0078-0664 : Utibron Neohaler Respiratory (Inhalation) Capsule


NDC0078-0664
Labeler: Novartis Pharmaceuticals Corporation
Product Type: Human Prescription Drug
Drug Name:  Utibron Neohaler
Dosage Form: Respiratory (Inhalation) Capsule
Application #: NDA207930
Rev. Date: 


Appearance:


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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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.