0378-8105 : Galantamine Hydrobromide 8 mg 24 Hr Extended Release Capsule


NDC: 0378-8105
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Galantamine Hydrobromide
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA090900
Rev. Date: 


Appearance:


Markings: MYLAN;GT;8
Shapes:  Capsule
Colors:  Pink / White
Size (mm): 18
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:

  • 0378-8105-10: 1000 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑8105‑10)
  • 0378-8105-93: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑8105‑93)

Active Ingredients:

  • Galantamine Hydrobromide

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Fd&c Red No. 40
  • Gelatin
  • Magnesium Stearate
  • Povidone
  • Sodium Lauryl Sulfate
  • Titanium Dioxide

Pharmaceutical Classes:

  • Cholinesterase Inhibitor [EPC]
  • Cholinesterase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
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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.