NDC 0187-5811

Aplenzin

Bupropion Hydrobromide

Aplenzin is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Bupropion Hydrobromide.

• Product ID: 0187-5811_23b09d2e-0c63-4d09-9612-ed7efd542729
• NDC: 0187-5811
• Product Type: Human Prescription Drug
• Proprietary Name: Aplenzin
• Generic Name: Bupropion Hydrobromide
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-04-23
• Marketing Category: NDA / NDA
• Application Number: NDA022108
• Labeler Name: Bausch Health US, LLC
• Substance Name: BUPROPION HYDROBROMIDE
• Active Ingredient Strength: 348 mg/1
• Pharm Classes: Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0187-5811-07

7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07)

• Marketing Start Date: 2008-04-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-5811-07 [00187581107]

Aplenzin TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022108
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-04-23

NDC 0187-5811-30 [00187581130]

Aplenzin TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022108
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-04-23

Drug Details

Active Ingredients

Ingredient	Strength
BUPROPION HYDROBROMIDE	348 mg/1

OpenFDA Data

• SPL SET ID: 6494d2d9-0ce4-4126-b1c7-49684395942b
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • E70G3G5863
• RxNorm Concept Unique ID - RxCUI:
  • 993552
  • 993550
  • 993683
  • 993681
  • 993569
  • 993567
• UPC Code:
  • 0301875812300

Pharmacological Class

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

NDC Crossover Matching brand name "Aplenzin" or generic name "Bupropion Hydrobromide"

NDC	Brand Name	Generic Name
0187-5810	Aplenzin	bupropion hydrobromide
0187-5811	Aplenzin	bupropion hydrobromide
0187-5812	Aplenzin	bupropion hydrobromide