FDA.reportPublic FDA data

CaroSpir

Product NDC
46287-020
11-digit product format
462870020
Labeler code
46287
Product ID
46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CaroSpir
Dosage form
SUSPENSION
Route
ORAL
Labeler
CMP Pharma, Inc.
Application
NDA209478
Marketing category
NDA
Marketing start
2017-08-04
Substance
SPIRONOLACTONE
Active strength
25 mg/5mL
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CaroSpir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui104232

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46287-020-01CaroSpir473 mL in 1 BOTTLESuspension4737
46287-020-04CaroSpir118 mL in 1 BOTTLESuspension1187
46287-020-50CaroSpir10 in 1 CARTONSuspension107
46287-020-50CaroSpir5 mL in 1 CUP, UNIT-DOSESuspension57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46287-020-01ML - Milliliter46287-0205b06e9a1-7b5e-46c0-8094-6e576124114612017-10-13
46287-020-04ML - Milliliter46287-020f02de24e-3ebd-434e-ba96-d0e0b1112bff12017-10-13
46287-020-50ML - Milliliter46287-0202a238b32-32a9-4ae7-a483-ed5198ef83d912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46287-020CAROSPIR SUSPENSION [CMP PHARMA, INC.]6Current NDC, Legacy NDC, 4 package rows20230910_c4f70a04-7d89-4b73-8b02-17d43471bf08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104232spironolactone 25 MG in 5 mL Oral SuspensionPSNc4f70a04-7d89-4b73-8b02-17d43471bf087
104232spironolactone 5 MG/ML Oral SuspensionSCDc4f70a04-7d89-4b73-8b02-17d43471bf087
104232spironolactone 25 MG per 5 ML Oral SuspensionSYc4f70a04-7d89-4b73-8b02-17d43471bf087
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
46287-020-0146287002001473 mL in 1 BOTTLE (46287-020-01) 473 ml2017-08-040000-00-00NoNoCurrent
46287-020-0446287002004118 mL in 1 BOTTLE (46287-020-04) 118 ml2017-08-040000-00-00NoNoCurrent
46287-020-504628700205010 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE2021-07-150000-00-00NoNoCurrent