16590-922 : 24 Hr Aplenzin 348 mg Extended Release Tablet

NDC:	16590-922
Labeler:	Stat Rx USA LLC
Product Type:	Human Prescription Drug
Drug Name:	Aplenzin ER
Dosage Form:	Oral Tablet, Extended Release
Application #:	NDA022108
Rev. Date:	Mar 30, 2009

Appearance:

Markings:	BR;348
Shapes:	Round
Colors:	White
Size (mm):	8
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:

16590-922-30: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (16590‑922‑30)
16590-922-60: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (16590‑922‑60)
16590-922-90: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (16590‑922‑90)

Active Ingredients:

Bupropion Hydrobromide

Dosage Strength:

348 mg

Inactive Ingredients:

Ethylcellulose (100 Mpa.s)
Glyceryl Behenate
Polyvinyl Alcohol
Polyethylene Glycol
Povidone
Dibutyl Sebacate
Carnauba Wax

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 16590-922 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.