Carvedilol

Product NDC
82804-225
11-digit product format
828040225
Labeler code
82804
Product ID
82804-225_da2696ba-f4be-4626-9abe-fe33f36361b1
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
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
82804-225-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-225-90EA - Each82804-22542b66675-5d27-476a-8f71-b2d0b506455612025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-225CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 1 package rows20250529_da2696ba-f4be-4626-9abe-fe33f36361b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNda2696ba-f4be-4626-9abe-fe33f36361b11
200032carvedilol 12.5 MG Oral TabletSCDda2696ba-f4be-4626-9abe-fe33f36361b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-225-908280402259090 TABLET, FILM COATED in 1 BOTTLE (82804-225-90) 2025-05-22NoNoCurrent