FDA.reportPublic FDA data

QVAR REDIHALER

Product NDC
50090-5032
11-digit product format
500905032
Labeler code
50090
Product ID
50090-5032_778908c5-aa3d-496b-b530-9a5da5eebc6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Beclomethasone Dipropionate HFA
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA207921
Marketing category
NDA
Marketing start
2018-02-15
Substance
BECLOMETHASONE DIPROPIONATE
Active strength
80 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
QVAR REDIHALER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BECLOMETHASONE DIPROPIONATE80 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5B307S63B2
Rxcui1998771, 1998772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
56560def-9e4f-4cea-995d-33e9e282a050Product name120171204
7cc1653a-dc36-45c2-8752-61a7a3967d75Product name120170829
e97c5025-cafa-043f-50a3-771ab2b84660Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5032-02023-09-21C16284748780-1f386c64a-19d1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976
50090-5032-02023-01-30C16284748780-1f386c64a-19d1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5032-0QVAR REDIHALER1 in 1 INHALERAEROSOL, METERED18
50090-5032-0QVAR REDIHALER1 in 1 CARTONAEROSOL, METERED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5032-0GM - Gram50090-5032d7925eea-fdf2-4cc7-8c7f-27ef6000f28f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5032QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20230921_2814cf81-392e-4dd4-9816-ae7e6e5ec84f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998772Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]SBD2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998771Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCD2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998772Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose InhalerSY2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY2814cf81-392e-4dd4-9816-ae7e6e5ec84f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5032-0500905032001 INHALER in 1 CARTON (50090-5032-0) / 1 AEROSOL, METERED in 1 INHALER1 inhaler2020-04-300000-00-00NoNoCurrent