FDA.reportPublic FDA data

CARVEDILOL

Product NDC
68788-8231
11-digit product format
687888231
Labeler code
68788
Product ID
68788-8231_e591fdd8-b68b-460b-ae74-8c23b8f65d91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078165
Marketing category
ANDA
Marketing start
2022-08-08
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
68788-8231-1CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED1004
68788-8231-3CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED304
68788-8231-9CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8231-1EA - Each68788-82316fbe9b61-a7ec-464a-ba4b-9169d74c32cb12022-09-12
68788-8231-9EA - Each68788-82314d25bb0f-88eb-47e6-b625-8e819dece4d512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8231CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250216_8d3937b4-e0dd-4165-9825-bbf5020d79f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN8d3937b4-e0dd-4165-9825-bbf5020d79f94
200033carvedilol 25 MG Oral TabletSCD8d3937b4-e0dd-4165-9825-bbf5020d79f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8231-168788823101100 TABLET, FILM COATED in 1 BOTTLE (68788-8231-1) 2022-08-080000-00-00NoNoCurrent
68788-8231-36878882310330 TABLET, FILM COATED in 1 BOTTLE (68788-8231-3) 2022-08-080000-00-00NoNoCurrent
68788-8231-96878882310990 TABLET, FILM COATED in 1 BOTTLE (68788-8231-9) 2024-03-21NoNoHistorical