NDC 0078-0664

UTIBRON NEOHALER

Indacaterol And Glycopyrrolate

UTIBRON NEOHALER is a Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Indacaterol Maleate; Glycopyrrolate.

• Product ID: 0078-0664_77de1b47-3665-4fb2-b7a5-31dcbcd63622
• NDC: 0078-0664
• Product Type: Human Prescription Drug
• Proprietary Name: UTIBRON NEOHALER
• Generic Name: Indacaterol And Glycopyrrolate
• Dosage Form: Capsule
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2015-10-29
• Marketing End Date: 2019-06-30
• Marketing Category: NDA / NDA
• Application Number: NDA207930
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: INDACATEROL MALEATE; GLYCOPYRROLATE
• Active Ingredient Strength: 28 ug/1; ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0078-0664-19

60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0664-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0664-61)

• Marketing Start Date: 2015-10-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0664-19 [00078066419]

UTIBRON NEOHALER CAPSULE

• Marketing Category: NDA
• Application Number: NDA207930
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-29
• Marketing End Date: 2019-06-30

NDC 0078-0664-61 [00078066461]

UTIBRON NEOHALER CAPSULE

• Marketing Category: NDA
• Application Number: NDA207930
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-29
• Marketing End Date: 2019-06-30

NDC 0078-0664-06 [00078066406]

UTIBRON NEOHALER CAPSULE

• Marketing Category: NDA
• Application Number: NDA207930
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-29
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
INDACATEROL MALEATE	27.5 ug/1

OpenFDA Data

• SPL SET ID: 7782a48e-38bb-404a-94ef-051278d8bfef
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • V92SO9WP2I
  • 2JEC1ITX7R
• RxNorm Concept Unique ID - RxCUI:
  • 1720953
  • 1720948

Pharmacological Class

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

NDC Crossover Matching brand name "UTIBRON NEOHALER" or generic name "Indacaterol And Glycopyrrolate"

NDC	Brand Name	Generic Name
0078-0664	UTIBRON NEOHALER	indacaterol and glycopyrrolate
63402-681	UTIBRON NEOHALER	INDACATEROL MALEATE and GLYCOPYRROLATE