FDA.reportPublic FDA data

Carvedilol

Product NDC
63187-946
11-digit product format
631870946
Labeler code
63187
Product ID
63187-946_d327c98b-8ef9-4355-b49d-664413f4158e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078332
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
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-946-30Carvedilol30 in 1 BOTTLETABLET, FILM COATED305
63187-946-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED605
63187-946-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-946-60EA - Each63187-9460aec7c66-a467-4b14-b1de-8eb007cacde612018-05-09
63187-946-90EA - Each63187-946cef0fc3a-dc66-4357-8c49-da3db4cac91512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-946CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220525_36230cc8-e808-4f74-a27d-4367eecd21f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN36230cc8-e808-4f74-a27d-4367eecd21f75
200031carvedilol 6.25 MG Oral TabletSCD36230cc8-e808-4f74-a27d-4367eecd21f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-946-306318709463030 TABLET, FILM COATED in 1 BOTTLE (63187-946-30) 2018-01-010000-00-00NoNoCurrent
63187-946-606318709466060 TABLET, FILM COATED in 1 BOTTLE (63187-946-60) 2018-01-010000-00-00NoNoCurrent
63187-946-906318709469090 TABLET, FILM COATED in 1 BOTTLE (63187-946-90) 2018-01-010000-00-00NoNoCurrent