Carvedilol

Product NDC
63187-424
11-digit product format
631870424
Labeler code
63187
Product ID
63187-424_bb200a44-7b5a-475f-aebb-e9e132f00a21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
6.25 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
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c09e7fc3-90f5-4f9d-96f4-e1a857de4102Product name120230718
36aa7500-f1f6-4316-9cf2-688d1cdea23aProduct name120190402
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
15592b85-0e03-4d08-b78d-bef98f30a3f5Product name120180529
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-424-30Carvedilol30 in 1 BOTTLETABLET, FILM COATED304
63187-424-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-424-30EA - Each63187-42403e109b1-ae4b-4175-93c8-95e5f5622fbf12026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOLEVULINIC ACID HYDROCHLORIDEINACTIVE INGREDIENTV35KBM8JGRCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOMETRADINEINACTIVE INGREDIENTPPM8SX5Q3VCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPENTAMIDE SULFATEINACTIVE INGREDIENT20P9NI883OCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPHYLLINEINACTIVE INGREDIENT27Y3KJK423CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPROMAZINEINACTIVE INGREDIENTS9SDD93U5UCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPROPAZINE FUMARATEINACTIVE INGREDIENT9KWA4W69IWCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPTERIN SODIUMINACTIVE INGREDIENTFZU1QI13O9CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMMI VISNAGA FRUITINACTIVE INGREDIENT3UN285QN0CCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMOPROXANINACTIVE INGREDIENT27RL57FCYMCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-424CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 2 package rows20210115_d5822e3c-413c-4c7e-bbec-d0d42d2028ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNd5822e3c-413c-4c7e-bbec-d0d42d2028ba4
200031carvedilol 6.25 MG Oral TabletSCDd5822e3c-413c-4c7e-bbec-d0d42d2028ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-424-306318704243030 TABLET, FILM COATED in 1 BOTTLE (63187-424-30) 2025-12-05NoNoCurrent
63187-424-606318704246060 TABLET, FILM COATED in 1 BOTTLE (63187-424-60) 2018-12-010000-00-00NoNoCurrent