63402-681 NDC - UTIBRON NEOHALER (INDACATEROL MALEATE AND GLYCOPYRROLATE)

Drug Information

Product NDC: 63402-681

Proprietary Name: UTIBRON NEOHALER

Non Proprietary Name: INDACATEROL MALEATE and GLYCOPYRROLATE

Active Ingredient(s):
  • 27.5 ug/1 INDACATEROL MALEATE;
  • 15.6 ug/1 GLYCOPYRROLATE


Administration Route(s): RESPIRATORY (INHALATION)

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • Adrenergic beta2-Agonists [MoA];
  • beta2-Adrenergic Agonist [EPC];
  • Anticholinergic [EPC];
  • Cholinergic Antagonists [MoA]

Labeler Information

Labeler Name: Sunovion Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA207930
Marketing Category: NDA
Start Marketing Date:10/29/2015

Package Information

No. Package Code Package Description Billing Unit
163402-681-061 BLISTER PACK in 1 CARTON (63402-681-06) > 6 CAPSULE in 1 BLISTER PACK (63402-681-01) > 1 CAPSULE in 1 CAPSULEEA
263402-681-122 BLISTER PACK in 1 CARTON (63402-681-12) > 6 CAPSULE in 1 BLISTER PACK (63402-681-02) > 1 CAPSULE in 1 CAPSULE
363402-681-6010 BLISTER PACK in 1 CARTON (63402-681-60) > 6 CAPSULE in 1 BLISTER PACK (63402-681-01) > 1 CAPSULE in 1 CAPSULEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC63402-681The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEUTIBRON NEOHALERThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEINDACATEROL MALEATE and GLYCOPYRROLATEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERESPIRATORY (INHALATION)The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/29/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA207930This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMESunovion Pharmaceuticals Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEINDACATEROL MALEATE; GLYCOPYRROLATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH27.5; 15.6 
ACTIVE INGRED UNITug/1; ug/1 
PHARM CLASSESAdrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 

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This page was last updated on: 6/17/2019