43353-538 : Bupropion Hydrochloride 100 mg Oral Tablet, Film Coated, Extended Release

NDC:	43353-538
Labeler:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	Human Prescription Drug
Drug Name:	Bupropion Hydrochloride
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA079095
Rev. Date:	Jul 2, 2009

Appearance:

Markings:	WPI;858
Shapes:	Round
Colors:	White
Size (mm):	10
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.

WPI 858: (43353-538) Bupropion Hydrochloride 100 mg Oral Tablet, Film Coated, Extended Release 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:

43353-538-16: 6000 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43353‑538‑16)
43353-538-82: 1200 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (43353‑538‑82)

Active Ingredients:

Bupropion Hydrochloride

Dosage Strength:

100 mg

Inactive Ingredients:

Hydroxypropyl Cellulose (Type H)
Cellulose, Microcrystalline
Silicon Dioxide
Stearic Acid
Magnesium Stearate
Hydrochloric Acid
Lactose Monohydrate
Titanium Dioxide
Polyethylene Glycols

Pharmaceutical Classes:

Aminoketone [EPC]
Dopamine Uptake Inhibitors [MoA]
Increased Dopamine Activity [PE]
Increased Norepinephrine Activity [PE]
Norepinephrine Uptake Inhibitors [MoA]

NDC QR Code

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NDC 43353-538 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.