Carvedilol

Product NDC
68382-093
11-digit product format
683820093
Labeler code
68382
Product ID
68382-093_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
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
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
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
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
68382-093-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
68382-093-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50016
68382-093-17Carvedilol28 in 1 BOTTLETABLET, FILM COATED2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-093-01EA - Each68382-09365fe8b7c-016e-41fd-ba44-ef23ad751cce12012-07-24
68382-093-05EA - Each68382-0932db6956a-406e-44d8-825e-584e7a63748f12012-07-24

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 [PROFICIENT RX LP]1
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]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
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [H.J. HARKINS COMPANY, 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
68382-093CARVEDILOL 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
200031carvedilol 6.25 MG Oral TabletPSNda830b08-1cdd-4d36-a068-c376fd7763c4104
200031carvedilol 6.25 MG Oral TabletSCDda830b08-1cdd-4d36-a068-c376fd7763c4104
200031carvedilol 6.25 MG Oral TabletPSN683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb20
200031carvedilol 6.25 MG Oral TabletSCD683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb20
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
200031carvedilol 6.25 MG Oral TabletPSNed60e2e4-6eda-4728-aec4-263b821e4ed88
200031carvedilol 6.25 MG Oral TabletSCDed60e2e4-6eda-4728-aec4-263b821e4ed88
200031carvedilol 6.25 MG Oral TabletPSN64ba2b17-989e-443c-8277-9649489b5ce86
200031carvedilol 6.25 MG Oral TabletSCD64ba2b17-989e-443c-8277-9649489b5ce86
200031carvedilol 6.25 MG Oral TabletPSNd5822e3c-413c-4c7e-bbec-d0d42d2028ba4
200031carvedilol 6.25 MG Oral TabletPSNe31271aa-259b-caa6-e053-2995a90a0fcd4
200031carvedilol 6.25 MG Oral TabletPSNa570b8ea-530d-4565-a091-bb9dbe4a6d8d4
200031carvedilol 6.25 MG Oral TabletSCDd5822e3c-413c-4c7e-bbec-d0d42d2028ba4
200031carvedilol 6.25 MG Oral TabletSCDa570b8ea-530d-4565-a091-bb9dbe4a6d8d4
200031carvedilol 6.25 MG Oral TabletSCDe31271aa-259b-caa6-e053-2995a90a0fcd4
200031carvedilol 6.25 MG Oral TabletPSN4c48ba6b-4e1e-5116-e063-6394a90aa7931
200031carvedilol 6.25 MG Oral TabletPSNad96f237-1e3a-45ff-9c47-fed3544dc9431
200031carvedilol 6.25 MG Oral TabletPSNed11cd4e-d7c9-8446-e053-2995a90afd6e1
200031carvedilol 6.25 MG Oral TabletPSN51b403dc-fc9f-0cad-e063-6394a90af0811
200031carvedilol 6.25 MG Oral TabletSCDad96f237-1e3a-45ff-9c47-fed3544dc9431
200031carvedilol 6.25 MG Oral TabletSCD51b403dc-fc9f-0cad-e063-6394a90af0811
200031carvedilol 6.25 MG Oral TabletSCDed11cd4e-d7c9-8446-e053-2995a90afd6e1
200031carvedilol 6.25 MG Oral TabletSCD4c48ba6b-4e1e-5116-e063-6394a90aa7931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-093-0168382009301100 TABLET, FILM COATED in 1 BOTTLE (68382-093-01) 2007-09-050000-00-00NoNoCurrent
68382-093-0568382009305500 TABLET, FILM COATED in 1 BOTTLE (68382-093-05) 2007-09-050000-00-00NoNoCurrent
68382-093-176838200931728 TABLET, FILM COATED in 1 BOTTLE (68382-093-17) 2007-09-050000-00-00NoNoCurrent