FDA.reportPublic FDA data

QVAR REDIHALER

Product NDC
59310-304
11-digit product format
593100304
Labeler code
59310
Product ID
59310-304_9b314255-e511-463f-9cf2-6812cb638cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Beclomethasone Dipropionate HFA
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Teva Respiratory, LLC
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, 1998773, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59310-304-80QVAR REDIHALER1 in 1 INHALERAEROSOL, METERED116
59310-304-80QVAR REDIHALER1 in 1 CARTONAEROSOL, METERED116
59310-304-81QVAR REDIHALER1 in 1 INHALERAEROSOL, METERED116
59310-304-81QVAR REDIHALER1 in 1 CARTONAEROSOL, METERED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59310-304-80GM - Gram59310-304a9104e75-919c-41f1-bc69-52b39be1e97f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59310-304QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [TEVA RESPIRATORY, LLC]14Current NDC, Legacy NDC, 4 package rows20240202_cada897a-264e-450d-ae00-36e7fe747080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNccd3aaec-4892-40d0-ad60-3e570178fbe131
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNccd3aaec-4892-40d0-ad60-3e570178fbe131
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNccd3aaec-4892-40d0-ad60-3e570178fbe131
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNccd3aaec-4892-40d0-ad60-3e570178fbe131
1998774Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler [Qvar]SBDccd3aaec-4892-40d0-ad60-3e570178fbe131
1998772Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]SBDccd3aaec-4892-40d0-ad60-3e570178fbe131
1998773Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose InhalerSCDccd3aaec-4892-40d0-ad60-3e570178fbe131
1998771Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCDccd3aaec-4892-40d0-ad60-3e570178fbe131
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998774Breath-Actuated 120 ACTUAT Qvar 0.04 MG/ACTUAT Metered Dose InhalerSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998772Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose InhalerSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYccd3aaec-4892-40d0-ad60-3e570178fbe131
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNcada897a-264e-450d-ae00-36e7fe74708016
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNcada897a-264e-450d-ae00-36e7fe74708016
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNcada897a-264e-450d-ae00-36e7fe74708016
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSNcada897a-264e-450d-ae00-36e7fe74708016
1998774Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler [Qvar]SBDcada897a-264e-450d-ae00-36e7fe74708016
1998772Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]SBDcada897a-264e-450d-ae00-36e7fe74708016
1998773Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose InhalerSCDcada897a-264e-450d-ae00-36e7fe74708016
1998771Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCDcada897a-264e-450d-ae00-36e7fe74708016
1998773beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYcada897a-264e-450d-ae00-36e7fe74708016
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYcada897a-264e-450d-ae00-36e7fe74708016
1998774Breath-Actuated 120 ACTUAT Qvar 0.04 MG/ACTUAT Metered Dose InhalerSYcada897a-264e-450d-ae00-36e7fe74708016
1998772Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose InhalerSYcada897a-264e-450d-ae00-36e7fe74708016
1998774QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYcada897a-264e-450d-ae00-36e7fe74708016
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSYcada897a-264e-450d-ae00-36e7fe74708016
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 ACTUATPSN2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
1998772QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATPSN2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
1998772Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]SBD2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
1998771Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose InhalerSCD2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
1998771beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUATSY2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
1998772Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose InhalerSY2814cf81-392e-4dd4-9816-ae7e6e5ec84f8
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
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
59310-304-80593100304801 INHALER in 1 CARTON (59310-304-80) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER1 inhaler2018-02-150000-00-00NoNoCurrent
59310-304-81593100304811 INHALER in 1 CARTON (59310-304-81) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER1 inhaler2018-02-150000-00-00YesNoCurrent