FDA.reportPublic FDA data

Carvedilol

Product NDC
42708-072
11-digit product format
427080072
Labeler code
42708
Product ID
42708-072_45b3b81e-d875-5d61-e063-6394a90ad20a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA076373
Marketing category
ANDA
Marketing start
2007-09-06
Substance
CARVEDILOL
Active strength
3.125 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

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
42708-072-602021-03-12C16284748780-1ba0f9c33-5b53-a910-e053-dadaa90a0b85These 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
42708-072-602021-01-29C16284748780-1ba0f9c33-5b53-a910-e053-dadaa90a0b85These 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
42708-072-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-072CARVEDILOL TABLET, FILM COATED [QPHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20241127_ffbedcce-0d64-4aed-9e65-09448d71ca91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNffbedcce-0d64-4aed-9e65-09448d71ca916
686924carvedilol 3.125 MG Oral TabletSCDffbedcce-0d64-4aed-9e65-09448d71ca916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-072-604270800726060 TABLET, FILM COATED in 1 BOTTLE (42708-072-60) 2018-04-180000-00-00YesNoCurrent