FDA.reportPublic FDA data

Carvedilol

Product NDC
68382-095
11-digit product format
683820095
Labeler code
68382
Product ID
68382-095_a7e5dd69-ac10-4f36-a366-4ddc1426aef1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077614
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
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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 686924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-095-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
68382-095-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50016
68382-095-17Carvedilol28 in 1 BOTTLETABLET, FILM COATED2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-095-01EA - Each68382-09510e7d1f9-7f8c-4b9f-82c3-5189316bf61e12012-07-24
68382-095-05EA - Each68382-09588524f87-52ed-4c95-96f5-fddfe06ecd8812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOLEVULINIC ACID HYDROCHLORIDEINACTIVE INGREDIENTV35KBM8JGRCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOMETRADINEINACTIVE INGREDIENTPPM8SX5Q3VCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOPENTAMIDE SULFATEINACTIVE INGREDIENT20P9NI883OCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOPHYLLINEINACTIVE INGREDIENT27Y3KJK423CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOPROMAZINEINACTIVE INGREDIENTS9SDD93U5UCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOPROPAZINE FUMARATEINACTIVE INGREDIENT9KWA4W69IWCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMINOPTERIN SODIUMINACTIVE INGREDIENTFZU1QI13O9CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMMI VISNAGA FRUITINACTIVE INGREDIENT3UN285QN0CCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMOPROXANINACTIVE INGREDIENT27RL57FCYMCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOLEVULINIC ACID HYDROCHLORIDEINACTIVE INGREDIENTV35KBM8JGRCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOMETRADINEINACTIVE INGREDIENTPPM8SX5Q3VCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPENTAMIDE SULFATEINACTIVE INGREDIENT20P9NI883OCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPHYLLINEINACTIVE INGREDIENT27Y3KJK423CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPROMAZINEINACTIVE INGREDIENTS9SDD93U5UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPROPAZINE FUMARATEINACTIVE INGREDIENT9KWA4W69IWCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPTERIN SODIUMINACTIVE INGREDIENTFZU1QI13O9CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMMI VISNAGA FRUITINACTIVE INGREDIENT3UN285QN0CCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMOPROXANINACTIVE INGREDIENT27RL57FCYMCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-095CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 3 package rows20231216_dc6a2d33-aa04-4a04-9cde-901b744d24ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200033carvedilol 25 MG Oral TabletPSNdc6a2d33-aa04-4a04-9cde-901b744d24ca16
686924carvedilol 3.125 MG Oral TabletPSNdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200031carvedilol 6.25 MG Oral TabletPSNdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200032carvedilol 12.5 MG Oral TabletSCDdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200033carvedilol 25 MG Oral TabletSCDdc6a2d33-aa04-4a04-9cde-901b744d24ca16
686924carvedilol 3.125 MG Oral TabletSCDdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200031carvedilol 6.25 MG Oral TabletSCDdc6a2d33-aa04-4a04-9cde-901b744d24ca16
200033carvedilol 25 MG Oral TabletPSN81bc612d-5674-45b9-a1f5-2cb4fa62574714
200031carvedilol 6.25 MG Oral TabletPSN81bc612d-5674-45b9-a1f5-2cb4fa62574714
200033carvedilol 25 MG Oral TabletSCD81bc612d-5674-45b9-a1f5-2cb4fa62574714
200031carvedilol 6.25 MG Oral TabletSCD81bc612d-5674-45b9-a1f5-2cb4fa62574714
200033carvedilol 25 MG Oral TabletPSN0e98593a-8424-48c8-acc0-671f4b566aee13
200033carvedilol 25 MG Oral TabletSCD0e98593a-8424-48c8-acc0-671f4b566aee13
200033carvedilol 25 MG Oral TabletPSNdd8b2a3f-c2fa-4859-84a1-c02f2b6087489
200033carvedilol 25 MG Oral TabletSCDdd8b2a3f-c2fa-4859-84a1-c02f2b6087489
200033carvedilol 25 MG Oral TabletPSNf0617fa4-1e87-48fa-947a-e4249153a9478
200033carvedilol 25 MG Oral TabletSCDf0617fa4-1e87-48fa-947a-e4249153a9478
200033carvedilol 25 MG Oral TabletPSNab8aa773-0ed1-4d59-a1bb-f46cf882644f5
200033carvedilol 25 MG Oral TabletPSNb0887c72-bc6a-010d-e053-2995a90aab8d5
200033carvedilol 25 MG Oral TabletSCDb0887c72-bc6a-010d-e053-2995a90aab8d5
200033carvedilol 25 MG Oral TabletSCDab8aa773-0ed1-4d59-a1bb-f46cf882644f5
200032carvedilol 12.5 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200032carvedilol 12.5 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletPSN8ccf07f5-78fb-76da-e053-2a95a90a00903
200033carvedilol 25 MG Oral TabletSCD8ccf07f5-78fb-76da-e053-2a95a90a00903
200033carvedilol 25 MG Oral TabletPSNaae2bafd-460b-4d0c-8d13-8ab0ce6425f71
200033carvedilol 25 MG Oral TabletPSN4c0e089b-0199-43e2-e063-6394a90a78831
200033carvedilol 25 MG Oral TabletSCDaae2bafd-460b-4d0c-8d13-8ab0ce6425f71
200033carvedilol 25 MG Oral TabletSCD4c0e089b-0199-43e2-e063-6394a90a78831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-095-0168382009501100 TABLET, FILM COATED in 1 BOTTLE (68382-095-01) 2007-09-050000-00-00NoNoCurrent
68382-095-0568382009505500 TABLET, FILM COATED in 1 BOTTLE (68382-095-05) 2007-09-050000-00-00NoNoCurrent
68382-095-176838200951728 TABLET, FILM COATED in 1 BOTTLE (68382-095-17) 2007-09-050000-00-00NoNoCurrent