FDA.reportPublic FDA data

Carvedilol

Product NDC
68071-5275
11-digit product format
680715275
Labeler code
68071
Product ID
68071-5275_1d7911c7-2be4-aef9-e063-6394a90a6a37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078384
Marketing category
ANDA
Marketing start
2016-10-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5275-82022-02-07C16284748780-1d6a99b39-a8f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995
68071-5275-82022-01-28C16284748780-1d6a99b39-a8f3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use CARVEDILOL TABLETS, USP safely and effectively. See full prescribing information for CARVEDILOL TABLETS, USP, FILM COATED FOR ORAL USE Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5275-8Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5275CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240719_a7bfd0fc-054b-7397-e053-2a95a90ae3e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNa7bfd0fc-054b-7397-e053-2a95a90ae3e23
200031carvedilol 6.25 MG Oral TabletSCDa7bfd0fc-054b-7397-e053-2a95a90ae3e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5275-868071527508180 TABLET, FILM COATED in 1 BOTTLE (68071-5275-8) 2020-06-100000-00-00NoNoCurrent