0078-0664 : Utibron Neohaler Respiratory (Inhalation) Capsule

Labeler: Novartis Pharmaceuticals Corporation
Product Type: Human Prescription Drug
Drug Name:  Utibron Neohaler
Dosage Form: Respiratory (Inhalation) Capsule
Application #: NDA207930
Rev. Date: 


Shapes:  Capsule
Colors:  Yellow
Size (mm): 16
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:

  • 0078-0664-06: 6 CAPSULE IN 1 BOX, UNIT‑DOSE (0078‑0664‑06)
  • 0078-0664-19: 60 BLISTER PACK IN 1 BOX, UNIT‑DOSE (0078‑0664‑19) > 1 CAPSULE IN 1 BLISTER PACK (0078‑0664‑61)

Active Ingredients:

  • Indacaterol Maleate
  • Glycopyrrolate

Dosage Strength:

  • 27.5 ug/1
  • 15.6 ug/1

Inactive Ingredients:

  • Lactose Monohydrate
  • Magnesium Stearate

Pharmaceutical Classes:

  • Adrenergic beta2-Agonists [MoA]
  • beta2-Adrenergic Agonist [EPC]
  • Anticholinergic [EPC]
  • Cholinergic Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 63402-681 Utibron Neohaler Respiratory (Inhalation) Capsule by Sunovion Pharmaceuticals Inc.


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