Carvedilol

Product NDC: 13107-143
11-digit product format: 131070143
Labeler code: 13107
Product ID: 13107-143_5581f10c-3a75-486e-9c3f-98c2c4df970d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurolife Pharma LLC
Application: ANDA078332
Marketing category: ANDA
Marketing start: 2009-03-23
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 6 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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
32d6365f-9f0e-0782-b719-48e651893fb7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13107-143-01	2019-10-29	C162847	48780-1	960f7f55-d0ee-8e05-e053-dbdaa90a074a	These highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995
13107-143-05	2019-10-29	C162847	48780-1	960f7f55-d0ee-8e05-e053-dbdaa90a074a	These highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995
13107-143-99	2019-10-29	C162847	48780-1	960f7f55-d0ee-8e05-e053-dbdaa90a074a	These highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13107-143-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
13107-143-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
13107-143-99	Carvedilol	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13107-143-01	EA - Each	13107-143	c10dd968-e7b3-4398-8d85-412431178bfd	1	2012-07-24
13107-143-05	EA - Each	13107-143	71a76365-5048-484a-a852-42498d1f1ac1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13107-143	CARVEDILOL TABLET, FILM COATED [AUROLIFE PHARMA LLC]	2	Legacy NDC, 3 package rows	20110627_473d1684-944c-4a65-aef4-6379f97a0178.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K47UL67F2	CARVEDILOL	72956-09-3	CARVEDILOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200031	carvedilol 6.25 MG Oral Tablet	PSN	a27a7950-66d3-4894-8527-2345bb1c7ebc	1000
200031	carvedilol 6.25 MG Oral Tablet	SCD	a27a7950-66d3-4894-8527-2345bb1c7ebc	1000
200031	carvedilol 6.25 MG Oral Tablet	PSN	fd8313e3-7b77-4e44-b2f8-9f504cf1da9f	3
200031	carvedilol 6.25 MG Oral Tablet	SCD	fd8313e3-7b77-4e44-b2f8-9f504cf1da9f	3
200032	carvedilol 12.5 MG Oral Tablet	PSN	473d1684-944c-4a65-aef4-6379f97a0178	2
200033	carvedilol 25 MG Oral Tablet	PSN	473d1684-944c-4a65-aef4-6379f97a0178	2
686924	carvedilol 3.125 MG Oral Tablet	PSN	473d1684-944c-4a65-aef4-6379f97a0178	2
200031	carvedilol 6.25 MG Oral Tablet	PSN	473d1684-944c-4a65-aef4-6379f97a0178	2
200032	carvedilol 12.5 MG Oral Tablet	SCD	473d1684-944c-4a65-aef4-6379f97a0178	2
200033	carvedilol 25 MG Oral Tablet	SCD	473d1684-944c-4a65-aef4-6379f97a0178	2
686924	carvedilol 3.125 MG Oral Tablet	SCD	473d1684-944c-4a65-aef4-6379f97a0178	2
200031	carvedilol 6.25 MG Oral Tablet	SCD	473d1684-944c-4a65-aef4-6379f97a0178	2
200032	carvedilol 12.5 MG Oral Tablet	PSN	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
200033	carvedilol 25 MG Oral Tablet	PSN	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
686924	carvedilol 3.125 MG Oral Tablet	PSN	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
200031	carvedilol 6.25 MG Oral Tablet	PSN	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
200032	carvedilol 12.5 MG Oral Tablet	SCD	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
200033	carvedilol 25 MG Oral Tablet	SCD	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
686924	carvedilol 3.125 MG Oral Tablet	SCD	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1
200031	carvedilol 6.25 MG Oral Tablet	SCD	99f4bdbc-ed07-4c98-a119-94588e53f2ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
13107-143-01	13107014301	100 in 1 BOTTLE	Historical
13107-143-05	13107014305	500 in 1 BOTTLE	Historical
13107-143-99	13107014399	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carvedilol	State of Florida DOH Central Pharmacy	2013-09-05	HUMAN PRESCRIPTION DRUG LABEL	1
Carvedilol	Bryant Ranch Prepack	2013-01-18	HUMAN PRESCRIPTION DRUG LABEL	1000
Carvedilol	Unit Dose Services	2011-06-23	Human Prescription Drug Label	3
Carvedilol	Aurolife Pharma LLC	2011-06-23	Human Prescription Drug Label	2

Carvedilol

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#