Atrovent

Product NDC
53002-8410
11-digit product format
530028410
Labeler code
53002
Product ID
53002-8410_ae30f199-16cf-4645-8ca6-01afb7157083
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA021527
Marketing category
NDA
Marketing start
2005-05-01
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
17 ug/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [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
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-8410-12025-01-30C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12023-06-08C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12023-01-30C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12020-12-17C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004
53002-8410-12020-01-31C16284748780-19d75b9cf-f125-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA inhalation aerosol), for oral inhalation use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-8410-1AtroventHFA1 in 1 CARTONAEROSOL, METERED15
53002-8410-1AtroventHFA200 in 1 CANISTERAEROSOL, METERED2005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8410ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_ae462cd6-615b-4f0d-ae6e-59007e7acab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBDae462cd6-615b-4f0d-ae6e-59007e7acab05
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCDae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-8410-1530028410011 CANISTER in 1 CARTON (53002-8410-1) > 200 AEROSOL, METERED in 1 CANISTER1 canister2018-10-010000-00-00NoNoCurrent