Coreg

Product NDC
80725-140
11-digit product format
807250140
Labeler code
80725
Product ID
80725-140_f2798247-00df-4ec2-a6f8-1902f10b5558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Waylis Therapeutics LLC
Application
NDA020297
Marketing category
NDA
Marketing start
2023-03-15
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
Coreg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 212388, 212389, 212390, 686924, 686926

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
80725-140-20Coreg100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80725-140-20EA - Each80725-14041bff2cb-89bd-4458-ad5a-adaeca73aa6012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80725-140COREG (CARVEDILOL) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC]2Current NDC, 1 package rows20250126_07c619c6-4a0c-445e-94fa-664a54f68a39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
200033carvedilol 25 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
686924carvedilol 3.125 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
200031carvedilol 6.25 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
212389COREG 12.5 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
212390COREG 25 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
686926COREG 3.125 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
212388COREG 6.25 MG Oral TabletPSN07c619c6-4a0c-445e-94fa-664a54f68a392
212389carvedilol 12.5 MG Oral Tablet [Coreg]SBD07c619c6-4a0c-445e-94fa-664a54f68a392
212390carvedilol 25 MG Oral Tablet [Coreg]SBD07c619c6-4a0c-445e-94fa-664a54f68a392
686926carvedilol 3.125 MG Oral Tablet [Coreg]SBD07c619c6-4a0c-445e-94fa-664a54f68a392
212388carvedilol 6.25 MG Oral Tablet [Coreg]SBD07c619c6-4a0c-445e-94fa-664a54f68a392
200032carvedilol 12.5 MG Oral TabletSCD07c619c6-4a0c-445e-94fa-664a54f68a392
200033carvedilol 25 MG Oral TabletSCD07c619c6-4a0c-445e-94fa-664a54f68a392
686924carvedilol 3.125 MG Oral TabletSCD07c619c6-4a0c-445e-94fa-664a54f68a392
200031carvedilol 6.25 MG Oral TabletSCD07c619c6-4a0c-445e-94fa-664a54f68a392
212389Coreg 12.5 MG Oral TabletSY07c619c6-4a0c-445e-94fa-664a54f68a392
212390Coreg 25 MG Oral TabletSY07c619c6-4a0c-445e-94fa-664a54f68a392
686926Coreg 3.125 Oral TabletSY07c619c6-4a0c-445e-94fa-664a54f68a392
212388Coreg 6.25 MG Oral TabletSY07c619c6-4a0c-445e-94fa-664a54f68a392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80725-140-2080725014020100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-140-20) 2023-04-15NoNoHistorical