FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-2555
11-digit product format
500902555
Labeler code
50090
Product ID
50090-2555_88296d3a-412c-45ba-bd33-1ebd1518b572
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
13 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2555-02023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-12023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-22023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-32023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-42023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-02023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-12023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-22023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-32023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-2555-42023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2555-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED6041
50090-2555-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED18041
50090-2555-2Carvedilol100 in 1 BOTTLETABLET, FILM COATED10041
50090-2555-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED9041
50090-2555-4Carvedilol30 in 1 BOTTLETABLET, FILM COATED3041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2555-0EA - Each50090-255588c924a7-29da-4266-997e-17965205f97412019-04-11
50090-2555-1EA - Each50090-2555f1af8057-0d4d-452e-b65f-66daccab6e0812018-11-06
50090-2555-2EA - Each50090-255535e44e64-80bd-4e30-867d-cee4d793d04312018-11-06
50090-2555-3EA - Each50090-2555444c980c-4a5c-4fff-b017-ce5a5a12e4f012018-11-06
50090-2555-4EA - Each50090-255516d07bfe-b316-4c22-ac74-a2175820d13d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2555CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]36Legacy NDC, 5 package rows20241003_ee848543-12fb-446c-86db-bf2322ec986f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200033carvedilol 25 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
686924carvedilol 3.125 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200031carvedilol 6.25 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200032carvedilol 12.5 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
200033carvedilol 25 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
686924carvedilol 3.125 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
200031carvedilol 6.25 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2555-05009025550060 TABLET, FILM COATED in 1 BOTTLE (50090-2555-0) 2016-10-280000-00-00NoNoCurrent
50090-2555-150090255501180 TABLET, FILM COATED in 1 BOTTLE (50090-2555-1) 2016-10-240000-00-00NoNoCurrent
50090-2555-250090255502100 in 1 BOTTLEHistorical
50090-2555-35009025550390 TABLET, FILM COATED in 1 BOTTLE (50090-2555-3) 2016-11-070000-00-00NoNoCurrent
50090-2555-45009025550430 TABLET, FILM COATED in 1 BOTTLE (50090-2555-4) 2016-11-010000-00-00NoNoCurrent