Carvedilol

Product NDC
68788-8252
11-digit product format
687888252
Labeler code
68788
Product ID
68788-8252_e743c32b-68b1-4577-a636-59d8a9876d85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2022-09-02
Substance
CARVEDILOL
Active strength
3.125 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
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

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
68788-8252-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED1005
68788-8252-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED305
68788-8252-6Carvedilol60 in 1 BOTTLETABLET, FILM COATED605
68788-8252-8Carvedilol120 in 1 BOTTLETABLET, FILM COATED1205
68788-8252-9Carvedilol90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8252-1EA - Each68788-825216a295c4-2809-4770-b5ee-cc273c50db3b12022-10-06
68788-8252-3EA - Each68788-82524a38e210-000f-4a93-af1b-e65d8f92980812022-10-06
68788-8252-6EA - Each68788-8252eed7733d-3756-4183-9199-4de26d8f7bda12022-10-06
68788-8252-8EA - Each68788-8252838c67fc-7003-4e7e-8653-84616c40d6cb12022-10-06
68788-8252-9EA - Each68788-8252ead3f9da-f3bb-4faa-9ca0-0cfa54be3c5712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8252CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 5 package rows20250215_3b56e0d0-82d7-4512-849f-2b72d7bae36e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN3b56e0d0-82d7-4512-849f-2b72d7bae36e5
686924carvedilol 3.125 MG Oral TabletSCD3b56e0d0-82d7-4512-849f-2b72d7bae36e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8252-168788825201100 TABLET, FILM COATED in 1 BOTTLE (68788-8252-1) 2022-09-020000-00-00NoNoCurrent
68788-8252-36878882520330 TABLET, FILM COATED in 1 BOTTLE (68788-8252-3) 2022-09-020000-00-00NoNoCurrent
68788-8252-66878882520660 TABLET, FILM COATED in 1 BOTTLE (68788-8252-6) 2022-09-020000-00-00NoNoCurrent
68788-8252-868788825208120 TABLET, FILM COATED in 1 BOTTLE (68788-8252-8) 2022-09-020000-00-00NoNoCurrent
68788-8252-96878882520990 TABLET, FILM COATED in 1 BOTTLE (68788-8252-9) 2022-09-020000-00-00NoNoCurrent