Inactive Ingredients:

• Crospovidone
• Fd&c Blue No. 2
• Fd&c Red No. 40
• Hydroxypropyl Cellulose
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Sodium Bicarbonate
• Talc
• Titanium Dioxide
• Triacetin
• Fd&c Yellow No. 6

Pharmaceutical Classes:

• HMG-CoA Reductase Inhibitor [EPC]
• Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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