FDA.reportPublic FDA data

QVAR REDIHALER

Product NDC
50090-5031
11-digit product format
500905031
Labeler code
50090
Product ID
50090-5031_9e31678c-6489-4377-a1b8-8bd6fb54b709
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
40 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 DIPROPIONATE40 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5B307S63B2
Rxcui1998773, 1998774

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
50090-5031-02023-09-21C16284748780-1f386c649-b11a-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
50090-5031-02023-01-30C16284748780-1f386c649-b11a-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
50090-5031-0QVAR REDIHALER1 in 1 INHALERAEROSOL, METERED17
50090-5031-0QVAR REDIHALER1 in 1 CARTONAEROSOL, METERED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5031-0GM - Gram50090-5031d99558a6-5705-48a2-90d1-d4a1db84632112023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5031QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230922_6c19254b-6333-46fa-835b-16b48df57bdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN6c19254b-6333-46fa-835b-16b48df57bdd7
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN6c19254b-6333-46fa-835b-16b48df57bdd7
1998774Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler [Qvar]SBD6c19254b-6333-46fa-835b-16b48df57bdd7
1998773Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose InhalerSCD6c19254b-6333-46fa-835b-16b48df57bdd7
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY6c19254b-6333-46fa-835b-16b48df57bdd7
1998774Breath-Actuated 120 ACTUAT Qvar 0.04 MG/ACTUAT Metered Dose InhalerSY6c19254b-6333-46fa-835b-16b48df57bdd7
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY6c19254b-6333-46fa-835b-16b48df57bdd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5031-0500905031001 INHALER in 1 CARTON (50090-5031-0) / 1 AEROSOL, METERED in 1 INHALER1 inhaler2020-04-300000-00-00NoNoCurrent