FDA.reportPublic FDA data

Carvedilol

Product NDC
68382-092
11-digit product format
683820092
Labeler code
68382
Product ID
68382-092_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
3.125 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
CARVEDILOL3.125 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
c09e7fc3-90f5-4f9d-96f4-e1a857de4102Product name120230718
36aa7500-f1f6-4316-9cf2-688d1cdea23aProduct name120190402
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
15592b85-0e03-4d08-b78d-bef98f30a3f5Product name120180529
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-092-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
68382-092-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50016
68382-092-17Carvedilol28 in 1 BOTTLETABLET, FILM COATED2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-092-01EA - Each68382-09265cec951-d2e7-49b5-86c3-eb3a06650caf12012-07-24
68382-092-05EA - Each68382-092b62f293d-1ebe-47e7-9c4c-60ecc3723e4912012-07-24

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 [BRYANT RANCH PREPACK]2
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOLEVULINIC ACID HYDROCHLORIDEINACTIVE INGREDIENTV35KBM8JGRCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOMETRADINEINACTIVE INGREDIENTPPM8SX5Q3VCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPENTAMIDE SULFATEINACTIVE INGREDIENT20P9NI883OCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPHYLLINEINACTIVE INGREDIENT27Y3KJK423CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPROMAZINEINACTIVE INGREDIENTS9SDD93U5UCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPROPAZINE FUMARATEINACTIVE INGREDIENT9KWA4W69IWCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMINOPTERIN SODIUMINACTIVE INGREDIENTFZU1QI13O9CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMMI VISNAGA FRUITINACTIVE INGREDIENT3UN285QN0CCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
AMOPROXANINACTIVE INGREDIENT27RL57FCYMCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]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
68382-092CARVEDILOL 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
686924carvedilol 3.125 MG Oral TabletPSN32098c09-7580-4975-a3e1-31b619c04c6919
686924carvedilol 3.125 MG Oral TabletPSN444ee05c-571a-4ea6-8763-af05d252df5619
686924carvedilol 3.125 MG Oral TabletSCD32098c09-7580-4975-a3e1-31b619c04c6919
686924carvedilol 3.125 MG Oral TabletSCD444ee05c-571a-4ea6-8763-af05d252df5619
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
686924carvedilol 3.125 MG Oral TabletPSNb23021d4-c00a-e0ef-eb93-1dc824ae56ca16
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
686924carvedilol 3.125 MG Oral TabletSCDb23021d4-c00a-e0ef-eb93-1dc824ae56ca16
200031carvedilol 6.25 MG Oral TabletSCDdc6a2d33-aa04-4a04-9cde-901b744d24ca16
686924carvedilol 3.125 MG Oral TabletPSN3eb4fd8e-1027-4d24-8f2f-12e9dcfe62319
686924carvedilol 3.125 MG Oral TabletSCD3eb4fd8e-1027-4d24-8f2f-12e9dcfe62319
686924carvedilol 3.125 MG Oral TabletPSN3b56e0d0-82d7-4512-849f-2b72d7bae36e5
686924carvedilol 3.125 MG Oral TabletPSN0bfea06d-7abe-407a-80a4-d15d373569f75
686924carvedilol 3.125 MG Oral TabletPSNadd1ee3d-fca4-4301-b871-7dda6eda7bb75
686924carvedilol 3.125 MG Oral TabletPSN010290af-81f4-0037-e063-6394a90a46385
686924carvedilol 3.125 MG Oral TabletSCDadd1ee3d-fca4-4301-b871-7dda6eda7bb75
686924carvedilol 3.125 MG Oral TabletSCD010290af-81f4-0037-e063-6394a90a46385
686924carvedilol 3.125 MG Oral TabletSCD3b56e0d0-82d7-4512-849f-2b72d7bae36e5
686924carvedilol 3.125 MG Oral TabletSCD0bfea06d-7abe-407a-80a4-d15d373569f75
686924carvedilol 3.125 MG Oral TabletPSN49afdf89-0bed-71da-e054-00144ff88e884
686924carvedilol 3.125 MG Oral TabletPSNf2a0407c-2e05-60eb-e053-2a95a90abc994
686924carvedilol 3.125 MG Oral TabletSCD49afdf89-0bed-71da-e054-00144ff88e884
686924carvedilol 3.125 MG Oral TabletSCDf2a0407c-2e05-60eb-e053-2a95a90abc994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-092-0168382009201100 TABLET, FILM COATED in 1 BOTTLE (68382-092-01) 2007-09-050000-00-00NoNoCurrent
68382-092-0568382009205500 TABLET, FILM COATED in 1 BOTTLE (68382-092-05) 2007-09-050000-00-00NoNoCurrent
68382-092-176838200921728 TABLET, FILM COATED in 1 BOTTLE (68382-092-17) 2007-09-050000-00-00NoNoCurrent