FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-2175
11-digit product format
500902175
Labeler code
50090
Product ID
50090-2175_adb37b64-cfc9-4575-b0c2-c449c0b38799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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, 200032, 200033, 686924

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
50090-2175-02023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-12023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-22023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-32023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-42023-02-06C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-02023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-12023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-22023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-32023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-42023-01-30C16284748780-1f386c649-f2dc-0266-e053-dadaa90a7c1aThese 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
50090-2175-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED6041
50090-2175-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED18041
50090-2175-2Carvedilol100 in 1 BOTTLETABLET, FILM COATED10041
50090-2175-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED3041
50090-2175-4Carvedilol90 in 1 BOTTLETABLET, FILM COATED9041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2175-0EA - Each50090-217574b97045-f1e1-475e-a922-8d30792d8b4312019-02-13
50090-2175-1EA - Each50090-2175198dbf6c-347f-48d3-8d1b-a4ad0ddbcc1412018-11-06
50090-2175-3EA - Each50090-21752c1b83d5-542b-4723-ba27-410f3ae5937412018-11-06
50090-2175-4EA - Each50090-217568254db6-a6dc-4eed-9a11-9b4fec5ed49212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2175CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]36Current NDC, Legacy NDC, 5 package rows20241003_ee848543-12fb-446c-86db-bf2322ec986f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200033carvedilol 25 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
686924carvedilol 3.125 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200031carvedilol 6.25 MG Oral TabletPSNee848543-12fb-446c-86db-bf2322ec986f41
200032carvedilol 12.5 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
200033carvedilol 25 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
686924carvedilol 3.125 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41
200031carvedilol 6.25 MG Oral TabletSCDee848543-12fb-446c-86db-bf2322ec986f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2175-05009021750060 TABLET, FILM COATED in 1 BOTTLE (50090-2175-0) 2015-10-230000-00-00NoNoCurrent
50090-2175-150090217501180 TABLET, FILM COATED in 1 BOTTLE (50090-2175-1) 2015-10-230000-00-00NoNoCurrent
50090-2175-250090217502100 TABLET, FILM COATED in 1 BOTTLE (50090-2175-2) 2015-10-230000-00-00NoNoCurrent
50090-2175-35009021750330 TABLET, FILM COATED in 1 BOTTLE (50090-2175-3) 2015-10-230000-00-00NoNoCurrent
50090-2175-45009021750490 TABLET, FILM COATED in 1 BOTTLE (50090-2175-4) 2015-10-230000-00-00NoNoCurrent