FDA.reportPublic FDA data

Carvedilol

Product NDC
63629-4060
11-digit product format
636294060
Labeler code
63629
Product ID
63629-4060_50f1e9cf-e25a-454d-acbb-113f4bdec411
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4060-1Carvedilol30 in 1 BOTTLETABLET, FILM COATED3016
63629-4060-2Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
63629-4060-3Carvedilol180 in 1 BOTTLETABLET, FILM COATED18016
63629-4060-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED6016
63629-4060-5Carvedilol90 in 1 BOTTLETABLET, FILM COATED9016
63629-4060-6Carvedilol120 in 1 BOTTLETABLET, FILM COATED12016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4060-1EA - Each63629-4060f8784a95-c4ca-4e01-85cd-90c89194f0e512012-07-24
63629-4060-2EA - Each63629-4060a575fca5-25f7-41c7-a53c-5267f6d1340f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4060CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 6 package rows20240511_b23021d4-c00a-e0ef-eb93-1dc824ae56ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNb23021d4-c00a-e0ef-eb93-1dc824ae56ca16
686924carvedilol 3.125 MG Oral TabletSCDb23021d4-c00a-e0ef-eb93-1dc824ae56ca16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4060-16362940600130 TABLET, FILM COATED in 1 BOTTLE (63629-4060-1) 2009-08-270000-00-00NoNoCurrent
63629-4060-263629406002100 TABLET, FILM COATED in 1 BOTTLE (63629-4060-2) 2009-09-040000-00-00NoNoCurrent
63629-4060-363629406003180 TABLET, FILM COATED in 1 BOTTLE (63629-4060-3) 2015-11-240000-00-00NoNoCurrent
63629-4060-46362940600460 TABLET, FILM COATED in 1 BOTTLE (63629-4060-4) 2011-05-020000-00-00NoNoCurrent
63629-4060-56362940600590 TABLET, FILM COATED in 1 BOTTLE (63629-4060-5) 2014-05-300000-00-00NoNoCurrent
63629-4060-663629406006120 TABLET, FILM COATED in 1 BOTTLE (63629-4060-6) 2014-10-280000-00-00NoNoCurrent