CARVEDILOL

Product NDC
72888-035
11-digit product format
728880035
Labeler code
72888
Product ID
72888-035_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
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
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
CARVEDILOL6.25 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
72888-035-00CARVEDILOL1000 in 1 BOTTLETABLET, FILM COATED10003
72888-035-01CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED1003
72888-035-05CARVEDILOL500 in 1 BOTTLETABLET, FILM COATED5003
72888-035-30CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-035-00EA - Each72888-035512ed092-67ac-47ee-ab90-be6b1601295812021-10-08
72888-035-01EA - Each72888-035b8cbec26-5322-46b3-81bb-90e5900caa4512021-11-09
72888-035-05EA - Each72888-0353720cd6e-aa15-4599-aa60-3fd0b8a9638412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-035CARVEDILOL 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
200031carvedilol 6.25 MG Oral TabletPSNfe462198-32ae-4f6c-befc-acb97fb017c9103
200031carvedilol 6.25 MG Oral TabletSCDfe462198-32ae-4f6c-befc-acb97fb017c9103
200031carvedilol 6.25 MG Oral TabletPSN95300809-be15-461e-904e-b56aba6769754
200031carvedilol 6.25 MG Oral TabletSCD95300809-be15-461e-904e-b56aba6769754
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-035-00728880035001000 TABLET, FILM COATED in 1 BOTTLE (72888-035-00) 2021-07-290000-00-00NoNoCurrent
72888-035-0172888003501100 TABLET, FILM COATED in 1 BOTTLE (72888-035-01) 2021-07-290000-00-00NoNoCurrent
72888-035-0572888003505500 TABLET, FILM COATED in 1 BOTTLE (72888-035-05) 2021-07-290000-00-00NoNoCurrent
72888-035-307288800353030 TABLET, FILM COATED in 1 BOTTLE (72888-035-30) 2021-07-290000-00-00NoNoCurrent