FDA.reportPublic FDA data

Carvedilol

Product NDC
68071-2633
11-digit product format
680712633
Labeler code
68071
Product ID
68071-2633_d6f8af0e-660f-191c-e053-2995a90a45fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078384
Marketing category
ANDA
Marketing start
2016-10-01
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
3 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
2023-12-31
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
68071-2633-32025-01-30C16284748780-12cef2736-7581-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995
68071-2633-62025-01-30C16284748780-12cef2736-7581-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995
68071-2633-82025-01-30C16284748780-12cef2736-7581-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995
68071-2633-92025-01-30C16284748780-12cef2736-7581-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2633-3Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68071-2633-6Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68071-2633-8Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
68071-2633-9Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2633CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 4 package rows20220202_d6f8af0e-660e-191c-e053-2995a90a45fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNd6f8af0e-660e-191c-e053-2995a90a45fc1
686924carvedilol 3.125 MG Oral TabletSCDd6f8af0e-660e-191c-e053-2995a90a45fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2633-36807126330330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2633-3) 2022-02-010000-00-00NoNoCurrent
68071-2633-66807126330660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2633-6) 2022-02-010000-00-00NoNoCurrent
68071-2633-868071263308180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2633-8) 2022-02-010000-00-00NoNoCurrent
68071-2633-96807126330990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-2633-9) 2022-02-010000-00-00NoNoCurrent