FDA.reportPublic FDA data

Coreg CR

Product NDC
80725-387
11-digit product format
807250387
Labeler code
80725
Product ID
80725-387_d756f678-86ff-4187-9cc1-68dd3a383af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Waylis Therapeutics LLC
Application
NDA022012
Marketing category
NDA
Marketing start
2022-11-07
Substance
CARVEDILOL PHOSPHATE
Active strength
40 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
Coreg CR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEQT531S367
Rxcui860510, 860512, 860516, 860518, 860522, 860524, 860532, 860534

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
80725-387-13Coreg CR30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-387-13EA - Each80725-38775c2dcca-13b1-47df-b4cd-664b2f10d28f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-387COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [WAYLIS THERAPEUTICS LLC]3Current NDC, 1 package rows20250427_d3625d78-6eb6-41fe-8f6f-664965c104c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860512COREG CR 10 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860518COREG CR 20 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860524Coreg CR 40 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
860534COREG CR 80 MG 24HR Extended Release Oral CapsulePSNd3625d78-6eb6-41fe-8f6f-664965c104c43
86051224 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg]SBDd3625d78-6eb6-41fe-8f6f-664965c104c43
86051824 HR carvedilol phosphate 20 MG Extended Release Oral Capsule [Coreg]SBDd3625d78-6eb6-41fe-8f6f-664965c104c43
86052424 HR carvedilol phosphate 40 MG Extended Release Oral Capsule [Coreg]SBDd3625d78-6eb6-41fe-8f6f-664965c104c43
86053424 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]SBDd3625d78-6eb6-41fe-8f6f-664965c104c43
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDd3625d78-6eb6-41fe-8f6f-664965c104c43
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDd3625d78-6eb6-41fe-8f6f-664965c104c43
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDd3625d78-6eb6-41fe-8f6f-664965c104c43
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDd3625d78-6eb6-41fe-8f6f-664965c104c43
86051224 HR Coreg 10 MG Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
86051824 HR Coreg 20 MG Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
86052424 HR Coreg 40 MG Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
86053424 HR Coreg 80 MG Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860512Coreg CR 10 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860518Coreg CR 20 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860524Coreg CR 40 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43
860534Coreg CR 80 MG 24 HR Extended Release Oral CapsuleSYd3625d78-6eb6-41fe-8f6f-664965c104c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80725-387-138072503871330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-387-13) 2022-11-07NoNoHistorical