CaroSpir

Product NDC
17856-0120
11-digit product format
178560120
Labeler code
17856
Product ID
17856-0120_16683cbd-f833-40d0-ae1b-6526c06f6276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CaroSpir
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA209478
Marketing category
NDA
Marketing start
2018-08-22
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/5mL
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0120-12024-04-12C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960
17856-0120-12024-01-30C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960
17856-0120-12022-03-11C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960
17856-0120-12022-01-28C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960
17856-0120-12020-05-20C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960
17856-0120-12020-01-31C16284748780-19d75b9d0-634f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CAROSPIR ® safely and effectively. See full prescribing information for CAROSPIR ® . CAROSPIR ® (spironolactone) Oral Suspension, for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0120-1CaroSpir72 in 1 BOXSuspension724
17856-0120-2CaroSpir2.5 mL in 1 CUPSuspension2.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0120CAROSPIR SUSPENSION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 2 package rows20240415_07504afc-f0b6-40f6-8719-cd1c3e67fc35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSN07504afc-f0b6-40f6-8719-cd1c3e67fc354
104232spironolactone 5 MG/ML Oral SuspensionSCD07504afc-f0b6-40f6-8719-cd1c3e67fc354
104232spironolactone 25 MG per 5 ML Oral SuspensionSY07504afc-f0b6-40f6-8719-cd1c3e67fc354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0120-11785601200172 CUP in 1 BOX (17856-0120-1) > 2.5 mL in 1 CUP (17856-0120-2) 72 cup2020-05-200000-00-00NoNoCurrent
17856-0120-2178560120022.5 mL in 1 CUP2.5 mlHistorical