Carvedilol

Product NDC
63187-570
11-digit product format
631870570
Labeler code
63187
Product ID
63187-570_7a3df1e2-dfa6-44b3-a2cc-0fb9adc28ae3
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
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
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
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
63187-570-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED605
63187-570-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-570-90EA - Each63187-5701402b8ba-921c-401e-a213-c134e5012d2712024-12-10

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
63187-570CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20240726_0bfea06d-7abe-407a-80a4-d15d373569f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN0bfea06d-7abe-407a-80a4-d15d373569f75
686924carvedilol 3.125 MG Oral TabletSCD0bfea06d-7abe-407a-80a4-d15d373569f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-570-306318705703030 TABLET, FILM COATED in 1 BOTTLE (63187-570-30) 2018-12-010000-00-00NoNoCurrent
63187-570-606318705706060 TABLET, FILM COATED in 1 BOTTLE (63187-570-60) 2018-12-010000-00-00NoNoCurrent
63187-570-906318705709090 TABLET, FILM COATED in 1 BOTTLE (63187-570-90) 2018-12-010000-00-00NoNoCurrent