CARVEDILOL

Product NDC
72888-037
11-digit product format
728880037
Labeler code
72888
Product ID
72888-037_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
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
CARVEDILOL25 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
72888-037-00CARVEDILOL1000 in 1 BOTTLETABLET, FILM COATED10003
72888-037-01CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED1003
72888-037-05CARVEDILOL500 in 1 BOTTLETABLET, FILM COATED5003
72888-037-30CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-037-00EA - Each72888-03727841533-da73-47c8-aab1-dfd82353d0bd12021-10-08
72888-037-01EA - Each72888-037b69d8efa-2f40-48a8-8fa5-17c4615e47ca12021-11-09
72888-037-05EA - Each72888-037a4e2d3f3-4ffa-42fa-9ee8-d8069797050b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-037CARVEDILOL 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
200033carvedilol 25 MG Oral TabletPSN1ddff189-1848-4186-bca9-063e4ea7fd1f103
200033carvedilol 25 MG Oral TabletSCD1ddff189-1848-4186-bca9-063e4ea7fd1f103
200033carvedilol 25 MG Oral TabletPSN9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96
200033carvedilol 25 MG Oral TabletSCD9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96
200033carvedilol 25 MG Oral TabletPSN8d3937b4-e0dd-4165-9825-bbf5020d79f94
200033carvedilol 25 MG Oral TabletSCD8d3937b4-e0dd-4165-9825-bbf5020d79f94
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
200033carvedilol 25 MG Oral TabletPSNfcb1de7c-1878-1835-e053-6294a90abe952
200033carvedilol 25 MG Oral TabletPSNfcb2025f-11a1-ea73-e053-6394a90a61cb2
200033carvedilol 25 MG Oral TabletSCDfcb1de7c-1878-1835-e053-6294a90abe952
200033carvedilol 25 MG Oral TabletSCDfcb2025f-11a1-ea73-e053-6394a90a61cb2
200033carvedilol 25 MG Oral TabletPSN947baca7-f9c8-4821-b47b-53c45288613e1
200033carvedilol 25 MG Oral TabletPSN5eeeaeee-9698-493f-9aa7-d130681472081
200033carvedilol 25 MG Oral TabletSCD947baca7-f9c8-4821-b47b-53c45288613e1
200033carvedilol 25 MG Oral TabletSCD5eeeaeee-9698-493f-9aa7-d130681472081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-037-00728880037001000 TABLET, FILM COATED in 1 BOTTLE (72888-037-00) 2021-07-290000-00-00NoNoCurrent
72888-037-0172888003701100 TABLET, FILM COATED in 1 BOTTLE (72888-037-01) 2021-07-290000-00-00NoNoCurrent
72888-037-0572888003705500 TABLET, FILM COATED in 1 BOTTLE (72888-037-05) 2021-07-290000-00-00NoNoCurrent
72888-037-307288800373030 TABLET, FILM COATED in 1 BOTTLE (72888-037-30) 2021-07-290000-00-00NoNoCurrent