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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078251-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078251-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078251-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078251-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078251-001	AB
A078251-002	AB
A078251-003	AB
A078251-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078251-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078251-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078251-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-004	AB	1	`d06236e962d9…`

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K47UL67F2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200031	Internal RxNorm lookup
200032	Internal RxNorm lookup
200033	Internal RxNorm lookup
686924	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c4a21f67-7812-4634-beba-f8e85c63c5f2	Available on FDA.report

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	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	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	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [GLENMARK GENERICS INC., USA]	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, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
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
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	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
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]	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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Major Pharmaceuticals	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	d7669550-adcc-4e70-83b1-c28ce75e7fda	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Cardinal Health 107, LLC	bd0f2596-a192-4b0e-836f-4a09816408a4	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	e285434f-d831-b6e7-e053-2995a90a1ab2	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	84ee5fbf-7299-4b8a-e053-2a91aa0aa159	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	A-S Medication Solutions	ee848543-12fb-446c-86db-bf2322ec986f	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	A-S Medication Solutions	3c8d54e6-835c-4fa7-b13b-b798916cfed3	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	c133b9c7-ab1a-e517-e053-2995a90a517a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Glenmark Pharmaceuticals Inc., USA	c4a21f67-7812-4634-beba-f8e85c63c5f2	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251 ndc (product): 68462-164
Carvedilol	CARVEDILOL	A-S Medication Solutions	e0ae5bed-1cb4-45d6-befe-dfc68edb9b34	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Proficient Rx LP	c03bd9d7-1e0b-49da-a14a-32e712dc3a2d	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251

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	Major Pharmaceuticals	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	6
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	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-10-27	HUMAN PRESCRIPTION DRUG LABEL	12
Carvedilol	Preferred Pharmaceuticals Inc.	2024-03-20	HUMAN PRESCRIPTION DRUG LABEL	3
Carvedilol	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	2
Carvedilol	Clinical Solutions Wholesale	2020-09-03	HUMAN PRESCRIPTION DRUG LABEL	10
Carvedilol	REMEDYREPACK INC.	2020-02-23	HUMAN PRESCRIPTION DRUG LABEL	6
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