Carvedilol

Product NDC
43063-125
11-digit product format
430630125
Labeler code
43063
Product ID
43063-125_41375a05-871b-6afb-e063-6294a90a48f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078332
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
12.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200032

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
43063-125-90Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9034
43063-125-93Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18034

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-125CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]33Current NDC, Legacy NDC, 2 package rows20240809_2be8635b-5733-1ed4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN2be8635b-5733-1ed4-e054-00144ff88e8834
200032carvedilol 12.5 MG Oral TabletSCD2be8635b-5733-1ed4-e054-00144ff88e8834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-125-904306301259090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-125-90) 2024-07-31NoNoCurrent
43063-125-9343063012593180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-125-93) 2012-06-200000-00-00NoNoCurrent