Carvedilol

Product NDC: 68382-094
11-digit product format: 683820094
Labeler code: 68382
Product ID: 68382-094_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: 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077614-001	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A077614-002	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A077614-003	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05
A077614-004	CARVEDILOL	CARVEDILOL	3.125MG	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
A077614-001	AB
A077614-002	AB
A077614-003	AB
A077614-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077614-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077614-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carvedilol
Listing expiration: 2027-12-31

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
dc6a2d33-aa04-4a04-9cde-901b744d24ca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
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
68382-094-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
68382-094-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
68382-094-17	Carvedilol	28 in 1 BOTTLE	TABLET, FILM COATED	28	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-094-01	EA - Each	68382-094	6acaaa89-5a15-4637-84f4-b4b5a53d1c05	1	2012-07-24
68382-094-05	EA - Each	68382-094	72646414-e2ff-46f6-b33d-ce821d8eb5b4	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 [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOLEVULINIC ACID HYDROCHLORIDE	INACTIVE INGREDIENT	V35KBM8JGR	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOMETRADINE	INACTIVE INGREDIENT	PPM8SX5Q3V	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPENTAMIDE SULFATE	INACTIVE INGREDIENT	20P9NI883O	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPHYLLINE	INACTIVE INGREDIENT	27Y3KJK423	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPROMAZINE	INACTIVE INGREDIENT	S9SDD93U5U	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPROPAZINE FUMARATE	INACTIVE INGREDIENT	9KWA4W69IW	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPTERIN SODIUM	INACTIVE INGREDIENT	FZU1QI13O9	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMMI VISNAGA FRUIT	INACTIVE INGREDIENT	3UN285QN0C	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMOPROXAN	INACTIVE INGREDIENT	27RL57FCYM	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]	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
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	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	INACTIVE INGREDIENT	3NXW29V3WO	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	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	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
68382-094	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	15	Current NDC, Legacy NDC, 3 package rows	20231216_dc6a2d33-aa04-4a04-9cde-901b744d24ca.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Coupler LLC	58280d18-5960-1730-e063-6394a90a4f64	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	ab8aa773-0ed1-4d59-a1bb-f46cf882644f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	0e98593a-8424-48c8-acc0-671f4b566aee	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	32098c09-7580-4975-a3e1-31b619c04c69	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	196536eb-8b94-45da-a2f3-f554d6bf88e9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	39cf31cc-8f3d-4919-a93a-f997ad6850dc	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	ed11cd4e-d7c9-8446-e053-2995a90afd6e	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	51b403dc-fc9f-0cad-e063-6394a90af081	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	QPharma Inc	010290af-81f4-0037-e063-6394a90a4638	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	8a82149f-aade-2a9b-e053-2995a90a9daf	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals, Inc.	5c34847d-68f9-4967-81c8-a2297a6acb7f	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals Inc.	3b56e0d0-82d7-4512-849f-2b72d7bae36e	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	BluePoint Laboratories	e68c9b18-e7fd-45f7-a8f5-1d815e32680b	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Direct_Rx	4c48ba6b-4e1e-5116-e063-6394a90aa793	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Direct_Rx	4c0e089b-0199-43e2-e063-6394a90a7883	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	A-S Medication Solutions	3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614

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	39cf31cc-8f3d-4919-a93a-f997ad6850dc	20
200032	carvedilol 12.5 MG Oral Tablet	SCD	39cf31cc-8f3d-4919-a93a-f997ad6850dc	20
200032	carvedilol 12.5 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200033	carvedilol 25 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200031	carvedilol 6.25 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200032	carvedilol 12.5 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200033	carvedilol 25 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200031	carvedilol 6.25 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200032	carvedilol 12.5 MG Oral Tablet	PSN	3724c7f1-dd2a-4bc9-b388-17238d663860	8
200032	carvedilol 12.5 MG Oral Tablet	PSN	5c34847d-68f9-4967-81c8-a2297a6acb7f	8
200032	carvedilol 12.5 MG Oral Tablet	SCD	3724c7f1-dd2a-4bc9-b388-17238d663860	8
200032	carvedilol 12.5 MG Oral Tablet	SCD	5c34847d-68f9-4967-81c8-a2297a6acb7f	8
200032	carvedilol 12.5 MG Oral Tablet	PSN	ac14846e-423a-37c4-e053-2a95a90a3cdd	7
200032	carvedilol 12.5 MG Oral Tablet	SCD	ac14846e-423a-37c4-e053-2a95a90a3cdd	7
200032	carvedilol 12.5 MG Oral Tablet	PSN	df600dde-8ef9-52e3-e053-2a95a90a2dc0	4
200032	carvedilol 12.5 MG Oral Tablet	PSN	157f64c6-2c21-4056-b643-79047ca237a9	4
200032	carvedilol 12.5 MG Oral Tablet	PSN	196536eb-8b94-45da-a2f3-f554d6bf88e9	4
200033	carvedilol 25 MG Oral Tablet	PSN	196536eb-8b94-45da-a2f3-f554d6bf88e9	4
200032	carvedilol 12.5 MG Oral Tablet	SCD	196536eb-8b94-45da-a2f3-f554d6bf88e9	4
200032	carvedilol 12.5 MG Oral Tablet	SCD	157f64c6-2c21-4056-b643-79047ca237a9	4
200032	carvedilol 12.5 MG Oral Tablet	SCD	df600dde-8ef9-52e3-e053-2a95a90a2dc0	4
200033	carvedilol 25 MG Oral Tablet	SCD	196536eb-8b94-45da-a2f3-f554d6bf88e9	4
200032	carvedilol 12.5 MG Oral Tablet	PSN	f5572c43-61fe-459f-a40a-5cd7f26d1ec4	3
200032	carvedilol 12.5 MG Oral Tablet	SCD	f5572c43-61fe-459f-a40a-5cd7f26d1ec4	3
200032	carvedilol 12.5 MG Oral Tablet	PSN	8a82149f-aade-2a9b-e053-2995a90a9daf	2
200032	carvedilol 12.5 MG Oral Tablet	SCD	8a82149f-aade-2a9b-e053-2995a90a9daf	2
200032	carvedilol 12.5 MG Oral Tablet	PSN	d7736758-ad06-4ddb-bdf0-eda27a0acae5	1
200032	carvedilol 12.5 MG Oral Tablet	PSN	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	1
200032	carvedilol 12.5 MG Oral Tablet	SCD	d7736758-ad06-4ddb-bdf0-eda27a0acae5	1
200032	carvedilol 12.5 MG Oral Tablet	SCD	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-094-01	68382009401	100 TABLET, FILM COATED in 1 BOTTLE (68382-094-01)	2007-09-05	0000-00-00	No	No	Current
68382-094-05	68382009405	500 TABLET, FILM COATED in 1 BOTTLE (68382-094-05)	2007-09-05	0000-00-00	No	No	Current
68382-094-17	68382009417	28 TABLET, FILM COATED in 1 BOTTLE (68382-094-17)	2007-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carvedilol	Bryant Ranch Prepack	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	REMEDYREPACK INC.	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL	21
Carvedilol	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	1
Carvedilol	St. Mary's Medical Park Pharmacy	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	2
Carvedilol	Preferred Pharmaceuticals, Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	8
Carvedilol	A-S Medication Solutions	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	8
Carvedilol	A-S Medication Solutions	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	4
Carvedilol	PD-Rx Pharmaceuticals, Inc.	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Carvedilol	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited \| Zydus Pharmaceuticals Limited	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	16
Carvedilol	Legacy Pharmaceutical Packaging, LLC	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	14
Carvedilol	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Carvedilol	NuCare Pharmaceuticals,Inc.	2025-01-02	HUMAN PRESCRIPTION DRUG LABEL	7
Carvedilol	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Carvedilol	State of Florida DOH Central Pharmacy	2010-05-20	HUMAN PRESCRIPTION DRUG LABEL	1