FDA.reportPublic FDA data

Carvedilol

Product NDC
68071-2230
11-digit product format
680712230
Labeler code
68071
Product ID
68071-2230_2ac0f53e-48b2-5d84-e063-6294a90a8ac8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare 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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2230-82022-02-07C16284748780-1d6a99b39-5e95-a426-e053-dadaa90af4c2These 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
68071-2230-82022-01-28C16284748780-1d6a99b39-5e95-a426-e053-dadaa90af4c2These 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
68071-2230-3Carvedilol180 in 1 BOTTLETABLET, FILM COATED1807
68071-2230-6Carvedilol60 in 1 BOTTLETABLET, FILM COATED607
68071-2230-8Carvedilol180 in 1 BOTTLETABLET, FILM COATED1807
68071-2230-9Carvedilol90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2230CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20250104_ac14846e-423a-37c4-e053-2a95a90a3cdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNac14846e-423a-37c4-e053-2a95a90a3cdd7
200032carvedilol 12.5 MG Oral TabletSCDac14846e-423a-37c4-e053-2a95a90a3cdd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2230-368071223003180 TABLET, FILM COATED in 1 BOTTLE (68071-2230-3) 2025-01-02NoNoHistorical
68071-2230-66807122300660 TABLET, FILM COATED in 1 BOTTLE (68071-2230-6) 2020-08-040000-00-00NoNoCurrent
68071-2230-868071223008180 TABLET, FILM COATED in 1 BOTTLE (68071-2230-8) 2020-08-040000-00-00NoNoCurrent
68071-2230-96807122300990 TABLET, FILM COATED in 1 BOTTLE (68071-2230-9) 2020-08-04NoNoHistorical