Carvedilol

Product NDC
60760-582
11-digit product format
607600582
Labeler code
60760
Product ID
60760-582_ed11c8f8-fe6a-5ecf-e053-2a95a90a5821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA077614
Marketing category
ANDA
Marketing start
2022-10-17
Substance
CARVEDILOL
Active strength
6.25 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
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031

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
60760-582-60Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-582-60EA - Each60760-58213477f82-4fde-4f02-adce-0a29da01373012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-582CARVEDILOL TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20221110_ed11cd4e-d7c9-8446-e053-2995a90afd6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNed11cd4e-d7c9-8446-e053-2995a90afd6e1
200031carvedilol 6.25 MG Oral TabletSCDed11cd4e-d7c9-8446-e053-2995a90afd6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-582-606076005826060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-582-60) 2022-10-170000-00-00NoNoCurrent