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

Labeler: Stat Rx USA LLC
Product Type: Human Prescription Drug
Drug Name:  Aplenzin ER
Dosage Form: Oral Tablet, Extended Release
Application #: NDA022108
Rev. Date: 


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]

Related Products:

Based on records with the same trade name.
  • 0024-5810 24 Hr Aplenzin 174 mg Extended Release Tablet by Sanofi-aventis U.S. LLC
  • 0024-5811 24 Hr Aplenzin 348 mg Extended Release Tablet by Sanofi-aventis U.S. LLC
  • 0024-5812 24 Hr Aplenzin 522 mg Extended Release Tablet by Sanofi-aventis U.S. LLC
  • 0187-5810 Aplenzin 174 mg Oral Tablet, Extended Release by Valeant Pharmaceuticals North America LLC
  • 0187-5811 Aplenzin 348 mg Oral Tablet, Extended Release by Valeant Pharmaceuticals North America LLC
  • 0187-5812 Aplenzin 522 mg Oral Tablet, Extended Release by Valeant Pharmaceuticals North America LLC


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