FDA.reportPublic FDA data

Carvedilol

Product NDC
50436-2607
11-digit product format
504362607
Labeler code
50436
Product ID
50436-2607_c00f0b75-f25c-426d-b7f4-502b4b46dddd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078332
Marketing category
ANDA
Marketing start
2009-03-23
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
2020-12-31
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
50436-2607-22021-01-29C16284748780-1ba0f9c33-0d27-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995
50436-2607-42021-01-29C16284748780-1ba0f9c33-0d27-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-2607-2Carvedilol60 in 1 BOTTLETABLET, FILM COATED603
50436-2607-4Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-2607CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]3Legacy NDC, 2 package rows20160420_fd8313e3-7b77-4e44-b2f8-9f504cf1da9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNfd8313e3-7b77-4e44-b2f8-9f504cf1da9f3
200031carvedilol 6.25 MG Oral TabletSCDfd8313e3-7b77-4e44-b2f8-9f504cf1da9f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-2607-25043626070260 in 1 BOTTLEHistorical
50436-2607-450436260704180 in 1 BOTTLEHistorical