FDA.reportPublic FDA data

Carvedilol

Product NDC
68788-0254
11-digit product format
687880254
Labeler code
68788
Product ID
68788-0254_cb8b6e75-6865-4f77-924c-147774e15e31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA076649
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
E
Listing certified through
2017-12-31
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
68788-0254-02019-11-27C16284748780-19855d018-deaa-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0254-32019-11-27C16284748780-19855d018-deaa-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0254-62019-11-27C16284748780-19855d018-deaa-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0254-82019-11-27C16284748780-19855d018-deaa-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0254-92019-11-27C16284748780-19855d018-deaa-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0254-0Carvedilol100 in 1 BOTTLETABLET, FILM COATED10011
68788-0254-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED3011
68788-0254-6Carvedilol60 in 1 BOTTLETABLET, FILM COATED6011
68788-0254-8Carvedilol120 in 1 BOTTLETABLET, FILM COATED12011
68788-0254-9Carvedilol90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0254CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11Legacy NDC, 5 package rows20130501_506005f3-d79d-4de1-8bd2-71ade18b8d47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN506005f3-d79d-4de1-8bd2-71ade18b8d4711
200032carvedilol 12.5 MG Oral TabletSCD506005f3-d79d-4de1-8bd2-71ade18b8d4711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-0254-068788025400100 in 1 BOTTLEHistorical
68788-0254-36878802540330 in 1 BOTTLEHistorical
68788-0254-66878802540660 in 1 BOTTLEHistorical
68788-0254-868788025408120 in 1 BOTTLEHistorical
68788-0254-96878802540990 in 1 BOTTLEHistorical