FDA.reportPublic FDA data

QVAR REDIHALER

Product NDC
53002-3477
11-digit product format
530023477
Labeler code
53002
Product ID
53002-3477_67896974-da7b-4189-94f3-2f291147678d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Beclomethasone Dipropionate HFA
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA207921
Marketing category
NDA
Marketing start
2018-02-15
Marketing end
0000-00-00
Substance
BECLOMETHASONE DIPROPIONATE
Active strength
80 ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
53002-3477-32025-01-30C16284748780-19d75b9d0-754c-f424-e053-dadaa90a57ceThese 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
53002-3477-32023-06-07C16284748780-19d75b9d0-754c-f424-e053-dadaa90a57ceThese 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
53002-3477-32023-01-30C16284748780-19d75b9d0-754c-f424-e053-dadaa90a57ceThese 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
53002-3477-32020-12-15C16284748780-19d75b9d0-754c-f424-e053-dadaa90a57ceThese 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
53002-3477-32020-01-31C16284748780-19d75b9d0-754c-f424-e053-dadaa90a57ceThese 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
53002-3477-3QVAR REDIHALER1 in 1 INHALERAEROSOL, METERED18
53002-3477-3QVAR REDIHALER1 in 1 CARTONAEROSOL, METERED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3477QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 2 package rows20230609_9fb78667-7db9-4d98-b8a2-0de60458de11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN9fb78667-7db9-4d98-b8a2-0de60458de118
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN9fb78667-7db9-4d98-b8a2-0de60458de118
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN9fb78667-7db9-4d98-b8a2-0de60458de118
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN9fb78667-7db9-4d98-b8a2-0de60458de118
1998774Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler [Qvar]SBD9fb78667-7db9-4d98-b8a2-0de60458de118
1998772Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]SBD9fb78667-7db9-4d98-b8a2-0de60458de118
1998773Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose InhalerSCD9fb78667-7db9-4d98-b8a2-0de60458de118
1998771Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCD9fb78667-7db9-4d98-b8a2-0de60458de118
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY9fb78667-7db9-4d98-b8a2-0de60458de118
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY9fb78667-7db9-4d98-b8a2-0de60458de118
1998774Breath-Actuated 120 ACTUAT Qvar 0.04 MG/ACTUAT Metered Dose InhalerSY9fb78667-7db9-4d98-b8a2-0de60458de118
1998772Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose InhalerSY9fb78667-7db9-4d98-b8a2-0de60458de118
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY9fb78667-7db9-4d98-b8a2-0de60458de118
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY9fb78667-7db9-4d98-b8a2-0de60458de118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3477-3530023477031 INHALER in 1 CARTON (53002-3477-3) > 1 AEROSOL, METERED in 1 INHALER1 inhaler2018-10-010000-00-00NoNoCurrent