Drug Information

Product NDC: 59310-302

Proprietary Name: QVAR REDIHALER

Non Proprietary Name: Beclomethasone Dipropionate HFA

Active Ingredient(s):

Administration Route(s): RESPIRATORY (INHALATION)

Dosage Form(s): AEROSOL, METERED

Pharmacy Class(es):
  • Corticosteroid [EPC];
  • Corticosteroid Hormone Receptor Agonists [MoA]

Labeler Information

Labeler Name: Teva Respiratory, LLC
FDA Application Number: NDA207921
Marketing Category: NDA
Start Marketing Date:2/15/2018

Package Information

No. Package Code Package Description Billing Unit
159310-302-401 INHALER in 1 CARTON (59310-302-40) > 1 CANISTER in 1 INHALER > 120 AEROSOL, METERED in 1 CANISTERGM
259310-302-411 INHALER in 1 CARTON (59310-302-41) > 1 CANISTER in 1 INHALER > 120 AEROSOL, METERED in 1 CANISTER

NDC Record

Field Name Field Value Definition
PRODUCT NDC59310-302The 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 NAMEQVAR REDIHALERThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBeclomethasone Dipropionate HFAThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEAEROSOL, METEREDThe 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 DATE2/15/2018This 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 NUMBERNDA207921This 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 NAMETeva Respiratory, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBECLOMETHASONE DIPROPIONATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 

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This page was last updated on: 10/4/2019