FDA.reportPublic FDA data

Carvedilol

Product NDC
68788-7539
11-digit product format
687887539
Labeler code
68788
Product ID
68788-7539_336e6f60-39b9-4997-b697-873dca01c65f
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
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
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
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
68788-7539-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED1008
68788-7539-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED308
68788-7539-6Carvedilol60 in 1 BOTTLETABLET, FILM COATED608
68788-7539-9Carvedilol90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7539-1EA - Each68788-753907d7100f-cd52-4930-b69e-b25415f0bf3112020-09-14
68788-7539-3EA - Each68788-7539a21fd36d-5521-4208-91f4-d05ffcdcebb812020-09-14
68788-7539-6EA - Each68788-75399a47c196-48ef-4207-82af-dea65519184b12020-09-14
68788-7539-9EA - Each68788-75391e1f1eab-e622-4ac1-8c27-e110c840a73112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7539CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20250216_5c34847d-68f9-4967-81c8-a2297a6acb7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN5c34847d-68f9-4967-81c8-a2297a6acb7f8
200032carvedilol 12.5 MG Oral TabletSCD5c34847d-68f9-4967-81c8-a2297a6acb7f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7539-168788753901100 TABLET, FILM COATED in 1 BOTTLE (68788-7539-1) 2019-12-270000-00-00NoNoCurrent
68788-7539-36878875390330 TABLET, FILM COATED in 1 BOTTLE (68788-7539-3) 2019-12-270000-00-00NoNoCurrent
68788-7539-66878875390660 TABLET, FILM COATED in 1 BOTTLE (68788-7539-6) 2019-12-270000-00-00NoNoCurrent
68788-7539-96878875390990 TABLET, FILM COATED in 1 BOTTLE (68788-7539-9) 2019-12-270000-00-00NoNoCurrent