Carvedilol

Product NDC
82804-138
11-digit product format
828040138
Labeler code
82804
Product ID
82804-138_baaecdf7-b67a-47f3-b42a-caf413bb9f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076373
Marketing category
ANDA
Marketing start
2007-09-06
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
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
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
82804-138-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED602
82804-138-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-138CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 2 package rows20240907_52785a22-ddca-4f5b-8579-5974df2a9a4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN52785a22-ddca-4f5b-8579-5974df2a9a4e2
200033carvedilol 25 MG Oral TabletSCD52785a22-ddca-4f5b-8579-5974df2a9a4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-138-608280401386060 TABLET, FILM COATED in 1 BOTTLE (82804-138-60) 2025-12-04NoNoCurrent
82804-138-908280401389090 TABLET, FILM COATED in 1 BOTTLE (82804-138-90) 2024-09-06NoNoCurrent