Carvedilol

Product NDC: 68462-164
11-digit product format: 684620164
Labeler code: 68462
Product ID: 68462-164_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: 12.5 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
Ingredient	Strength
CARVEDILOL	12.5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	0K47UL67F2
Rxcui	200031, 200032, 200033, 686924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
32d6365f-9f0e-0782-b719-48e651893fb7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68462-164-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	12
68462-164-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500	12
68462-164-10	Carvedilol	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	12
68462-164-18	Carvedilol	180 in 1 BOTTLE	TABLET, FILM COATED	180	12
68462-164-60	Carvedilol	60 in 1 BOTTLE	TABLET, FILM COATED	60	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-164-01	EA - Each	68462-164	4691659b-38bd-4d36-badd-fee0d2edbe87	1	2012-07-24
68462-164-05	EA - Each	68462-164	69a98028-e9f2-4237-89fa-a99d0f02f01a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARGININE	ACTIVE INGREDIENT	94ZLA3W45F	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
ARGININE	ACTIVE MOIETY	94ZLA3W45F	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]	2
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-164	CARVEDILOL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	11	Current NDC, Legacy NDC, 5 package rows	20230831_c4a21f67-7812-4634-beba-f8e85c63c5f2.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
200032	carvedilol 12.5 MG Oral Tablet	PSN	ee848543-12fb-446c-86db-bf2322ec986f	41
200033	carvedilol 25 MG Oral Tablet	PSN	ee848543-12fb-446c-86db-bf2322ec986f	41
686924	carvedilol 3.125 MG Oral Tablet	PSN	ee848543-12fb-446c-86db-bf2322ec986f	41
200031	carvedilol 6.25 MG Oral Tablet	PSN	ee848543-12fb-446c-86db-bf2322ec986f	41
200032	carvedilol 12.5 MG Oral Tablet	SCD	ee848543-12fb-446c-86db-bf2322ec986f	41
200033	carvedilol 25 MG Oral Tablet	SCD	ee848543-12fb-446c-86db-bf2322ec986f	41
686924	carvedilol 3.125 MG Oral Tablet	SCD	ee848543-12fb-446c-86db-bf2322ec986f	41
200031	carvedilol 6.25 MG Oral Tablet	SCD	ee848543-12fb-446c-86db-bf2322ec986f	41
200032	carvedilol 12.5 MG Oral Tablet	PSN	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200033	carvedilol 25 MG Oral Tablet	PSN	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
686924	carvedilol 3.125 MG Oral Tablet	PSN	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200031	carvedilol 6.25 MG Oral Tablet	PSN	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200032	carvedilol 12.5 MG Oral Tablet	SCD	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200033	carvedilol 25 MG Oral Tablet	SCD	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
686924	carvedilol 3.125 MG Oral Tablet	SCD	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200031	carvedilol 6.25 MG Oral Tablet	SCD	c4a21f67-7812-4634-beba-f8e85c63c5f2	12
200032	carvedilol 12.5 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200033	carvedilol 25 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
686924	carvedilol 3.125 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200032	carvedilol 12.5 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200033	carvedilol 25 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
686924	carvedilol 3.125 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200032	carvedilol 12.5 MG Oral Tablet	PSN	4400de87-e9c4-4a0e-9275-1715a12ab46d	7
200032	carvedilol 12.5 MG Oral Tablet	SCD	4400de87-e9c4-4a0e-9275-1715a12ab46d	7
200032	carvedilol 12.5 MG Oral Tablet	PSN	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200033	carvedilol 25 MG Oral Tablet	PSN	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
686924	carvedilol 3.125 MG Oral Tablet	PSN	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200031	carvedilol 6.25 MG Oral Tablet	PSN	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200032	carvedilol 12.5 MG Oral Tablet	SCD	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200033	carvedilol 25 MG Oral Tablet	SCD	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
686924	carvedilol 3.125 MG Oral Tablet	SCD	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200031	carvedilol 6.25 MG Oral Tablet	SCD	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	5
200032	carvedilol 12.5 MG Oral Tablet	PSN	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200033	carvedilol 25 MG Oral Tablet	PSN	dd818d91-cddf-474f-aa68-43e416da8b8e	3
686924	carvedilol 3.125 MG Oral Tablet	PSN	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200031	carvedilol 6.25 MG Oral Tablet	PSN	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200032	carvedilol 12.5 MG Oral Tablet	SCD	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200033	carvedilol 25 MG Oral Tablet	SCD	dd818d91-cddf-474f-aa68-43e416da8b8e	3
686924	carvedilol 3.125 MG Oral Tablet	SCD	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200031	carvedilol 6.25 MG Oral Tablet	SCD	dd818d91-cddf-474f-aa68-43e416da8b8e	3
200032	carvedilol 12.5 MG Oral Tablet	PSN	354d1689-53f9-42d3-8308-08b6d9a04404	2
200032	carvedilol 12.5 MG Oral Tablet	SCD	354d1689-53f9-42d3-8308-08b6d9a04404	2
200032	carvedilol 12.5 MG Oral Tablet	PSN	da8a670b-a9ce-445f-af31-7588c6c67e29	1
200032	carvedilol 12.5 MG Oral Tablet	SCD	da8a670b-a9ce-445f-af31-7588c6c67e29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-164-01	68462016401	100 TABLET, FILM COATED in 1 BOTTLE (68462-164-01)	2007-09-05	0000-00-00	No	No	Current
68462-164-05	68462016405	500 TABLET, FILM COATED in 1 BOTTLE (68462-164-05)	2007-09-05	0000-00-00	No	No	Current
68462-164-10	68462016410	1000 TABLET, FILM COATED in 1 BOTTLE (68462-164-10)	2007-09-05	0000-00-00	No	No	Current
68462-164-18	68462016418	180 TABLET, FILM COATED in 1 BOTTLE (68462-164-18)	2014-12-10	0000-00-00	No	No	Current
68462-164-60	68462016460	60 TABLET, FILM COATED in 1 BOTTLE (68462-164-60)	2007-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carvedilol	Bryant Ranch Prepack	2026-06-05	HUMAN PRESCRIPTION DRUG LABEL	10
Carvedilol	A-S Medication Solutions	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	41
Carvedilol	Major Pharmaceuticals	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	12
Carvedilol	H.J. Harkins Company, Inc. \| Glenmark Generics Inc., USA \| Glenmark Generics Limited	2011-12-08	HUMAN PRESCRIPTION DRUG LABEL	2
Carvedilol	RedPharm Drug Inc. \| Glenmark Generics Limited	2011-08-17	HUMAN PRESCRIPTION DRUG LABEL	1
Hypertenevide-12.5	Physician Therapeutics LLC \| Glenmark Generics Limited \| H.J. Harkins Company, Inc \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	7
Carvedilol	State of Florida DOH Central Pharmacy	2010-06-07	HUMAN PRESCRIPTION DRUG LABEL	3

Carvedilol

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

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#