CARVEDILOL

Product NDC
72789-431
11-digit product format
727890431
Labeler code
72789
Product ID
72789-431_4bc0f6dd-34be-c7d8-e063-6294a90ad065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

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
72789-431-60CARVEDILOL60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-431CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20240921_95300809-be15-461e-904e-b56aba676975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN95300809-be15-461e-904e-b56aba6769754
200031carvedilol 6.25 MG Oral TabletSCD95300809-be15-461e-904e-b56aba6769754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-431-607278904316060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-431-60) 2024-09-19NoNoCurrent