43353-875 : Simvastatin 5 mg Oral Tablet, Film Coated

NDC:	43353-875
Labeler:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	Human Prescription Drug
Drug Name:	Simvastatin
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA077691
Rev. Date:	Dec 20, 2006

Appearance:

Markings:	A;15
Shapes:	Round
Colors:	Yellow
Size (mm):	5
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.

A 15: (43353-875) Simvastatin 5 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

43353-875-30: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43353‑875‑30)
43353-875-60: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43353‑875‑60)
43353-875-88: 900 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43353‑875‑88)

Active Ingredients:

Simvastatin

Dosage Strength:

5 mg

Inactive Ingredients:

Ascorbic Acid
Lactose Monohydrate
Cellulose, Microcrystalline
Starch, Corn
Hydroxypropyl Cellulose
Hypromellose 2910 (6 Mpa.s)
Titanium Dioxide
Talc
Citric Acid Monohydrate
Isopropyl Alcohol
Magnesium Stearate
Butylated Hydroxyanisole
Ferric Oxide Yellow

Pharmaceutical Classes:

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

NDC QR Code

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NDC 43353-875 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.