NDC 63402-675

ARCAPTA NEOHALER

Indacaterol Maleate

ARCAPTA NEOHALER is a Oral; Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Indacaterol Maleate.

Product ID63402-675_1250b6c5-cdae-4771-ae60-1463c97cecca
NDC63402-675
Product TypeHuman Prescription Drug
Proprietary NameARCAPTA NEOHALER
Generic NameIndacaterol Maleate
Dosage FormCapsule
Route of AdministrationORAL; RESPIRATORY (INHALATION)
Marketing Start Date2011-07-01
Marketing End Date2021-01-31
Marketing CategoryNDA / NDA
Application NumberNDA022383
Labeler NameSunovion Pharmaceuticals Inc.
Substance NameINDACATEROL MALEATE
Active Ingredient Strength75 ug/1
Pharm ClassesAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 63402-675-30

5 BLISTER PACK in 1 CARTON (63402-675-30) > 6 CAPSULE in 1 BLISTER PACK (63402-675-01)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-675-01 [63402067501]

ARCAPTA NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA022383
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-01
Marketing End Date2021-01-31

NDC 63402-675-30 [63402067530]

ARCAPTA NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA022383
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-01
Marketing End Date2021-01-31

NDC 63402-675-02 [63402067502]

ARCAPTA NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA022383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-01
Marketing End Date2021-01-31

NDC 63402-675-06 [63402067506]

ARCAPTA NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA022383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-01
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
INDACATEROL MALEATE75 ug/1

OpenFDA Data

SPL SET ID:e82416ba-23b9-4d40-a41d-baba8e11751b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1114329
  • 1114333
  • UPC Code
  • 0363402675307
  • 0363402675062
  • Pharmacological Class

    • Adrenergic beta2-Agonists [MoA]
    • beta2-Adrenergic Agonist [EPC]

    Medicade Reported Pricing

    63402067530 ARCAPTA NEOHALER 75 MCG CAP

    Pricing Unit: EA | Drug Type:

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