CARVEDILOL

Product NDC
72888-034
11-digit product format
728880034
Labeler code
72888
Product ID
72888-034_4b7db91d-a37b-1e8e-e063-6394a90ab2cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CARVEDILOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 686924

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
72888-034-00CARVEDILOL1000 in 1 BOTTLETABLET, FILM COATED10003
72888-034-01CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED1003
72888-034-05CARVEDILOL500 in 1 BOTTLETABLET, FILM COATED5003
72888-034-30CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-034CARVEDILOL TABLET, FILM COATED [ADVAGEN PHARMA LTD]1Current NDC, Legacy NDC, 4 package rows20210818_7a7d3ca1-05b0-4c7e-aefa-492cc441585d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200033carvedilol 25 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
686924carvedilol 3.125 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200031carvedilol 6.25 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200032carvedilol 12.5 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200033carvedilol 25 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
686924carvedilol 3.125 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200031carvedilol 6.25 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
686924carvedilol 3.125 MG Oral TabletPSN4bbf3767-8666-22d8-e063-6294a90a2afe1
686924carvedilol 3.125 MG Oral TabletSCD4bbf3767-8666-22d8-e063-6294a90a2afe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-034-00728880034001000 TABLET, FILM COATED in 1 BOTTLE (72888-034-00) 2021-07-290000-00-00NoNoCurrent
72888-034-0172888003401100 TABLET, FILM COATED in 1 BOTTLE (72888-034-01) 2021-07-290000-00-00NoNoCurrent
72888-034-0572888003405500 TABLET, FILM COATED in 1 BOTTLE (72888-034-05) 2021-07-290000-00-00NoNoCurrent
72888-034-307288800343030 TABLET, FILM COATED in 1 BOTTLE (72888-034-30) 2021-07-290000-00-00NoNoCurrent