FDA.reportPublic FDA data

Carvedilol

Product NDC
65862-144
11-digit product format
658620144
Labeler code
65862
Product ID
65862-144_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
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
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
65862-144-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10023
65862-144-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50023
65862-144-99Carvedilol1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-144-01EA - Each65862-1443cf61099-23e3-4958-a9a2-5ea3e258d5b912012-07-24
65862-144-05EA - Each65862-1445f6b57cb-889f-4d16-8213-02ed39cf7d1c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]13
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
carvedilolACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-144CARVEDILOL 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
200032carvedilol 12.5 MG Oral TabletPSN2be8635b-5733-1ed4-e054-00144ff88e8834
200032carvedilol 12.5 MG Oral TabletSCD2be8635b-5733-1ed4-e054-00144ff88e8834
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 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 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
200032carvedilol 12.5 MG Oral TabletPSN8e951b0d-8934-0592-e053-2a95a90a107f2
200032carvedilol 12.5 MG Oral TabletSCD8e951b0d-8934-0592-e053-2a95a90a107f2
200032carvedilol 12.5 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
200032carvedilol 12.5 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200032carvedilol 12.5 MG Oral TabletPSN7f807344-00d9-91d3-e053-2a91aa0a161b1
200033carvedilol 25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
686924carvedilol 3.125 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
200031carvedilol 6.25 MG Oral TabletPSN1da0dc6d-1f09-4888-a04f-c6a8170e2b7b1
200032carvedilol 12.5 MG Oral TabletSCD7f807344-00d9-91d3-e053-2a91aa0a161b1
200032carvedilol 12.5 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391
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
686924carvedilol 3.125 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391
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
65862-144-0165862014401100 TABLET, FILM COATED in 1 BOTTLE (65862-144-01) 2007-09-050000-00-00NoNoCurrent
65862-144-0565862014405500 TABLET, FILM COATED in 1 BOTTLE (65862-144-05) 2007-09-050000-00-00NoNoCurrent
65862-144-99658620144991000 TABLET, FILM COATED in 1 BOTTLE (65862-144-99) 2007-09-050000-00-00NoNoCurrent