FDA.reportPublic FDA data

Carvedilol

Product NDC
53808-0827
11-digit product format
538080827
Labeler code
53808
Product ID
53808-0827_61da2442-b0df-44ae-b055-a6aaef3ab5b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076649
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
6 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
2019-12-31
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
53808-0827-12020-01-31C16284748780-19d75b9d1-2ad8-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carvedilol tablets USP safely and effectively. See full prescribing information for Carvedilol Tablets USP. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0827-1Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CarvedilolACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0827CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140404_9b21829b-9a54-4e78-9f44-05456da5ef73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN9b21829b-9a54-4e78-9f44-05456da5ef731
200031carvedilol 6.25 MG Oral TabletSCD9b21829b-9a54-4e78-9f44-05456da5ef731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0827-15380808270130 in 1 BLISTER PACKHistorical