FDA.reportPublic FDA data

Carvedilol

Product NDC
68462-163
11-digit product format
684620163
Labeler code
68462
Product ID
68462-163_5f5b2d20-cc2a-4e91-b2b9-260e7438ab2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-163-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10012
68462-163-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50012
68462-163-10Carvedilol1000 in 1 BOTTLETABLET, FILM COATED100012
68462-163-18Carvedilol180 in 1 BOTTLETABLET, FILM COATED18012
68462-163-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-163-01EA - Each68462-163bcdd23eb-d2e7-417a-ad4c-33bcaf34d92612012-07-24
68462-163-05EA - Each68462-1632b80963c-b279-4ff8-99e5-2336447e973d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]7
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-163CARVEDILOL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]11Current NDC, Legacy NDC, 5 package rows20230831_c4a21f67-7812-4634-beba-f8e85c63c5f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNd7669550-adcc-4e70-83b1-c28ce75e7fda102
200031carvedilol 6.25 MG Oral TabletSCDd7669550-adcc-4e70-83b1-c28ce75e7fda102
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
200032carvedilol 12.5 MG Oral TabletPSNc4a21f67-7812-4634-beba-f8e85c63c5f212
200033carvedilol 25 MG Oral TabletPSNc4a21f67-7812-4634-beba-f8e85c63c5f212
686924carvedilol 3.125 MG Oral TabletPSNc4a21f67-7812-4634-beba-f8e85c63c5f212
200031carvedilol 6.25 MG Oral TabletPSNc4a21f67-7812-4634-beba-f8e85c63c5f212
200032carvedilol 12.5 MG Oral TabletSCDc4a21f67-7812-4634-beba-f8e85c63c5f212
200033carvedilol 25 MG Oral TabletSCDc4a21f67-7812-4634-beba-f8e85c63c5f212
686924carvedilol 3.125 MG Oral TabletSCDc4a21f67-7812-4634-beba-f8e85c63c5f212
200031carvedilol 6.25 MG Oral TabletSCDc4a21f67-7812-4634-beba-f8e85c63c5f212
200032carvedilol 12.5 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200033carvedilol 25 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
686924carvedilol 3.125 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200031carvedilol 6.25 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200032carvedilol 12.5 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200033carvedilol 25 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
686924carvedilol 3.125 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200031carvedilol 6.25 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200032carvedilol 12.5 MG Oral TabletPSNdd818d91-cddf-474f-aa68-43e416da8b8e3
200033carvedilol 25 MG Oral TabletPSNdd818d91-cddf-474f-aa68-43e416da8b8e3
686924carvedilol 3.125 MG Oral TabletPSNdd818d91-cddf-474f-aa68-43e416da8b8e3
200031carvedilol 6.25 MG Oral TabletPSN84ee5fbf-7299-4b8a-e053-2a91aa0aa1593
200031carvedilol 6.25 MG Oral TabletPSNdd818d91-cddf-474f-aa68-43e416da8b8e3
200032carvedilol 12.5 MG Oral TabletSCDdd818d91-cddf-474f-aa68-43e416da8b8e3
200033carvedilol 25 MG Oral TabletSCDdd818d91-cddf-474f-aa68-43e416da8b8e3
686924carvedilol 3.125 MG Oral TabletSCDdd818d91-cddf-474f-aa68-43e416da8b8e3
200031carvedilol 6.25 MG Oral TabletSCDdd818d91-cddf-474f-aa68-43e416da8b8e3
200031carvedilol 6.25 MG Oral TabletSCD84ee5fbf-7299-4b8a-e053-2a91aa0aa1593
200033carvedilol 25 MG Oral TabletPSNa84e7ab5-bd6a-44a0-bc57-a61b7bc96dc51
200031carvedilol 6.25 MG Oral TabletPSNe0ae5bed-1cb4-45d6-befe-dfc68edb9b341
200031carvedilol 6.25 MG Oral TabletPSNa84e7ab5-bd6a-44a0-bc57-a61b7bc96dc51
200033carvedilol 25 MG Oral TabletSCDa84e7ab5-bd6a-44a0-bc57-a61b7bc96dc51
200031carvedilol 6.25 MG Oral TabletSCDe0ae5bed-1cb4-45d6-befe-dfc68edb9b341
200031carvedilol 6.25 MG Oral TabletSCDa84e7ab5-bd6a-44a0-bc57-a61b7bc96dc51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-163-0168462016301100 TABLET, FILM COATED in 1 BOTTLE (68462-163-01) 2007-09-050000-00-00NoNoCurrent
68462-163-0568462016305500 TABLET, FILM COATED in 1 BOTTLE (68462-163-05) 2007-09-050000-00-00NoNoCurrent
68462-163-10684620163101000 TABLET, FILM COATED in 1 BOTTLE (68462-163-10) 2007-09-050000-00-00NoNoCurrent
68462-163-1868462016318180 TABLET, FILM COATED in 1 BOTTLE (68462-163-18) 2014-12-100000-00-00NoNoCurrent
68462-163-606846201636060 TABLET, FILM COATED in 1 BOTTLE (68462-163-60) 2007-09-050000-00-00NoNoCurrent