FDA.reportPublic FDA data

Carvedilol

Product NDC
65862-145
11-digit product format
658620145
Labeler code
65862
Product ID
65862-145_f210723f-29fb-46c7-8ac4-5009d9696d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078332
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
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
CARVEDILOL25 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-145-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10023
65862-145-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50023
65862-145-99Carvedilol1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-145CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 3 package rows20240608_7cc14b86-0833-4c3c-91f3-7963d7052fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSNfe4aa7f0-6ef2-4a95-8a64-5e3365f10474103
200033carvedilol 25 MG Oral TabletSCDfe4aa7f0-6ef2-4a95-8a64-5e3365f10474103
200033carvedilol 25 MG Oral TabletPSN205da5d0-05d9-440d-bb5a-b30b826900ab31
200033carvedilol 25 MG Oral TabletSCD205da5d0-05d9-440d-bb5a-b30b826900ab31
200032carvedilol 12.5 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200033carvedilol 25 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200031carvedilol 6.25 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200032carvedilol 12.5 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200033carvedilol 25 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200031carvedilol 6.25 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200032carvedilol 12.5 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200033carvedilol 25 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
686924carvedilol 3.125 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200031carvedilol 6.25 MG Oral TabletPSN7cc14b86-0833-4c3c-91f3-7963d7052fd523
200032carvedilol 12.5 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200033carvedilol 25 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
686924carvedilol 3.125 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200031carvedilol 6.25 MG Oral TabletSCD7cc14b86-0833-4c3c-91f3-7963d7052fd523
200032carvedilol 12.5 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
200033carvedilol 25 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
686924carvedilol 3.125 MG Oral TabletPSN4d56592a-d9be-441c-9200-eab9018ec31213
200032carvedilol 12.5 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
200033carvedilol 25 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
686924carvedilol 3.125 MG Oral TabletSCD4d56592a-d9be-441c-9200-eab9018ec31213
200032carvedilol 12.5 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200033carvedilol 25 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
686924carvedilol 3.125 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200031carvedilol 6.25 MG Oral TabletPSN213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200032carvedilol 12.5 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200033carvedilol 25 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
686924carvedilol 3.125 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200031carvedilol 6.25 MG Oral TabletSCD213f1d2e-65a4-4cad-91e9-85c0fc65ac9412
200032carvedilol 12.5 MG Oral TabletPSNcd7e7c34-6958-47be-a1c1-f1ed948e26875
200033carvedilol 25 MG Oral TabletPSNcd7e7c34-6958-47be-a1c1-f1ed948e26875
200032carvedilol 12.5 MG Oral TabletSCDcd7e7c34-6958-47be-a1c1-f1ed948e26875
200033carvedilol 25 MG Oral TabletSCDcd7e7c34-6958-47be-a1c1-f1ed948e26875
200032carvedilol 12.5 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200033carvedilol 25 MG Oral TabletPSNd3992a3f-8347-476d-993e-16958c74efb33
200033carvedilol 25 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
686924carvedilol 3.125 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200031carvedilol 6.25 MG Oral TabletPSN264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200032carvedilol 12.5 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200033carvedilol 25 MG Oral TabletSCDd3992a3f-8347-476d-993e-16958c74efb33
200033carvedilol 25 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
686924carvedilol 3.125 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200031carvedilol 6.25 MG Oral TabletSCD264a3dc1-596c-43ab-a20c-65c80ab22f2a3
200033carvedilol 25 MG Oral TabletPSN8e955ac9-d12b-06a2-e053-2a95a90ab77a2
200033carvedilol 25 MG Oral TabletPSN8e95a97f-9ccd-b58b-e053-2a95a90a2fbf2
200033carvedilol 25 MG Oral TabletSCD8e95a97f-9ccd-b58b-e053-2a95a90a2fbf2
200033carvedilol 25 MG Oral TabletSCD8e955ac9-d12b-06a2-e053-2a95a90ab77a2
200032carvedilol 12.5 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200033carvedilol 25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200031carvedilol 6.25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200032carvedilol 12.5 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200033carvedilol 25 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200031carvedilol 6.25 MG Oral TabletSCD1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-145-0165862014501100 TABLET, FILM COATED in 1 BOTTLE (65862-145-01) 2007-09-050000-00-00NoNoCurrent
65862-145-0565862014505500 TABLET, FILM COATED in 1 BOTTLE (65862-145-05) 2007-09-050000-00-00NoNoCurrent
65862-145-39658620145393000 TABLET, FILM COATED in 1 BAG (65862-145-39)05-SEP-07Current
65862-145-99658620145991000 TABLET, FILM COATED in 1 BOTTLE (65862-145-99) 2007-09-050000-00-00NoNoCurrent