0115-1385 : Ezetimibe and Simvastatin Oral Tablet, Film Coated

NDC:	0115-1385
Labeler:	Impax Generics
Product Type:	Human Prescription Drug
Drug Name:	Ezetimibe and Simvastatin
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA201890
Rev. Date:	Apr 26, 2017

Appearance:

Markings:	P61;P61
Shapes:	Oval
Colors:	Pink
Size (mm):	15
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:

0115-1385-03: 1000 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑03)
0115-1385-08: 30 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑08)
0115-1385-10: 90 TABLET, FILM COATED IN 1 BOTTLE (0115‑1385‑10)

Active Ingredients:

Ezetimibe
Simvastatin

Dosage Strength:

10 mg
10 mg

Inactive Ingredients:

Ascorbic Acid
Butylated Hydroxyanisole
Anhydrous Citric Acid
Starch, Corn
Croscarmellose Sodium
Hypromellose 2910 (6 Mpa.s)
Lactose Monohydrate
Magnesium Stearate
Cellulose, Microcrystalline
Polyethylene Glycol 3350
Talc
Titanium Dioxide
Fd&c Red No. 40
Fd&c Blue No. 2

Pharmaceutical Classes:

Decreased Cholesterol Absorption [PE]
Dietary Cholesterol Absorption Inhibitor [EPC]
HMG-CoA Reductase Inhibitor [EPC]
Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC QR Code

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NDC 0115-1385 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.