FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-5115
11-digit product format
500905115
Labeler code
50090
Product ID
50090-5115_835b01c6-d2bf-41a4-a96a-1a8077bddc3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076373
Marketing category
ANDA
Marketing start
2007-09-06
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
50090-5115-02023-01-30C16284748780-1f386c649-db17-0266-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
50090-5115-12023-01-30C16284748780-1f386c649-db17-0266-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
50090-5115-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED603
50090-5115-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5115CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_52a672a8-db98-4acf-99d5-62eb2977e767.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN52a672a8-db98-4acf-99d5-62eb2977e7673
200032carvedilol 12.5 MG Oral TabletSCD52a672a8-db98-4acf-99d5-62eb2977e7673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5115-05009051150060 TABLET, FILM COATED in 1 BOTTLE (50090-5115-0) 2020-07-310000-00-00NoNoCurrent
50090-5115-150090511501180 TABLET, FILM COATED in 1 BOTTLE (50090-5115-1) 2020-07-310000-00-00NoNoCurrent