FDA.reportPublic FDA data

CARVEDILOL

Product NDC
72789-440
11-digit product format
727890440
Labeler code
72789
Product ID
72789-440_4d7b0386-3253-2606-e063-6294a90a668b
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
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
Rxcui200033

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
72789-440-90CARVEDILOL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
72789-440-93CARVEDILOL180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-440-90EA - Each72789-440e5ef8bfe-5f9e-4f04-adfb-b197a51d954d12024-12-10
72789-440-93EA - Each72789-44031610884-00cb-4457-8c2f-e7938b626e4a12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-440CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20241105_9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96
200033carvedilol 25 MG Oral TabletSCD9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-440-907278904409090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-90) 2024-11-04NoNoCurrent
72789-440-9372789044093180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-93) 2024-10-11NoNoCurrent