FDA.reportPublic FDA data

Carvedilol

Product NDC
68071-4816
11-digit product format
680714816
Labeler code
68071
Product ID
68071-4816_4baef540-88e7-30f4-e063-6294a90acf51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
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
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
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
68071-4816-82024-06-14C16284748780-1ba0f9c33-39f6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CARVEDILOL tablets safely and effectively. See full prescribing information for CARVEDILOL tablets. CARVEDILOL Tablets for oral use Initial U.S. Approval: 1995
68071-4816-82021-01-29C16284748780-1ba0f9c33-39f6-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CARVEDILOL tablets safely and effectively. See full prescribing information for CARVEDILOL tablets. CARVEDILOL Tablets for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4816-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED303
68071-4816-8Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4816CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20240616_84ee5fbf-7299-4b8a-e053-2a91aa0aa159.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN84ee5fbf-7299-4b8a-e053-2a91aa0aa1593
200031carvedilol 6.25 MG Oral TabletSCD84ee5fbf-7299-4b8a-e053-2a91aa0aa1593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-4816-36807148160330 TABLET, FILM COATED in 1 BOTTLE (68071-4816-3) 2026-02-25NoNoCurrent
68071-4816-868071481608180 TABLET, FILM COATED in 1 BOTTLE (68071-4816-8) 2019-03-25NoNoCurrent